[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ulcerative-colitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ulcerative-colitis":577},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,169,0,25,[9,44,76,87,107,135,158,181,207,226,246,272,293,312,334,360,381,401,421,440,470,490,510,536,557],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053628",false,"NCT07619547","Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAffected Participant cohort:\n\n1. Adults 18 - 85 years of age\n2. History of:\n\n   1. a verifiable diagnosis of Crohn's disease, ulcerative colitis, or IBD known to be associated with a co-existing condition (such as CTLA4 deficiency or common variable immune deficiency) and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes related to chronic inflammation; and\u002For\n   2. a defined genetic syndrome\u002Fmutation linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD\n3. Presence of a referring community physician who would be able to manage care outside of NIH\n\nUnaffected family member of participant:\n\nImmediate relative to the enrolled participant (mother, father, sibling, or adult child) may be recruited and enrolled to improve interpretation of genetic results or expand the phenotype of the IBD\n\n1. Adults 18 - 99 years of age\n2. In good general health\n3. No medical diagnosis of IBD\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Unable or unwilling to provide informed consent\n2. Evidence of significant medical illnesses that the investigators feel may interfere with study evaluations and procedures","ALL","18 Years","85 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","Background:\n\nInflammatory bowel disease (IBD) is a term used to describe disorders that cause long-term inflammation in the digestive tract. Symptoms include stomach pain, diarrhea, and bleeding. Crohn's disease and ulcerative colitis are the 2 main types of IBD. Researchers want to conduct a natural history study to learn more about whether genetic factors can cause IBD; how immune cells contribute to IBD; and how diet, drugs, and disease affect those cells.\n\nObjective:\n\nTo better understand IBD over time.\n\nEligibility:\n\nAdults aged 18 to 85 years with Crohn's disease, ulcerative colitis, or another IBD. Their healthy relatives are also needed.\n\nDesign:\n\nAffected participants will have clinic visits every 6 months for 3 years.\n\nOnce a year, they will have these procedures:\n\nA physical exam with blood and stool samples.\n\nUltrasound of the abdomen. A wand will be rolled over the skin. It uses sound waves to capture images of the intestines.\n\nMagnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Magnetic fields will capture images of the intestines.\n\nColonoscopy. A long, flexible tube with a video camera will be inserted into the rectum to view the entire colon. Up to 12 tissue samples may be taken.\n\nUpper endoscopy, for those with Crohn's disease. A long, thin tube with a camera will be inserted through the mouth and into the first part of the small intestine. Up to 12 small tissue samples may be taken.\n\nQuestionnaires. Participants will answer questions about their disease and their diet.\n\nMidyear visits will include a physical exam, blood and stool collection, ultrasound, and questionnaires\n\nHealthy relatives will have 1 blood draw for genetic tests.",[24,25,26],"Inflammatory Bowel Disease","Crohn's Disease","Ulcerative Colitis",[28,29,30],"Immune System","Inflammation","gastroenterology","NOT_YET_RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":20},"2026-07-16",{"date":39,"type":20},"2036-06-01",{"name":41,"class":42},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":45,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100053737","NCT07697456","Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","Inclusion Criteria:\n\nCD specific:\n\n* Crohn's Disease Activity Index (CDAI) score of ≥ 220\n* Confirmed diagnosis of CD at least 90 days prior to Baseline\n* Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.\n* Demonstrated failure of 1 or more therapy for CD\n\nUC specific:\n\n* Confirmed diagnosis of UC at least 90 days prior to Baseline\n* Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3\n* Demonstrated failure of 1 or more therapy for UC\n\nExclusion Criteria:\n\n* Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)\n* Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment\n* Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame\n* Participants with surgical bowel resection within the past 3 months prior to Baseline\n\nCD specific:\n\n* Participants with \\>3 prior bowel resections\n* Participants with previous small bowel resection(s) of combined length \\>100 cm\n\nUC specific:\n\n* Participants with prior colectomy (total or subtotal)\n* Participants with extent of disease limited to \\\u003C 10 cm of rectum","75 Years",{"count":52,"type":20},2000,"INTERVENTIONAL",[55],"PHASE2","Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC).\n\nThis study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.",[25,26],[59,60,61,62,63,64,65],"Crohn's disease","Ulcerative colitis","Risankizumab","ABBV-701","Trosunilimab","ABBV-466","ABBV-7066","2026-07-07",{"date":34,"type":35},{"date":69,"type":20},"2026-07-24",{"date":71,"type":20},"2031-10",{"name":73,"class":74},"AbbVie","INDUSTRY",30,{"id":77,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":79,"keywords":80,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":85,"leadSponsor":86,"locationsCount":43},"100641419",{"count":19,"type":20},[24,25,26],[28,29,30],"2026-07-01",{"date":83,"type":35},"2026-07-02",{"date":66,"type":20},{"date":39,"type":20},{"name":41,"class":42},{"id":88,"slug":4,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":50,"enrollmentInfo":93,"targetDuration":4,"studyType":53,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100628557","NCT07463183","A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)","A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants With Moderately to Severely Active Ulcerative Colitis","The main inclusion criteria include but are not limited to the following:\n\n* Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before Randomization\n* Has moderately to severely active UC\n* Has a weight ≥40 kg\n* Satisfies at least 1 of the criteria: Has had an inadequate response or loss of response to 1 or more protocol-specified treatments; protocol specified corticosteroid dependence; has been intolerant to 1 or more protocol-specified UC treatments\n* Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment\n* Has a current diagnosis of fulminant colitis and\u002For toxic megacolon\n* Has UC limited to the rectum\n* Has a current or impending need for colostomy or ileostomy\n* Has had a total proctocolectomy or partial colectomy\n* Has UC exacerbation requiring hospitalization within 2 weeks before Screening\n* Has any active infection as specified in the protocol\n* Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\n* Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters\n* Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years before Randomization or has a history of colorectal cancer at any time\n* Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed\n* Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study\n* Has received protocol-specified prohibited medications",{"count":19,"type":20},[55],"The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.",[97,26],"Colitis Ulcerative","RECRUITING",{"date":83,"type":35},{"date":101,"type":35},"2026-03-24",{"date":103,"type":20},"2028-12-21",{"name":105,"class":74},"Merck Sharp & Dohme LLC",11,{"id":108,"slug":4,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":53,"phases":115,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":43},"100628048","NCT07456566","Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease","Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial","Inclusion Criteria:\n\n* Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, endoscopic, and histopathological criteria, clinically active IBD\n* Impaired health-related quality of life\n* Clinically active IBD will be indicated by both a modified Harvey Bradshaw Index (HBI) ≥5 for Crohn's disease (CD) or a Simple Clinical Colitis Activity Index (SCCAI) ≥3 for ulcerative colitis (UC)\n* Fecal calprotectin \\> 250 microgram (ug\u002Fg)\n* Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60\n\nExclusion Criteria:\n\n* Unable to speak and read English\n* Unable to access the internet regularly by phone or web as this will impair participants ability to engage with the intervention components\n* Have an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses\n* Are planned for imminent surgery\n* Have short bowel syndrome\n* Uncontrolled medical or psychiatric disease",{"count":114,"type":20},40,[116],"NA","This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease.