[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Saudi Arabia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":573},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,245,0,25,[9,41,63,86,110,134,154,175,200,226,249,271,299,327,336,357,379,409,432,451,475,497,516,534,553],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100054053",false,"NCT07223944","A Gaucher Disease Gene Therapy Trial With FLT201","A Phase 3 Safety and Efficacy Trial of FLT201 Gene Therapy in Patients With Gaucher Disease Type 1","GALILEO-3","Key Inclusion Criteria:\n\n* Aged ≥18 years at time of screening.\n* Clinical diagnosis of Gaucher disease type 1\n* Stable hemoglobin concentration at baseline\n* Stable platelet count at baseline\n* Receiving ERT or SRT without interruption for at least 2 years\n\nKey Exclusion Criteria:\n\n* Diagnosed or suspected Gaucher disease type 2 or type 3\n* Positive for AAVS3 neutralizing antibodies.\n* Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study\n* Positive pregnancy test or lactating\n* History of hematopoietic stem cell transplant (HSCT)\u002Fbone marrow transplant or any solid organ transplant.\n* History of receiving any gene therapy or cell therapy.\n* History of total splenectomy. Note: Additional protocol defined Inclusion and Exclusion criteria apply","ALL","18 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is a Phase 3, non-randomized, multicenter, efficacy and safety study in adult patients with Gaucher disease Type 1, on stable treatment with enzyme replacement therapy (ERT) or substrate reduction therapy (SRT) for at least 2 years. The study aims to confirm the efficacy and safety of FLT201 in this population after discontinuation of ERT\u002FSRT.",[27],"Gaucher Disease Type 1","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2026-04-07",{"date":36,"type":21},"2032-10-01",{"name":38,"class":39},"Spur Therapeutics","INDUSTRY",33,{"id":42,"slug":4,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":62},"100053921","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of CD at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.","16 Years","80 Years",{"count":50,"type":21},1200,[24],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[54],"Crohn's Disease",{"date":31,"type":32},{"date":57,"type":32},"2024-06-05",{"date":59,"type":21},"2029-11-12",{"name":61,"class":39},"Merck Sharp & Dohme LLC",499,{"id":64,"slug":4,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100053407","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days","17 Years",{"count":72,"type":21},342,[74,24],"PHASE2","This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[77,78],"Heart Failure","Left Ventricular Systolic Dysfunction",{"date":31,"type":32},{"date":81,"type":32},"2023-05-31",{"date":83,"type":21},"2032-04-15",{"name":61,"class":39},107,{"id":87,"slug":4,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100534614","NCT06241118","A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor","A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment","AQUA","Inclusion Criteria:\n\n* Participants must be 12 years of age (when signing informed consent form)\n* Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)\n* Documented history prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.\n* v-IGA-AD of 3 or 4 at baseline visit\n* EASI score of 16 or higher at baseline\n* AD involvement of 10% or more of BSA at baseline\n* Weekly average of daily PP-NRS of ≥ 4 at baseline visit.\n* Able and willing to comply with requested study visits and procedures\n* Body weight ≥25 kg\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Skin co-morbidity that would adversely affect the ability to undertake AD assessments\n* Known history of or suspected significant current immunosuppression\n* Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured \\>5 years prior to baseline)\n* History of solid organ or stem cell transplant\n* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline\n* Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit\n* Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB\n* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit\n* In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening\n* History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial","12 Years",{"count":95,"type":21},636,[24],"This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy.\n\nThe purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy.\n\nStudy details include:\n\nAt the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD).\n\nThe study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \\[RIVER-AD\\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up.\n\nThe study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \\[RIVER-AD\\]) including a 2 to 4-week screening and a 36-week randomized double-blind period.\n\nThe total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \\[RIVER-AD\\] study).",[99],"Dermatitis Atopic","2026-07-01",{"date":102,"type":32},"2026-07-02",{"date":104,"type":32},"2024-02-29",{"date":106,"type":21},"2028-09-29",{"name":108,"class":39},"Sanofi",150,{"id":111,"slug":4,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100634559","NCT07541261","A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia","A Multi-Center, Non-Interventional Study on Effectiveness and Treatment Persistence of Guselkumab in Patients With ULcerative Colitis and Crohn's DiseasE in Real-World Practice in Saudi Arabia","EAGLE","Inclusion Criteria:\n\n* The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent\n* The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records\n* The participant must sign a participation agreement\u002Finformed consent form (ICF) allowing source data verification\n\nExclusion criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to Interleukin (IL)-23 inhibitors, including tremfya (guselkumab), skyrizi (risankizumab) and omvoh (mirikizumab). As an exception, participants with history of ustekinumab exposure may be included\n* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and\u002For small molecules)\n* Is unable to provide informed consent",{"count":118,"type":21},100,"OBSERVATIONAL","The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.",[122,123,124],"Colitis","Ulcerative","Crohn Disease","2026-06-30",{"date":102,"type":32},{"date":128,"type":32},"2026-05-12",{"date":130,"type":21},"2029-01-29",{"name":132,"class":39},"Janssen Research & Development, LLC",1,{"id":135,"slug":4,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100498916","NCT05776472","A Real World Effectiveness Study of Pegcetacoplan in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","A Single Arm, Long-term, Multicentre Observational Study to Evaluate Effectiveness of Pegcetacoplan Under Real World Conditions in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","COMPLETE","Inclusion Criteria:\n\n* Patients ≥18 years of age with a documented PNH diagnosis.\n* Patient started routine treatment with pegcetacoplan for PNH up to 12 months before enrollment or prescribed pegcetacoplan at enrollment. Decision to initiate treatment shall be made by the treating physician and independently from the decision to include the patient in the study.\n* Patient is willing and able to provide written informed consent to participate in the study in a manner approved by the Institutional Review Board\u002FIndependent Ethics Committee and local regulations.\n\nExclusion Criteria:\n\n* Enrollment in a concurrent clinical interventional study, or intake of an Investigational Medicinal Product (IMP), within three months prior to the start of the current pegcetacoplan treatment.\n* Initiated current treatment with pegcetacoplan in an interventional study.",{"count":142,"type":21},200,"This is a 36-month, long-term, multicenter, observational study designed to describe the real world effectiveness of pegcetacoplan in patients with PNH. Patients meeting the eligibility criteria will be enrolled in the study and followed prospectively for approximately 36 months. Patient data will be collected from start of pegcetacoplan treatment to end of follow-up. Retrospective data on pegcetacoplan will be captured from the time of pegcetacoplan treatment initiation. Pegcetacoplan treatment data will be collected for a minimum of approximately 36 months and up to a maximum of approximately 72 months, including retrospective period depending on when the patient started pegcetacoplan treatment. After pegcetacoplan treatment discontinuation, patients will remain in the study for 8 weeks to capture any AEs. The scope of the study is to collect both retrospective and prospective data. Baseline is defined as start of pegcetacoplan treatment. The main part of the study will be prospective,collecting data on effectiveness, safety (all AEs), patient- and clinician-reported outcomes and health care resource use.",[145],"Paroxysmal Nocturnal Hemoglobinuria",{"date":100,"type":32},{"date":148,"type":32},"2023-06-26",{"date":150,"type":21},"2029-08-21",{"name":152,"class":39},"Swedish Orphan Biovitrum",87,{"id":155,"slug":4,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100607564","NCT07190196","A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease","A Randomized, Phase 3, Double-blind, 52-week Study to Evaluate the Efficacy and Safety of Rilzabrutinib (SAR444671) Compared to Placebo in Adult Participants With Active IgG4-related Disease","RILIEF","Inclusion Criteria:\n\n* Participants must have an adjudicated clinical diagnosis of IgG4-RD\n* Participants meeting Step 1 Entry criteria of 2019 ACR\u002FEULAR classification criteria for IgG4-RD and Total inclusion points are ≥20\n* Participants with active disease at screening in at least one organ system, excluding lymph nodes, as an IgG4-RD Responder Index total activity score ≥ 2\n* Participants with history or current involvement of at least 1 organ\u002Fsite (excluding lymph nodes) affected with IgG4-RD.\n* Participants with active IgG4-RD controlled for at least 2 weeks while on a stable dose of GC.\n* Participants willing to taper off GC after starting IMP.\n* Participants willing and able to participate in repeated study protocol mandated or clinically indicated imaging procedures to assess IgG4-RD such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), or ultrasound.\n* Participants who have an up-to-date vaccination status as per local guidelines. The last dose of live vaccines should be received at least 30 days before Day 1.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Meet any Step 2 Exclusion criteria from the 2019 ACR\u002FEULAR classification criteria for IgG4-RD.