\n\nThe study team hypothesizes:\n\n* the study will achieve a recruitment rate of 10 participants every 3 months\n* 70% participant retention at 24 weeks\n* 70% outcome data collection\n* 70% intervention completion\n* high acceptability",[119,26,120],"Inflammatory Bowel Diseases","Crohn Disease",[122,123,124,125],"Digital self-management program","Standard of care","Randomization","Questionnaires","2026-06-30",{"date":83,"type":35},{"date":129,"type":20},"2026-07",{"date":131,"type":20},"2028-03",{"name":133,"class":134},"University of Michigan","OTHER",{"id":136,"slug":4,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":50,"enrollmentInfo":141,"targetDuration":4,"studyType":53,"phases":143,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100613360","NCT07265570","Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)","A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of ISM5411 in Adult Patients With Active Ulcerative Colitis","Inclusion Criteria:\n\n1. Subject who fully understand the content, process and possible adverse events of the study and capable of giving written informed consent form (ICF).\n2. Female subjects must be nonpregnancy and nonlactating. Subjects (male or female) are willing to take medically approved effective contraceptive measures from the screening period to 3 months after the last administration and have no sperm or egg donation plan during the study period and within 3 months after the last dose.\n3. Male or female between 18 and 75 years of age (inclusive), at the time of signing the ICF.\n4. Subject has a diagnosis of ulcerative colitis for at least 3 months prior to colonoscopy during the screening period, and meets the criteria defined in the current protocol.\n5. If the subjects have concomitant medication defined in the current protocol, they must meet the relevant criteria to be enrolled.\n6. If the subjects have discontinued medication defined in the current protocol, they must meet the relevant criteria to be enrolled.\n\nExclusion Criteria:\n\n1. Subjects have suspected or diagnosed Crohn's disease (CD), undefined colitis, ischemic colitis, fulminant colitis, toxic megacolon, radiation colitis, gastrointestinal perforation (other than appendicitis or penetrating injury), diverticular disease associated with colitis, enterophthisis, abdominal abscess or fistula, etc.\n2. Subjects with previously diagnosed but uneradicated or current gastrointestinal dysplasia.\n3. Subjects have received surgery for UC or any other type of major intestinal surgery (i.e., surgical procedure requiring general anesthesia) or are likely to require related surgery during the study.\n4. Subjects have evidence of a pathogenic intestinal infection, or have a Clostridium Difficile infection or other intestinal infection within 30 days prior to the screening endoscopy or have tested positive for Clostridium Difficile toxins or other intestinal pathogens at the screening period.\n5. Subjects have chronic recurring infection and\u002For active viral infection that, based on the investigator's clinical assessment, make them an unsuitable candidate for the study.\n6. Subjects who are unable to take oral medications and\u002For have an impact on absorption of medication due to severe malnutrition or disease and surgery, etc., or who are currently receiving or plan to receive total parenteral nutrition (TPN) during the study period.\n7. Subjects who have received the relevant treatments defined in the protocol.\n8. Subjects with recurrent or disseminated (even if single episode) herpes zoster, or cytomegalovirus infection.\n9. Subjects who have the risks of tuberculosis defined in the protocol.\n10. Subjects have any of the infection defined in the protocol.\n11. Subjects who are known to be allergic to the investigational product or any components of it or who have allergic constitution (allergy to multiple drugs or foods).\n12. Subjects have unstable or uncontrolled and clinically significant allergic (except for untreated, asymptomatic, seasonal allergies), hematological, endocrine\u002Fmetabolic, coagulation, immunologic, pulmonary, cardiovascular, hepatic (expect hepatic steatohepatitis), digestion system (expect UC), genitourinary, psychiatric, oncologic or neurological disease or other medical disorder that would make them ineligible for the study.\n13. Subjects have concomitant illness that in the opinion of the investigator, are likely to require systemic glucocorticosteroid therapy during the study (e.g., moderate to severe asthma).\n14. Subjects have received major organ surgery (except needle biopsy, tracheotomy, gastrotomy, etc.) or significant trauma within 28 days prior to randomization or is likely to require related surgery during the study.\n15. Subjects have history of any malignancy within 5 years of screening, except for successfully treated nonmelanoma skin cancer (NMSC), skin basal cell carcinoma, or localized carcinoma in situ of the cervix.\n16. Any abnormal results defined in the protocol were identified during the screening period.\n17. Subjects with poorly controlled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg) despite medication at screening.\n18. Subjects have a clinically significant abnormal ECG at screening, including QTcF \\> 450 msec for males and \\> 470 msec for females.\n19. Subjects have difficulty in venous blood collection or history of acupuncture syncope reaction or blood phobia.\n20. Subjects have contraindications to colonoscopy, including but not limited to gastrointestinal fistulas, early post abdominal surgery, severe coagulopathy, large abdominal aneurysms, or any condition that the investigator determines significantly increases the risk of colonoscopy complications.\n21. Subjects have a history of alcohol or drug abuse within 3 months of screening, according to the judgement of the investigator. Alcohol abuse refers to consuming alcohol at least twice per day or more than 14 units of alcohol per week.\n22. Subjects have participated in other clinical trials of other drugs or medical devices within 30 days prior to screening period and have already received the investigational product, or are currently participating in another clinical trial of a drug or medical device.