\n* History of retroperitoneal fibrosis, sclerosing mesenteritis, fibrosing mediastinitis, or other overwhelmingly fibrotic expression of IgG4-RD that is the sole disease manifestation.\n* Active malignancy or history of malignancy within 5 years before Day 1, except completely treated in situ carcinoma of the cervix, completely treated, and resolved nonmetastatic squamous or basal cell carcinoma of the skin.\n* Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator.\n* History of serious infections with the potential for recurrence (as judged by the Investigator), with less than 4 weeks interval between resolution of serious infection and first dose of study drug, or currently active moderate to severe infection at Screening (Grade 2 or higher).\n* Current or chronic history of liver disease unrelated to IgG4-RD.\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, bariatric surgery, or significant bowel resection that would preclude adequate rilzabrutinib\u002Fplacebo absorption.\n* History of solid organ transplant.\n* Planned major surgical procedure during the participation in this study.\n* History of drug abuse within the previous 12 months.\n* Alcoholism or excessive alcohol use, defined as regular consumption of more than approximately 3 standard drinks per day.\n* Prior participation in any rilzabrutinib studies or other BTK inhibitor studies.\n* History of treatment with an investigational drug within 6 months or 5 half-lives of the investigational drug, whichever is longer.\n* Laboratory abnormalities at the screening visit identified by the central laboratory The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":162,"type":21},124,[24],"This is a Phase 3, parallel group, 2-arm, randomized, double blind, placebo-controlled, 52-week treatment study to assess the efficacy and safety of rilzabrutinib as a treatment for adult patients with active IgG4-RD.\n\nThe purpose of this study is to measure time to IgG4-RD clinical disease flare, and other relevant efficacy endpoints including flare-free rate, control of IgG4-RD disease activity, use of GC rescue and safety parameters such as treatment-emergent adverse events, clinical laboratory values and electrocardiograms (ECG) in participants aged 18 years and above, diagnosed with IgG4-RD and treated with rilzabrutinib tablets over a 52-week placebo-controlled period.\n\nStudy details include:\n\nThe study duration will be up to 60 weeks, including a 4 to 6-week screening period, a 52-week double blind treatment period, and 2 weeks of follow up (plus an optional OLE of 108 weeks).\n\nThe number of visits will be 16 (plus an optional 9 visits during the OLE).",[166],"Immunoglobulin G4 Related Disease","2026-06-29",{"date":100,"type":32},{"date":170,"type":32},"2025-09-26",{"date":172,"type":21},"2030-12-25",{"name":108,"class":39},79,{"id":176,"slug":4,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100540241","NCT06314282","INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use","INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice","INTERSTELLAR","Inclusion Criteria:\n\n1. Aged 18 years or older at study enrolment.\n2. Fulfilled the 2019 EULAR\u002FACR criteria1 for SLE at the time of study entry.\n3. Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.\n4. It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion.\n5. In countries where prescription reimbursements are authorized on a case-by-case basis, authorization (ie, patient access to treatment) will be required for study entry.\n6. Provided informed consent to participate in the study.\n7. Willing and able to participate in all required study evaluations and procedures.\n\nExclusion Criteria:\n\n1. Currently participating in an anifrolumab early access\u002Fcompassionate use program or an interventional clinical trial with an investigational product.\n2. Previous exposure to anifrolumab as part of a clinical trial or early access program.\n3. Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \\[MMF\\]\u002Fcyclophosphamide \\[CYC\\] + high dose steroids), isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus.\n4. Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.",{"count":142,"type":21},"INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion\u002Fexclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study.",[185],"Systemic Lupus Erythematosus (SLE)",[187,188,189,190,191],"SLE","Systemic lupus erythematosus","autoimmune disease","Lupus","Anifrolumab",{"date":125,"type":32},{"date":194,"type":32},"2024-10-22",{"date":196,"type":21},"2027-12-31",{"name":198,"class":39},"AstraZeneca",32,{"id":201,"slug":4,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":207,"maxAge":48,"enrollmentInfo":208,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},"100598310","NCT07069829","Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri\u002FTrixeo","Real-world, International, Multicentre, Non-interventional, Prospective Cohort to Assess Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri\u002FTrixeo in Routine Care Settings","iCHOROS","Inclusion Criteria:\n\nThe study will include patients who were prescribed BGF, but not yet initiated, according to the label (SmPC) and local market reimbursement criteria. Patients will only be included in the study if they meet the following inclusion criteria:\n\n1. Patients diagnosed with COPD, at least 12 months before baseline, as assessed per physician's routine practice or as documented in the patient's chart.\n2. Male or female patients aged over 30 years and under 80 years at the time of enrolment.\n3. Patients providing a written Informed Consent\\* prior to inclusion to the study.\n\n   \\*Prescription of BGF should be prior to the signed informed consent and the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study.\n4. Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will not be eligible to participate in the study:\n\n1. Patients with COPD due to documented α-1 antitrypsin deficiency.\n2. Patients with recent (≤3 months) major cardiac or pulmonary events that required hospitalization (e.g., myocardial infarction, pulmonary embolism).\n3. Patients previously treated with triple fixed-dose combination therapies 12 months before the screening visit or treated with Multiple Inhaled Triple Therapy (MITT) within the last 3 months before the screening visit.\n4. Patients hospitalized due to COPD exacerbations within the last 30 days prior to enrolment.\n5. Currently pregnant (or intending to become pregnant), breastfeeding, or lactating women.\n6. Patients with a current diagnosis of asthma, active tuberculosis, lung cancer or lung metastasis, significant bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active clinically significant pulmonary diseases.\n7. Patients currently participating in a non-interventional observational trial that might, in the investigator's opinion, influence the assessment for the current study or participation in any interventional trial in the last 30 days prior to enrolment.\n8. Patients with respiratory tract infection (including COVID-19 infection) ) that has not resolved ≤30 days prior to BGF MDI initiation and those exhibiting persistent long-COVID symptoms are excluded from the study.","30 Years",{"count":209,"type":21},1400,"Chronic Obstructive Pulmonary Disease is a leading cause of global morbidity and mortality, especially in low- and middle-income countries. Exacerbations accelerate disease progression and increase the risk of death. Recent recommendations from the GOLD report emphasize the diagnosis of COPD and treatment planning based on a combination of lung function metrics, exacerbation history, and patient-reported symptoms. It is recommending the use of triple combination therapy (ICS+LABA+LAMA) such as BREZTRI\u002FTRIXEO as one of the options in Group E patients. While BGF has demonstrated efficacy in controlled clinical trials, real-world evidence is needed to assess its impact on daily patient outcomes and quality of life.\n\nThe iCHOROS study is a real-world, international, multicenter, observational study aiming to evaluate changes in clinical and patient-reported outcomes in adults with moderate to severe COPD treated with BGF for 12 months in routine care settings across Latin America, Asia, and the Middle East \\& Africa. The study will provide valuable insights into the effectiveness and patient experience of BGF therapy in diverse, real-world populations",[212],"Chronic Obstructive Pulmonary Disease",[214,215,216,217],"COPD","Moderate to Severe Chronic Obstructive Pulmonary Disease","Severe Exacerbations","BGF - Budesonide\u002FGlycopyrrolate\u002FFormoterol Fumarate","2026-06-26",{"date":167,"type":32},{"date":221,"type":32},"2025-12-15",{"date":223,"type":21},"2027-09-30",{"name":198,"class":39},36,{"id":227,"slug":4,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":248},"100422855","NCT04786262","A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes","A Phase 1\u002F2\u002F3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia","Key Inclusion Criteria:\n\n* Clinical history of T1D with \\> 5 years of duration of insulin dependence\n* At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment\n* Stable diabetic treatment\n* Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study\n\nKey Exclusion Criteria:\n\n-Prior islet cell transplant, organ transplant, or cell therapy\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply","65 Years",{"count":234,"type":21},52,[24],"This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.",[238,239,240],"Diabetes Mellitus, Type 1","Impaired Hypoglycemic Awareness","Severe Hypoglycemia",{"date":125,"type":32},{"date":243,"type":32},"2021-03-29",{"date":245,"type":21},"2030-06-30",{"name":247,"class":39},"Vertex Pharmaceuticals Incorporated",29,{"id":250,"slug":4,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100583779","NCT06880770","Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis","Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)","SHASTA-5","Inclusion Criteria:\n\n* Males, or nonpregnant (who do not plan to become pregnant) nonlactating females\n* Established diagnosis of SHTG and prior documented evidence of fasting TG levels of ≥ 880 mg\u002FdL (≥ 10 mmol\u002FL)\n* Documented evidence of at least 1 prior AP event not attributed to other etiologies occurring within the last 60 months prior to Screening.\n* Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg\u002FdL (≤ 3.37 mmol\u002FL) at Screening\n* Screening hemoglobin A1c (HbA1c) ≤ 9.5%\n* Willing to follow diet counseling and maintain a stable low-fat diet\n* Must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant, or a treatment failure as determined by the Investigator)\n\nExclusion Criteria:\n\n* Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and\u002For triglycerides within 365 days before Day 1, except inclisiran.