\n23. Subjects are deemed by the investigator to be inappropriate for the study; or have any condition which would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or are unable or unwilling to comply with the study protocol.",{"count":142,"type":20},80,[55],"This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of ISM5411 in adult patients with active ulcerative colitis.",[26],[147,148,149],"Prolyl hydroxylase (PHD) inhibitor","Ulcerative colitis（UC）","Inflammatory bowel disease (IBD)",{"date":81,"type":35},{"date":152,"type":35},"2025-12-10",{"date":154,"type":20},"2027-08-30",{"name":156,"class":74},"InSilico Medicine Hong Kong Limited",28,{"id":159,"slug":4,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":53,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":178,"locationsCount":180},"100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":166,"type":20},645,[55],"This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[26,119,170,171],"Colitis","Colitis, Ulcerative","2026-06-26",{"date":174,"type":35},"2026-06-29",{"date":176,"type":35},"2025-05-27",{"date":131,"type":20},{"name":179,"class":74},"Spyre Therapeutics, Inc.",243,{"id":182,"slug":4,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":15,"minAge":186,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":53,"phases":190,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":203,"leadSponsor":205,"locationsCount":43},"100631469","NCT07501078","Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation","Inclusion Criteria:\n\n* Must be able to give written informed consent (or assent as appropriate)\n* Must have the following: UC with ileal pouch-anal anastomosis (IPAA) using a J-pouch without an ileostomy within the last eight months\n* For pre-menopausal women 11 years of age and older with intact reproductive organs, a negative pregnancy test is required within two weeks prior to the baseline visit. Participants in this age group must agree to use an acceptable form of contraception throughout the study per protocol.\n\nExclusion Criteria:\n\n* Female subjects must not be pregnant or lactating; and female of childbearing potential unwilling to use acceptable birth control throughout the study.\n* Must not be participating in any other interventional trial using an investigational drug.\n* Subjects likely to be uncooperative or unable to comply with study procedures\n* History or diagnosis of Crohn's disease\n* History or diagnosis of hereditary gastrointestinal (GI) syndromes, Severe gastrointestinal bleeding\u002Fcomplications, (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors).\n* History or diagnosis of any gastrointestinal malignancy\n* Kidney disease, including kidney \"stones\" or hypercalcemia. acute renal failure (past 12 weeks). (Note: A doubtful stone passed in the urine more than three years ago is not considered evidence of current renal stone disease.)\n* Congenital coagulopathies or hereditary hemorrhagic disorders; treatment with therapeutic doses of warfarin or heparin\n* Participants will be excluded if they have used any of the following within the past 30 days or are unwilling to withdraw for 30 days prior to entering into the study:\n\n  * Calcium, Magnesium, including multivitamins that have low amounts of Calcium\u002FMagnesium and fiber supplements. (Multivitamins without any minerals are allowed).\n  * Non-steroidal anti-inflammatory medications (NSAIDs), such as Naproxen or Ibuprofen (except for occasional pain control or low dose aspirin for cardiovascular disease prevention) per protocol.\n  * Oral or rectal Corticosteroids (a type of steroid drug such as prednisone or cortisol that helps the body to regulate stress response, immune response and inflammation) and antibiotics (except these can be used briefly during a flare-up once the study treatment has begun after the subject enrolled, if prescribed by the personal physician). Inhaled and skin corticosteroids preparations are ok and not an exclusion criteria.","5 Years","80 Years",{"count":189,"type":20},52,[55],"Ulcerative colitis (UC) is a disease that causes long-term inflammation in the digestive tract, and many people with this condition require surgery to remove the colon and create a new J-pouch for stool. Some patients develop a problem called pouchitis, where this pouch becomes inflamed. Current treatments are limited, and there are no known ways to prevent pouchitis from starting. This study is being done to find out if a natural mineral supplement called Aquamin® can help reduce inflammation and protect the gut lining in people with a J-pouch, and may reduce the risk of pouchitis. By understanding whether Aquamin® is safe and helpful, the study team hopes to find a new and better way to prevent inflammation and improve the long-term health of people with UC.",[26,193],"Ileal Pouch",[195,196,197,198,199,124],"J-pouch without an ileostomy","Surveys","Sample collection","Placebo","Aquamin®","2026-06-25",{"date":174,"type":35},{"date":129,"type":20},{"date":204,"type":20},"2029-05",{"name":206,"class":134},"Muhammad N Aslam, MD",{"id":208,"slug":4,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":53,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100591354","NCT06979336","A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)","A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n* Diagnosis of ulcerative colitis (UC) established at least 3 months\n* Moderately to severely active UC assessed by mMS\n* Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC\n\nExclusion Criteria:\n\n* Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC\n* Diagnosis of Crohn's disease or indeterminate colitis\n* Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)\n* Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and\u002For IL-23",{"count":214,"type":20},224,[55],"The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and\u002For advanced therapies has failed.",[26],{"date":172,"type":35},{"date":220,"type":35},"2025-09-29",{"date":222,"type":20},"2028-10-31",{"name":224,"class":74},"Genentech, Inc.",101,{"id":227,"slug":4,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":187,"enrollmentInfo":233,"targetDuration":4,"studyType":53,"phases":235,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":225},"100560759","NCT06581328","A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting","A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting","PANORAMA","Inclusion Criteria\n\nTo be eligible to participate in this study, participants must meet all the following criteria:\n\n1. In the investigator's opinion, the participant can understand and comply with protocol requirements.\n2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.\n3. The participant is 18 to 80 years of age at the time of signing the ICF.\n4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI).\n5. If participant is a woman of childbearing potential (WOCBP):\n\n   1. Agrees to use at least 1 form of highly effective contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab.\n   2. Agrees to avoid donating ova from signing the ICF throughout the duration of the study and for 18 weeks after the last dose of vedolizumab.\n   3. Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.\n   4. Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.\n6. If participant is a fertile man:\n\n   1. Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab\n   2. Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose.\n7. The participant has a diagnosis of moderate to severely active UC or CD defined by the following:\n\n   1. CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \\>=6 (\\>=4 if isolated ileal disease) at screening OR\n   2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy subscore of 2 to 3 at screening\n8. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.\n9. Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and\u002For advanced therapy.\n\nExclusion Criteria\n\nParticipants who meet any of the following exclusion criteria will be excluded from participation in this study:\n\n1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \\[AMG 181\\]) at any time prior to screening.\n2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.\n3. Use of corticosteroid enemas\u002Fsuppositories within 2 weeks prior to screening (for UC and CD).\n4. In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration \\[FDA\\] 2024).\n5. Received any investigational biologic therapy \\\u003C= 6 months prior to screening.