\n* Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives lives before day 1. Whichever is longer.\n* AP ≤ 4 weeks prior to Randomization\u002FDay 1\n* Body mass index (BMI) \\> 45 kg\u002Fm\\^2\n* Any planned bariatric surgery or similar procedures to induce weight lost starting at consent through End of Study (EOS)\n* Planned coronary intervention (e.g. stent placement or heart bypass) during the study\n* History of arterial revascularization within 16 weeks of Screening\n* History of acute coronary syndrome event within 24 weeks of Screening\n* Recent atherosclerotic cardiovascular disease (ASCVD) event within 24 weeks of Screening\n* Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days of Screening. Individuals with stable well-controlled atrial arrhythmia will be allowed to participate in the study\n* History of pacemaker or automatic implantable cardioverter defibrillators implant within 30 days before Screening\n* New York Heart Association Class III-IV heart failure or last known ejection fraction of \\\u003C 30%\n* Current diagnosis of nephrotic syndrome\n* Chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) \\\u003C 20 mL\u002Fmin\u002F1.73 m\\^2\n* Liver disease defined as cirrhosis or Child-Pugh Class B and C, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2.5× Upper Limit of Normal (ULN) at Screening\n\nNote: Additional Inclusion\u002FExclusion Criteria may apply per protocol",{"count":257,"type":21},288,[24],"This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.",[261],"Severe Hypertriglyceridemia","2026-06-25",{"date":218,"type":32},{"date":265,"type":32},"2025-04-24",{"date":267,"type":21},"2029-06",{"name":269,"class":39},"Arrowhead Pharmaceuticals",95,{"id":272,"slug":4,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":284,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":298},"100573164","NCT06742723","A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure","A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure","BaxDuo-Pacific","Inclusion Criteria:\n\n1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.\n2. Participants with (a) or (b):\n\n   a) eGFR 30-59 mL\u002Fmin\u002F1.73 m² (local or central laboratory value) AND:\n   * UACR ≥ 30 mg\u002Fg (3.39 mg\u002Fmmol) and \\\u003C 500 mg\u002Fg (56.5 mg\u002Fmmol) (central laboratory value only), or\n   * UACR ≥ 500 mg\u002Fg (56.5 mg\u002Fmmol) and ≤ 5000 mg\u002Fg (565 mg\u002Fmmol) (local or central laboratory value), or\n   * UPCR ≥ 700 mg\u002Fg (79 mg\u002Fmmol) and ≤ 7000 mg\u002Fg (790 mg\u002Fmmol) (local laboratory value only).\n\n     (b) eGFR 60-75 mL\u002Fmin\u002F1.73 m² (local or central laboratory value) AND:\n   * UACR ≥ 500 mg\u002Fg (56.5 mg\u002Fmmol) ) and ≤ 5000 mg\u002Fg (565 mg\u002Fmmol) (local or central laboratory value), or\n   * UPCR ≥ 700 mg\u002Fg (79 mg\u002Fmmol) and ≤ 7000 mg\u002Fg (790 mg\u002Fmmol) (local laboratory value only)\n3. \\[obsolete\\]\n4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.\n5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.\n6. Participants with:\n\n   1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol\u002FL if eGFR ≥ 45 mL\u002Fmin\u002F1.73 m2 (local or central laboratory values)\n   2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol\u002FL if eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2 (local or central laboratory values)\n\nExclusion Criteria:\n\n1. Systolic blood pressure \\> 180 mmHg, or diastolic BP \\> 110 mmHg at screening.\n2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol\u002FL within 3 months at screening.\n3. Serum sodium \\\u003C 135 mmol\u002FL (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).\n\n4\\. Participants with T1DM will be excluded, except:\n\n1. For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.\n2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.\n\n   5 Uncontrolled T2DM with HbA1c \\> 10.5% (\\> 91 mmol\u002Fmol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).\n\n   6 New York Heart Association functional HF class IV at screening.\n\n   7 Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.\n\n   8 Documented history of adrenal insufficiency.\n\n   9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.\n\n   10 Any acute kidney injury within 3 months prior to the Screening Visit.\n\n   11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).\n\n   12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).",{"count":279,"type":21},5000,[24],"International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure",[283],"Chronic Kidney Disease and Hypertension",[285,286,287,288,289,290,291],"Chronic kidney disease","Hypertension","Blood pressure","Baxdrostat","Dapagliflozin","Event-Driven","Outcome",{"date":218,"type":32},{"date":294,"type":32},"2025-03-03",{"date":296,"type":21},"2029-12-18",{"name":198,"class":39},764,{"id":300,"slug":4,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":326},"100563385","NCT06615479","A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2)","A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma","Inclusion Criteria\n\n* Participants must have relapsed or refractory multiple myeloma (RRMM).\n* Participants must have received at least 1 but no greater than 3 prior multiple myeloma (MM) regimens which may include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody and have prior exposure to lenalidomide.\n* Participants must have a documented diagnosis of MM as per International Myeloma Working Group Criteria.\n* Participants must have measurable disease during screening.\n* Participants must have adequate organ function.\n* Participants must have an Eastern Cooperative Oncology group performance status 0 or 1.\n\nExclusion Criteria\n\n* Participants must not have known active or history of central nervous system (CNS) involvement of Multiple Myeloma (MM).\n* Participants must not have solitary plasmacytomas or non-secretory myeloma without other evidence of measurable disease.\n* Participants must not need urgent treatment due to rapidly progressing MM.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":306,"type":21},440,[24],"The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.",[310],"Relapsed or Refractory Multiple Myeloma (RRMM)",[312,313,314,315,316,317,318],"Relapsed or Refractory Multiple Myeloma","Multiple Myeloma","BMS-986393","Chimeric Antigen Receptor T-cell (CAR T-cell)","CAR T-cell Therapy","Arlocabtagene Autoleucel","Arlo-cel",{"date":218,"type":32},{"date":321,"type":32},"2025-03-12",{"date":323,"type":21},"2032-06-22",{"name":325,"class":39},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company",140,{"id":328,"slug":4,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":52,"conditions":331,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":334,"leadSponsor":335,"locationsCount":62},"100549191",{"count":50,"type":21},[24],[54],{"date":167,"type":32},{"date":57,"type":32},{"date":59,"type":21},{"name":61,"class":39},{"id":337,"slug":4,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":343,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":356},"100539731","NCT06307652","Study to Evaluate the Effect of Balcinrenone\u002FDapagliflozin in Patients With Heart Failure and Impaired Kidney Function","A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone\u002FDapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function","BalanceD-HF","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Documented diagnosis of symptomatic HF (NYHA functional class II-IV)\n* Having had a recent HF event within 6 months (hospitalization or urgent visit)\n* Have a LVEF value from an assessment within the last 12 months\n* Managed with SoC therapy for HF and renal impairment according to local guidelines\n* NT-proBNP must be \\>300 pg\u002FmL (\\>600 pg\u002FmL if concomitant atrial fibrillation or atrial flutter)\n* Not taking an MRA\n* An eGFR ≥ 20 to \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n* Serum\u002Fplasma potassium ≤ 5.0 mmol\u002FL\n\nExclusion Criteria:\n\n* Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period\n* Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations\n* History of hypertrophic obstructive cardiomyopathy\n* Complex congenital heart disease or severe uncorrected primary valvular disease\n* Symptomatic bradycardia or second- or third-degree heart block without a pacemaker\n* Systolic BP \\\u003C 90 mmHg, or symptomatic hypotension within the past 24 hours\n* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment\n* Type 1 diabetes mellitus\n* Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy\n* Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy\n* Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks\n* Treatment with strong or moderate CYP3A4 inhibitor or inducer","130 Years",{"count":345,"type":21},4800,[24],"This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone\u002Fdapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.",[349],"Heart Failure and Impaired Kidney Function",{"date":218,"type":32},{"date":352,"type":32},"2024-04-12",{"date":354,"type":21},"2027-06-11",{"name":198,"class":39},852,{"id":358,"slug":4,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":378},"100491907","NCT05685238","A Research Study Looking at Long-term Treatment With Mim8 in People With Haemophilia A","Open-label, Long-term Safety and Efficacy Study of Mim8 in Participants With Haemophilia A With or Without Inhibitors","FRONTIER4","Arm 1 \\& 2:\n\nInclusion Criteria:\n\n1. Informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.\n2. Male or female with diagnosis of congenital haemophilia A based on medical records.\n3. Ongoing participation in study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728 at the time of transfer. Participant should qualify either of the following criteria:\n\n   1. Participant from study NN7769-4513, who has participated in the extension part of the study for at least 12 weeks prior to enrolment in study NN7769-4532, or,\n   2. Participant has completed the end of treatment visit for study NN7769-4514, NN7769-4516 or NN7769-4728.\n4. Participant and\u002For participant's parent(s)\u002Fparticipant's Legally acceptable representative (LAR) willingness and ability to comply with scheduled visits and study procedures, including the completion of diary.\n\nExclusion Criteria:\n\n1. Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n2. Participant who has discontinued or been withdrawn from studies NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728.