\n6. The participant has received an advanced treatment for an approved indication other than CD or UC. Advanced therapy include: TNF inhibitors (e.g. infliximab, adalimumab, certolizumab pegol), and IL 12\u002F23 antagonist (e.g. ustekinumab, mirikizumab, risankizumab); and small molecules include JAK inhibitor (e.g. tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) receptor modulator (e.g. etrasimod, ozanimod).\n7. The participant has any evidence of an active infection during screening.\n8. Ileostomy, colostomy, severe, or symptomatic stenosis of the intestine or short bowel syndrome.\n9. A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period.\n10. History of malignancy, except for the following: adequately treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Participants with a remote history of malignancy (example, greater than (\\>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received; this must be discussed with the sponsor on a case-by-case basis prior to enrollment.\n11. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion.\n12. Has laboratory abnormalities during the screening period.",{"count":234,"type":20},400,[236],"PHASE4","Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).\n\nParticipants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab.\n\nDuring the study, participants will visit their study clinic several times.",[26,25],{"date":172,"type":35},{"date":241,"type":35},"2025-03-27",{"date":243,"type":20},"2028-06-01",{"name":245,"class":74},"Takeda",{"id":247,"slug":4,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":15,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":53,"phases":257,"briefSummary":259,"conditions":260,"keywords":261,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100598440","NCT07071519","A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis","A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to \u003C 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis","MIGHTY","Inclusion Criteria:\n\n* Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).\n* Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:\n\naminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and\u002For biologic therapies, as outlined in the protocol.\n\n\\- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and\u002For malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available.\n\nExclusion Criteria:\n\n* Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection).\n* Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.","2 Years","17 Years",{"count":256,"type":20},120,[258],"PHASE3","Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed.\n\nRisankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide.\n\nParticipants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[26],[262],"risankizumab","2026-06-22",{"date":265,"type":35},"2026-06-24",{"date":267,"type":35},"2025-07-28",{"date":269,"type":20},"2034-07",{"name":73,"class":74},53,{"id":273,"slug":4,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":254,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":43},"100533633","NCT06228352","Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis","Is Clostridioides Difficile Infection Associated With Changes in Bile Acid Profiles in Children With Ulcerative Colitis","ABRICO","For everyone :\n\nInclusion Criteria:\n\n* Pediatric patients (\\\u003C18 years) consultant or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital.\n* Information and consent of parents and the patient\n\nExclusion Criteria:\n\n* Patient who received antibiotic or antifungal treatment in the 4 weeks prior to inclusion.\n* Patients colonized by C. difficile.\n* Pregnant or breastfeeding young girl.\n* Refusal of the protocol by parents or patient.\n\nFor group 1: Patients with active UC\n\nInclusion criteria:\n\n* Patient with UC, whatever the extent, except isolated proctitis (\\\u003C5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria.\n* UC in flare defined by a PUCAI score of between 35 and 65.\n\nNon-inclusion criteria:\n\n* Patient with IBD unclassified or Crohn's disease.\n* Patient with isolated proctitis (\\\u003C5 cm).\n* Colectomized patients.\n* Patients with sclerosing cholangitis associated with their UC or liver disease.\n\nGroup 2: Patients in UC remission\n\nInclusion criteria:\n\n* Patient with UC, whatever the extent, except isolated proctitis (\\\u003C5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria.\n* UC in remission defined by a PUCAI score \\\u003C10.\n\nNon-inclusion criteria:\n\n* Patient with IBD unclassified or Crohn's disease.\n* Patient with isolated proctitis (\\\u003C5 cm).\n* Colectomized patients.\n* Patients with sclerosing cholangitis associated with their UC or liver disease.\n\nGroup 3: Healthy control subjects\n\nInclusion criteria:\n\n\\- Patients hospitalized for an endoscopic assessment to control for abdominal pain, gastroesophageal reflux or polyposis.\n\nNon-inclusion criteria:\n\n* Patient with chronic liver disease.\n* Patient with chronic digestive disease (celiac disease, IBD, chronic chronic).",{"count":142,"type":20},"Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease characterized by chronic inflammation of the colon. Composition of gut microbiota of UC patients is abnormal (dysbiosis).\n\nUlcerative Colitis patients have an increased risk of Clostridioides difficile infection (CDI) and CDI complications (colectomy, death, recurrence). The reason for this increased risk in IBD patients is not fully understood. The decrease in the proportion of secondary bile acids, induced by microbiota dysbiosis in patients with UC could favor C. difficile infection.\n\nThe main objective of the study is to describe the composition of bile acids (primary and secondary) in children followed for UC during relapse with or without CDI and to compare it to children with UC in remission and healthy controls. The composition of fecal microbiota will be also describe to correlate dysbiosis and bile acid abnormalities. And finally some fecal biomarkers will be study : short chain fatty acids, metabolic pathway of Tryptophan, and fecal Calprotectin.",[26],[60,283,284,285],"Clostridioides difficile infection","Intestinal dysbiosis","Bile acid profiles",{"date":265,"type":35},{"date":288,"type":35},"2026-06-09",{"date":290,"type":20},"2029-06",{"name":292,"class":134},"Assistance Publique - Hôpitaux de Paris",{"id":294,"slug":4,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":15,"minAge":299,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":43},"100612225","NCT07250815","A Study on Infections in Adults With Ulcerative Colitis\u002FCrohn's Disease","Infection Outcomes Among Advanced Therapy-naive Older Adult US Patients With UC\u002FCD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025","Inclusion Criteria:\n\nUC Study Cohort:\n\nParticipants will be included if they had:\n\n-Greater than or equal to (\\>=) 1 medical (for Medicare fee-for-service \\[FFS\\], Part A\u002FB) or pharmacy claim (for Medicare FFS, Medicare Part D) for an approved AMT for UC during the participant identification period.\n\nNote: Claim should be on or after the food and drug administration (FDA) treatment-specific approval dates for each drug.\n\nThe date of the first claim during the participant identification period will be designated the Index Date, and the corresponding AMT, the index AMT.\n\n* \\>=2 medical (for Medicare FFS, Part A\u002FB) claims, at least 30 days apart, with an ICD-10-CM code for UC during the baseline period or on the Index Date.\n* Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.\n\nCD Study Cohort:\n\nParticipants will be included if they had:\n\n\\- \\>=1 medical (for Medicare FFS, Part A\u002FB) or pharmacy claim (for Medicare FFS, Part D) for an approved AMT for CD during the Participant Identification Period.\n\nNote: Claim should be on or after the FDA treatment-specific approval dates for each drug.