\n3. Previous participation in this study. Participation is defined as signed informed consent.\n4. Female who is pregnant, breast-feeding or intends to become pregnant.\n5. Female of child-bearing potential and not using a highly effective contraceptive method (highly effective contraceptive measures or as required by local regulation or practice).\n6. Participation (i.e., signed informed consent) in any interventional, clinical study (except from study NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728) of an approved or non-approved investigational medicinal product.\n7. Any planned major surgery, during part 1 of the study.\n8. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.\n\nArm 3:\n\nInclusion criteria\n\n1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.\n2. Male or female with diagnosis of congenital severe haemophilia A (endogenous FVIII activity less than (\\\u003C) 1 percentage \\[%\\]) with or without FVIII inhibitors based on medical records.\n3. Aged \\\u003C1 year at the time of signing informed consent.\n4. Body weight greater than or equal to (≥) 3.2 kilograms at the time of signing informed consent.\n5. previously untreated patients (PUPs) or minimally treated patients (MTPs) (i.e., up to 5 days of exposure to haemophilia-related treatment such as plasma-derived FVIII, recombinant FVIII, fresh frozen plasma, cryoprecipitate, or whole blood products).\n6. Full-term pregnancy (gestational age ≥37 weeks).\n7. Participant's parent(s)\u002FLAR(s) willingness and ability to comply with scheduled visits and Arm 3 (infant) procedures, including the completion of diary and patient reported outcome (PRO) questionnaire.\n8. Participants \\\u003C3 months of age must show no signs of active intracranial haemorrhage at screening. This is confirmed by cranial ultrasound performed according to local practice and regardless of delivery method.\n9. Receipt of vitamin K prophylaxis (as per local standard practice).\n10. Availability of historical results in medical records for:\n\n    1. activated partial thromboplastin time (aPTT)\n    2. FVIII levels.\n11. Availability of historical results in medical records or pre-dose sample taken for:\n\n    1. fibrinogen\n    2. haematology parameters\n    3. biochemistry parameters (aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT), bilirubin and creatinine).\n\nExclusion criteria\n\n1. Known or suspected hypersensitivity to trial product or related products.\n2. Previous participation in study 4532. Participation is defined as signed informed consent.\n3. Participation (i.e., signed informed consent) in any interventional clinical study with receipt of the last dose within 6 months (or 5 half-lives of the investigational medicinal product, whichever is shorter) before planned enrolment.\n4. Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) before planned enrolment.\n5. Known congenital or acquired coagulation disorders other than haemophilia A.\n6. Other conditions (e.g., autoimmune disease) or laboratory abnormality that may increase the risk of bleeding or thrombosis, as evaluated by the investigator. Any disorder, except for conditions associated with haemophilia A, that in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.\n7. Lack of adequate parental\u002Flegally acceptable representative (LAR) support to enter accurately and timely information regarding treatment and bleeding episodes into an (electronic) diary.\n8. Previous or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease.\n9. Any planned major surgery, during part 1 of Arm 3 (infant). For definition of major surgery.\n10. Immune tolerance induction planned to take place after treatment initiation.\n11. Hepatic dysfunction defined as AST and\u002For ALT greater than (\\>) 3 times the upper limit of normal (ULN) combined with total bilirubin \\>1.5 times the ULN.\n12. Serum creatinine above 1.5 times the ULN.",{"count":365,"type":21},451,[24],"This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). The study will last for up to 5.5 years. The duration of the study depends on when the participant enrolled in this study. The study will end if Mim8 is approved and marketed in participant's country during the study, or the study will end in June 2028, whichever comes first. Participants will get up to 262 injections; the number of injections depends on how often participants will get injections and how long time participants take part in the study. While taking part in this study, there are some restrictions about what medicine participants can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.",[369,370],"Haemophilia A","Haemophilia A With Inhibitors",{"date":125,"type":32},{"date":373,"type":32},"2023-02-13",{"date":375,"type":21},"2028-06-30",{"name":377,"class":39},"Novo Nordisk A\u002FS",152,{"id":380,"slug":4,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":22,"phases":389,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":400,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":404,"leadSponsor":406,"locationsCount":133},"100644835","NCT07677189","Sensorimotor Balance Training for Chronic Nonspecific Low Back Pain","Effects of Sensorimotor Balance Training on Pain and Spinal Alignment in Adults With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial","SENSOR-LBP","Inclusion Criteria:\n\n* Adults aged 18 to 59 years. Diagnosis of chronic nonspecific low back pain lasting at least 3 months. Pain intensity score of 4 or greater on the Numeric Pain Rating Scale (NPRS). Body Mass Index (BMI) between 25 and 35 kg\u002Fm². Ability to safely participate in the exercise program and comply with study procedures.