\n\nThe date of the first claim during the Patient Identification Period will be designated the Index Date, and the corresponding AMT, the index AMT.\n\n* \\>=2 medical (for Medicare FFS, Part A\u002FB) claims, at least 30 days apart, with an ICD-10-CM code for CD during the Baseline Period or on the Index Date.\n* Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.\n\nIf a participant has both a UC and CD diagnosis during the baseline period or on the index date, the diagnosis most proximate to or on the index date will be used to categorize the participant as having UC or CD.\n\nExclusion Criteria:\n\nParticipants with any of the following will be excluded from the analysis:\n\n* Any evidence of AMT utilization during the Baseline Period.\n* Participants with at least 2 ICD-10-CM codes for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, non-infectious uveitis, or psoriatic arthritis during the Baseline Period.\n* Participants with 2 or more ICD-10-CM codes for non-dermatologic malignancy during the Baseline Period.","65 Years",{"count":301,"type":20},23900,"More older people (more than 65 years of age) around the world are getting Ulcerative Colitis (UC) or Crohn's Disease (CD). This is happening because people are living longer and because more people overall are developing UC or CD. Medicines that treat UC\u002FCD, however, might make it easier for older adults to get infections.\n\nThe main aim of this study is to learn if there is a difference in the number and type of infections in older people when treated with either ENTYVIO or other advance medicines (TNF-alpha inhibitors or ustekinumab) that reduce swelling and pain by blocking a chemical in the body (called TNF-alpha).\n\nThe study will include people aged 65 years and older UC or CD who used either ENTYVIO with ustekinumab or a TNF-alpha inhibitor between 2016 and 2025.\n\nData will be collected from existing Medicare databases.",[26,25],"2026-06-19",{"date":306,"type":35},"2026-06-23",{"date":308,"type":20},"2026-07-15",{"date":310,"type":20},"2026-12-15",{"name":245,"class":74},{"id":313,"slug":4,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":53,"phases":322,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100588107","NCT06937086","Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study","A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight","COMMIT-UC","Inclusion Criteria:\n\n* Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.\n* Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.\n* Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.\n* Have obesity, \\[body mass index (BMI) 30 kilograms per meter squared (kg\u002Fm2)\\]\n* Have overweight (BMI ≥27 kg\u002Fm2 to \\\u003C30 kg\u002Fm2) and in the presence of at least 1 of these weight-related comorbid conditions:\n\n  * hypertension\n  * Type 2 Diabetes Mellitus (T2DM)\n  * dyslipidemia\n  * obstructive sleep apnea, or\n  * cardiovascular disease.\n* Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and\u002For who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example, ustekinumab.\n\nExclusion Criteria:\n\n* Have a current diagnosis of:\n\n  * Crohn's disease\n  * inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis.\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery.\n* Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.\n* Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.\n* Have a history of severe hypoglycemia and\u002For hypoglycemia unawareness within the 6 months prior to screening.\n* Have a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.\n* Have a current or recent acute, active infection.","70 Years",{"count":321,"type":20},350,[258],"The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight.\n\nParticipation in this study will last up to 61 weeks, including 52 weeks of treatment.",[26,325],"Obesity or Overweight",{"date":306,"type":35},{"date":328,"type":35},"2025-06-26",{"date":330,"type":20},"2028-04",{"name":332,"class":74},"Eli Lilly and Company",189,{"id":335,"slug":4,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":15,"minAge":253,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":53,"phases":344,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":359},"100427330","NCT04844606","A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)","A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease","SHINE-ON","Inclusion Criteria:\n\n* Participants from originating studies (I6T-MC-AMBA \\[NCT05784246\\], I6T-MC-AMBU \\[NCT04004611\\], I6T-MC-AMAM \\[NCT03926130\\]) , I6T-MC-AMAY \\[NCT05509777\\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab\n* Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.\n* Female participants must agree to contraception requirements.\n\nExclusion Criteria:\n\n* Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.\n* Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.\n* Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.\n* Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.\n* Participants must not have adenomatous polyps that have not been removed.\n* Participants must not be pregnant or breastfeeding.","19 Years",{"count":343,"type":20},150,[258],"The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.",[26,347,119,25],"Ulcerative Colitis Chronic",[349,350,351,352],"Pediatric Ulcerative Colitis","Pediatric Crohn's Disease","Pediatric UC","Pediatric CD",{"date":306,"type":35},{"date":355,"type":35},"2021-05-26",{"date":357,"type":20},"2030-12",{"name":332,"class":74},68,{"id":361,"slug":4,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":187,"enrollmentInfo":367,"targetDuration":4,"studyType":53,"phases":369,"briefSummary":370,"conditions":371,"keywords":372,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":377,"leadSponsor":379,"locationsCount":43},"100644225","NCT07665294","Combination CurQD and Vedolizumab in Ulcerative Colitis","CURVE-UC: A Pragmatic Randomized, Double-blind, Placebo Controlled, Treat-through, Multi-site Pragmatic Interventional Study to Evaluate the Efficacy and Safety of Combination Curcumin-QingDai (CurQD) With Vedolizumab in Moderate to Severe Ulcerative Colitis (UC)","Curve UC","Inclusion Criteria:\n\n* Age 18 to 80 years old (inclusive) at time of consent\n* Understand and sign the written voluntary informed consent form prior to any protocol specific procedures\n* History of established UC for \\>3 months as determined by standard clinical criteria\n* Active UC defined as a modified Mayo score of 5-9 with a rectal bleeding sub score \\[RBS\\] ≥1 and Mayo endoscopic score \\[MES\\] ≥2\n* Participant will have a minimum disease extent of at least 5 cm proximal from the anal verge\n* Subjects must be on stable doses of concomitant medications, defined as:\n\n  * Participants on oral corticosteroids must be on a stable dose \\>2 weeks (dose not exceeding 20 mg\u002Fday prednisone, 9mg\u002Fday of budesonide, or equivalent) prior to screening\n  * Participants on methotrexate (MTX), azathioprine (AZA), or 6-mercaptopurine (6-MP) must be on treatment at a stable dose \\>4 weeks prior to screening and until end of study\n  * Participants on oral 5-aminosalicylates, mesalamine, or sulfasalazine must be on a stable dose for \\>4 weeks prior to screening and until end of study\n  * Probiotics or anti-diarrheal at a stable dose ≥ 2 weeks prior to Screening and until the end of study\n* Participants who have been diagnosed with UC for ≥8 years must be up to date on their colorectal cancer screening per local guidelines by the time of randomization.\n\nExclusion Criteria:\n\n* Diagnosis of inflammatory bowel disease unclassified (IBD-U) or Crohn's colitis\n* Previously received VDZ or etrolizumab (another anti-integrin biologic therapy)\n* Receiving corticosteroids at a dose \\>20mg\u002Fday of prednisone within two weeks prior to enrollment\n* Participants who have been exposed to more than one advanced therapy medication (biologic or small molecule drug) before enrollment will be excluded\n* Receiving or planned concomitant biologic or small targeted small molecule advanced therapy (tumor necrosis factor antagonist, interleukin \\[IL\\]-12\u002F23 antagonist, IL-23 antagonist, Janus kinase \\[JAK\\] inhibitor and\u002For sphingosine-1-phosphate \\[S1P\\] receptor modulator) with vedolizumab\n* Any calcineurin inhibitor use within 4 weeks prior to screening (e.g., cyclosporine, tacrolimus)\n* Participant with known hepatitis B or C infection\n* Participant with active or latent tuberculosis (that has not been adequately treated)\n* Participant has any active infection\n* Participant has fecal sample positive for enteric infection at screening\n* History of prior colectomy or ileal pouch anal anastomosis\n* Participants with fulminant UC, toxic megacolon, or hospitalized for UC currently or within prior 2 weeks\n* Severe lab abnormalities including hemoglobin \\\u003C 8.0 g\u002Fdl, albumin \\\u003C 3.0 g\u002Fdl, platelets \\\u003C 100\u002Fmcl, AST \\> 2X upper limit of normal (ULN), ALT \\>2X ULN, total bilirubin \\>1.5X ULN\n* Participant with history of colon cancer or colonic dysplasia not adequately treated (i.e. polyp removed)\n* Any serious underlying disease other than UC that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study or would compromise participant safety (such as any unstable or uncontrolled medical disorder, class III or IV congestive heart failure, demyelinating disease)\n* History of primary sclerosing cholangitis\n* Renal impairment and reduced creatinine clearance defined as estimated glomerular filtration rate GFR (eGFR)\\\u003C60mL\u002Fmin\n* History of chronic liver disease (autoimmune hepatitis, cirrhosis, etc.)\n* Currently requiring total parental nutrition\n* History of solid organ transplantation\n* History of malignancy or lymphoproliferative disorder in the prior 5 years, other than\n* adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous\n* cell carcinoma, or nonmetastatic basal cell carcinoma of the skin.\n* History of venothromboembolism (DVT or PE) or known inherited or acquired hyper coagulation disorder\n* Currently taking anti-platelet agent (other than aspirin) or anti-coagulant (coumadin,\n* rivaroxaban, etc.)\n* History of human immunodeficiency virus (HIV) infection\n* Participant is pregnant or lactating or actively trying to become pregnant",{"count":368,"type":20},160,[236],"The purpose of this research study is to test the efficacy and safety of the study intervention, CurQD or placebo (non-active pill), in combination with vedolizumab prescribed as standard of care for patients with ulcerative colitis (UC)..",[26],[373],"ulcerative colitis","2026-06-18",{"date":265,"type":35},{"date":265,"type":20},{"date":378,"type":20},"2027-06-23",{"name":380,"class":134},"Ryan C Ungaro",{"id":382,"slug":4,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":15,"minAge":253,"maxAge":254,"enrollmentInfo":387,"targetDuration":4,"studyType":53,"phases":389,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":400},"100547216","NCT06405087","A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)","A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease","Inclusion Criteria for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for participants with UC is defined as a reduction of partial Mayo score of \\>=2 points and \\>= 25 percentage (%) from baseline (from VedolizumabSC-3003 \\[NCT06100289\\]), including a \\>=1-point decrease in the Mayo stool frequency subscore and a \\>=1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of less than or equal to (\\\u003C=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) \\\u003C=30 with a reduction in the PCDAI of \\>=15 points from baseline (from VedolizumabSC-3003 \\[NCT06100289\\]).\n\nInclusion Criteria for Observational Cohort\n\n1\\. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study.\n\nExclusion Criteria for Treatment Cohort\n\n1. Has hypersensitivity or allergies to vedolizumab or any of its excipients.\n2. The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.",{"count":388,"type":20},70,[258],"The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.\n\nIn this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \\[NCT06100289\\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study.\n\nDuring the study, participants will visit their study clinic several times.",[26,25],[393],"Drug Therapy",{"date":263,"type":35},{"date":396,"type":35},"2025-10-27",{"date":398,"type":20},"2030-08-12",{"name":245,"class":74},54,{"id":402,"slug":4,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":409,"conditions":410,"keywords":411,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":420},"100574855","NCT06764706","Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis","A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC)","Inclusion Criteria:\n\n* Participants with an endoscopically confirmed diagnosis of moderate to severe ulcerative colitis.\n* Participants initiating risankizumab at the investigator's discretion as part of their routine clinical care; the decision to administer risankizumab must be made prior to and independent of documentation for the study and according to the approved local label.\n\nExclusion Criteria:\n\n* Participants previously exposed risankizumab\n* Participants who are currently participating in interventional research (not including noninterventional studies, post-marketing observational study (PMOS), or registry participation).",{"count":408,"type":20},200,"Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.\n\nRisankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately multiple sites across Germany and Austria.\n\nParticipants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.",[26],[60,61,412],"SKYRIZI","2026-06-16",{"date":374,"type":35},{"date":416,"type":35},"2025-02-27",{"date":418,"type":20},"2028-07",{"name":73,"class":74},56,{"id":422,"slug":4,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":427,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":53,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":43},"100555300","NCT06510296","Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease","DMBI","Inclusion Criteria:\n\n* age ≥ 18 years\n* self-identify as Black\u002FAfrican American and\u002For Hispanic\u002FLatino(a\u002Fx)\n* diagnosed with Crohn's disease or ulcerative colitis\n* ability to provide informed consent in English\n* elevated psychological distress: at least one T-score within 2.5 standard deviations above the mean -- NIH Toolbox Perceived Stress Scale or in the domains of either Anxiety or Depression on the NIH PROMIS-29.\n\nExclusion Criteria:\n\n* Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean.\n* Current suicidality, past suicide attempt, or psychiatric hospitalization.",true,{"count":114,"type":20},[116],"The bidirectional effects between psychological distress and inflammatory bowel disease (IBD) activity mean that not only does increased IBD activity trigger psychological distress, but psychological distress triggers increased IBD activity (i.e., gut-brain interaction). Comorbid psychological distress is linked to increased health resource utilization and poor health-related quality of life (HRQoL). This has prompted calls for integrating psychological care into IBD practice with restoration of quality of life as a clinical target of IBD management alongside endoscopic healing. The IBD Social Cognitive Model (IBD SCM) posits that patient psycho-behavioral modifiers contribute to IBD outcomes and not disease modifiers alone. While a co-localized gastro-psychologist in an IBD medical home is an emerging mode of delivering psycho-behavioral care among people living with IBD, access and scalability of this form of support is not yet widespread, particularly in resource-limited settings. Though many people with IBD have significant psychological distress, mental health care is underutilized with cost cited as a barrier.\n\nThe emergence of digital interventions in clinical practice presents an opportunity to address access, scalability, and cost barriers. However, current testing of digital interventions to address gut-brain interactions (digital mind-body intervention, DMBI) among people with IBD involves mostly women with high educational attainment who have full time employment and do not receive social service benefits. Individuals with limited resources and those from racial and ethnic minority groups (e.g. Black, Hispanic) often have socioecological factors, such as healthcare access and mental health stigma, that impede their use of psycho-behavioral resources. DMBI development informed by participatory research approaches are, therefore, critical to facilitate equitable engagement and utilization. Beneficial effects of psycho-behavioral treatment among people with IBD are strongest for those who have psychological distress and for acceptance, mindfulness, and values-based approaches.\n\nAlthough high quality evidence demonstrates psychological improvement with DMBI in IBD, feasibility and acceptability of applying DMBI to IBD patients from racial and ethnic minority groups is lacking.",[25,26,119],{"date":433,"type":35},"2026-06-17",{"date":435,"type":20},"2027-07",{"date":437,"type":20},"2028-09",{"name":439,"class":134},"Montefiore Medical Center",{"id":441,"slug":4,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":53,"phases":448,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":189},"100348403","NCT03816345","Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO","A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)","Inclusion Criteria:\n\n* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1\u002FPD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)\n\n  * Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer\n  * Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy\n* Patients who have previously received other forms of immunotherapy (high-dose \\[HD\\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks\n* Age \\>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \\>= 60)\n* Life expectancy of greater than 12 weeks\n* Leukocytes \\>= 1,000\u002FmcL\n* Absolute neutrophil count \\>= 500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5 x institutional ULN or =\\\u003C 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values\n* Creatinine ULN OR glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\n  * These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancy\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \\[CRFs\\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\\&R in press). Overlap features are permitted, but patients must meet criteria for a \"primary diagnosis\" of DM or SSc\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)\n* RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA\n* RA-SPECIFIC INCLUSION: Prednisone up to 10 mg\u002Fday will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints\n* RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed\n* SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatory\n* ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies\n* UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \\[Ag\\] negative, antibody \\[core (c)Ab\\] negative, antibody \\[surface (s)Ab\\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \\[PPD\\] or enzyme-linked immunospot assay \\[ELISpot or T-spot\\]) or be on appropriate anti-microbial treatment for these infections\n* UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplant\n* UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \\\u003C 2 on one of the medications or combination of medications defined for the Moderate or Mild cohort\n* CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy\u002Fvideo capsule endoscopy) and\u002For imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administration\n* CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required\n* CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infections\n* CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \\\u003C 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplant\n* CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \\\u003C 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \\\u003C 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12\u002F23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohort\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in question\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosis\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \\[CRP\\])\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalent\n* MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)\n* MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the study\n* SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalent\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and\u002For by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and\u002For biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or less\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients with prior therapy with an anti-PD-1 or anti-PD-L1\n* Patients with prior allogeneic hematologic transplant\n* Patients who are receiving any other anticancer investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* UC-SPECIFIC EXCLUSION: Prior colectomy\n* UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts\n* UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease\n* CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)",{"count":447,"type":20},300,[449],"PHASE1","This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and\u002For effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.",[452,120,453,454,24,455,456,457,458,459,460,461,462,26],"Autoimmune Disease","Dermatomyositis","Hematopoietic and Lymphoid Cell Neoplasm","Malignant Solid Neoplasm","Multiple Sclerosis","Psoriasis","Psoriatic Arthritis","Rheumatoid Arthritis","Sjogren Syndrome","Systemic Lupus Erythematosus","Systemic Scleroderma",{"date":433,"type":35},{"date":465,"type":35},"2019-07-16",{"date":467,"type":20},"2028-03-30",{"name":469,"class":42},"National Cancer Institute (NCI)",{"id":471,"slug":4,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":187,"enrollmentInfo":477,"targetDuration":4,"studyType":53,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":489},"100607249","NCT07186101","LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:","A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis","TOPAZ-UC","Inclusion Criteria:\n\n* Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC\n* Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1.\n* Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization\n* Are up-to-date on colorectal cancer surveillance per local society guidelines\n* Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:\n* Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)\n\nNOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US)\n\n* Advanced therapy-failed participants: Participants who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as:\n\n  * a biologic or biosimilar medication such as anti-tumor necrosis factor (anti-TNF) antibodies or anti-interleukin antibodies (IL-12\u002F23, or IL-23p19), except for\n\n    * mirikizumab.\n  * Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib\n  * sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod\n\nExclusion Criteria:\n\n* Have a current diagnosis of\n\n  * Crohn's disease\n  * Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery\n* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic\n* Have any adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed\n\nNote: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply\n\n* Have a current or recent acute, active infection",{"count":478,"type":20},252,[55],"The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).\n\nStudy participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.",[26],"2026-06-15",{"date":433,"type":35},{"date":485,"type":35},"2025-11-10",{"date":487,"type":20},"2029-03",{"name":332,"class":74},149,{"id":491,"slug":4,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":496,"targetDuration":4,"studyType":53,"phases":498,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":509},"100560017","NCT06571669","BOOM-IBD2 Pivotal Clinical Trial","BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.","Inclusion Criteria:\n\n* Male or female\n* 18 to 85 years of age\n* Diagnosed with ulcerative colitis\n* Ability and willingness to consent to participate by signing the informed consent form\n* Ability to comply with the protocol and willingness to comply with all follow up requirements\n\nExclusion Criteria:\n\n* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study\n* Any psychiatric or personality disorder at the discretion of the study investigator\n* Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)\n* Active clostridium difficile infection of the colon\n* Active cytomegalovirus (CMV) infection of the colon\n* Evidence of colonic perforation\n* Fulminant colitis requiring emergency surgery\n* Microscopic, ischemic or infectious colitis\n* Unresected neoplasia of the colon\n* Colonic stricture unable to pass a colonoscope\n* Current evidence of cancer in the gastrointestinal tract\n* Current participation in another clinical trial\n* Previous history of surgery for ulcerative colitis, or probably to require such intervention\n* Previously implanted with a neurostimulation device or participated in a neurostimulation trial\n* Inability to operate the patient programmer",{"count":497,"type":20},137,[116],"Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis. The investigational device sends mild signals to a nerve near the tailbone. It is placed during a same-day procedure.",[26,119],"2026-06-12",{"date":482,"type":35},{"date":504,"type":35},"2025-01-31",{"date":506,"type":20},"2027-11-30",{"name":508,"class":74},"Boomerang Medical",19,{"id":511,"slug":4,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":516,"minAge":4,"maxAge":4,"enrollmentInfo":517,"targetDuration":519,"studyType":21,"phases":4,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":529,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":43},"100512511","NCT05953402","A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring","ZEPOSIA® (Ozanimod) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring","Inclusion Criteria:\n\n* Currently or recently pregnant\n* Diagnosis of UC\n* Resident of country where ozanimod is prescribed for the treatment of UC\n\nExclusion Criteria:\n\n* Exposure to other S1P therapies at any time during pregnancy\n\nOther protocol-defined eligibility criteria apply.","FEMALE",{"count":518,"type":20},1182,"21 Months","The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.",[26],[523,524,525,526,24,527,26,528],"ZEPOSIA®","Ozanimod","Pregnancy","Sphingosine-1-phosphate (S1P) therapies","IBD","UC",{"date":482,"type":35},{"date":531,"type":35},"2026-04-21",{"date":533,"type":20},"2034-06-30",{"name":535,"class":74},"Bristol-Myers Squibb",{"id":537,"slug":4,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":15,"minAge":543,"maxAge":187,"enrollmentInfo":544,"targetDuration":4,"studyType":53,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":114},"100607165","NCT07185009","A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","SUNSCAPE-2","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \\\u003C18 years of age who meet the definition of Tanner stage 5 for development)\n* Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1\n* OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study\n\nExclusion Criteria:\n\n* Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator\n* Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","16 Years",{"count":545,"type":20},671,[258],"This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).\n\nStudy details include:\n\nThe study duration may be up to 286 weeks including:\n\n* 40-week Pivotal Maintenance Sub-Study\n* 240-week Open-Label Extension (OLE) Sub-Study\n* 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.\n\nThe treatment duration may be up to 280 weeks including:\n\n* 40 weeks in Pivotal Maintenance Sub-Study\n* 240 weeks in OLE Sub-Study\n\nThe total number of on-site visit will be up to 32:\n\n* 21 visits in the Pivotal Maintenance Sub-Study.\n* 11 visits in the OLE Sub-Study.",[26],"2026-06-11",{"date":501,"type":35},{"date":552,"type":35},"2026-01-16",{"date":554,"type":20},"2033-04-28",{"name":556,"class":74},"Sanofi",{"id":558,"slug":4,"hasResults":11,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":11,"sex":15,"minAge":564,"maxAge":16,"enrollmentInfo":565,"targetDuration":4,"studyType":53,"phases":566,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":572,"leadSponsor":574,"locationsCount":576},"100582600","NCT06865417","A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis","A Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Filgotinib, With Single Arm Induction and Maintenance, in Pediatric Subjects (8 to \u003C18 Years of Age) With Moderately to Severely Active Ulcerative Colitis","Galapeduca","Inclusion Criteria:\n\n* Subject must have a minimum body weight (BW) of 15 kg.\n* Subject:\n\n  * has documented diagnosis of UC with a minimum duration of 3 months,\n  * has mMCS of 5 to 9, and an MCS endoscopic score \\>=2, rectal bleeding \\>=1, and stool frequency \\>=1,\n  * has had an inadequate response, loss of response, intolerance, or has medical contraindications to corticosteroids, immunosuppressants, and\u002For biologic therapy. This includes subjects who depend on corticosteroids to control their symptoms and who experience worsening of their disease when attempting to wean off corticosteroids.\n\nExclusion Criteria:\n\n* Subject has a diagnosis of inflammatory bowel disease -unclassified or indeterminate colitis, isolated proctitis, or toxic megacolon.\n* Subject has an active infection.\n* Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement).\n* Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria).\n* Subject has a history of colectomy or extensive small bowel resection.\n* Subject with psychological or cognitive difficulties that might interfere with study participation.\n* Subject has any previous exposure to a Janus kinase inhibitor or medication with a similar mode of action (e.g. tofacitinib, baricitinib, upadacitinib).\n* Female subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.","8 Years",{"count":142,"type":20},[258],"The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years.\n\nApproximately 80 subjects from 8 to \\\u003C18 years of age with moderately to severely active UC, including a minimum of 8 subjects from 8 to \\\u003C12 years of age, will be enrolled in this study.\n\nDuring the study, eligible subjects will take the investigational product (IP) on-site at Week 4, Week 10, and Week 22 (in the morning; with or without food). On all other days, subjects will take IP at home (in the morning; with or without food).\n\nSubjects who do not achieve mMCS remission and\u002For MCS response at Week 10 will continue with induction treatment until Week 22. Subjects who do not achieve PUCAI remission at Week 22 will be permanently discontinued from the study.\n\nSubjects will all receive a filgotinib dose targeting the same systemic exposure as that observed in adults with UC treated with 200 mg q.d.",[26],"2026-06-10",{"date":501,"type":35},{"date":220,"type":35},{"date":573,"type":20},"2028-06",{"name":575,"class":74},"Alfasigma S.p.A.",47,""]