\n\nExclusion Criteria:\n\n* Acute low back injury. History of spinal surgery. Neurological disorders affecting movement or balance. Musculoskeletal disorders affecting movement or balance. Professional athletes. Individuals engaged in heavy manual labor. Any medical condition that would prevent safe participation in the intervention program.","59 Years",{"count":388,"type":21},80,[390],"NA","Chronic nonspecific low back pain is one of the most common causes of pain and disability worldwide. Many people with chronic low back pain experience difficulties with balance, posture, movement control, and daily activities. Sensorimotor balance training is a rehabilitation approach designed to improve balance, body awareness, and neuromuscular control.\n\nThe purpose of this randomized controlled trial is to investigate whether sensorimotor balance training is more effective than standard physiotherapy in reducing pain and improving spinal alignment in adults with chronic nonspecific low back pain. Participants will be randomly assigned to either a sensorimotor balance training group or a standard physiotherapy group. Both groups will receive treatment three times per week for 12 weeks.\n\nPain intensity, functional disability, and spinal alignment will be assessed before and after the intervention. Spinal alignment will be measured using the DIERS Formetric 4D system, a non-invasive and radiation-free technology that evaluates posture and spinal shape. The findings of this study may help identify effective rehabilitation strategies for improving pain, function, and spinal alignment in people with chronic nonspecific low back pain.",[393],"Chronic Nonspecific Low Back Pain",[393,395,396,397,398,399],"Sensorimotor Balance Training","Neuromuscular Control","Spinal Alignment","Physiotherapy","Rehabilitation","NOT_YET_RECRUITING","2026-06-24",{"date":125,"type":32},{"date":100,"type":21},{"date":405,"type":21},"2027-03-01",{"name":407,"class":408},"Najran University","OTHER",{"id":410,"slug":4,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":416,"minAge":417,"maxAge":418,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},"100614889","NCT07285460","A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B","An Open-label, Parallel, Phase 3, Two-arm Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B With or Without Inhibitory Antibodies to Factors VIII or IX","ATLAS-KIDS","Inclusion Criteria:\n\nParticipants not previously exposed to fitusiran are eligible to be included in the study only if all of the following criteria apply:\n\n* Participant must be 1 to \\\u003C12 years of age at the time of enrollment.\n* Participants must have severe hemophilia A or B (FVIII \\\u003C1% or FIX ≤2%) as evidenced by a central laboratory measurement at screening or documented medical record evidence.\n* Participants must meet inhibitor or non-inhibitor status as defined below:\n\nInhibitor:\n\nRequiring use of BPA for prophylaxis or BPA as on-demand therapy for any bleeding episodes for at least the last 3 months prior to screening, and meet one of the following Nijmegen-modified Bethesda assay results criteria:\n\n* Inhibitor titer of ≥0.6 BU\u002FmL at screening, OR\n* Inhibitor titer of \\\u003C0.6 BU\u002FmL at screening with medical record evidence of 2 consecutive titers ≥0.6 BU\u002FmL, OR\n* Inhibitor titer of \\\u003C0.6 BU\u002FmL at screening with medical record evidence of 1 inhibitor titer ≥0.6 BU\u002FmL and a history of anamnestic response, or severe allergic reaction (eg, anaphylaxis) or nephrotic syndrome\n\nNon-inhibitor:\n\nRequiring use of clotting factor concentrates (CFCs) for prophylaxis or CFCs as on-demand therapy for any bleeding episodes for at least the last 3 months prior to screening, and meet each of the following criterion:\n\n* Nijmegen-modified Bethesda assay inhibitor titer of \\\u003C0.6 BU\u002FmL at screening, AND\n* No use of BPA to treat bleeding episodes for at least the last 3 months prior to screening\n\n  * Participants must have adequate peripheral venous access, as determined by the Investigator, to allow the blood draws required by the study protocol.\n  * Male: There are no contraceptive requirements for this study except where required by local regulations.\n  * Capable of giving signed informed consent\u002Fassent. A signed written informed consent must be obtained from parent(s)\u002Flegal guardian (hereafter referred to as the \"parent\"), as well as a written or oral assent obtained from participant, per local and national requirements.\n\nExclusion Criteria:\n\nParticipants not previously exposed to fitusiran are excluded from the study if any of the following criteria apply:\n\n* Known co-existing bleeding disorders other than hemophilia A or B.\n* Presence of clinically significant liver disease.\n* History of antiphospholipid antibody syndrome.\n* History of arterial or venous thromboembolism, unrelated to an indwelling venous access\n* Any condition (eg, medical concern), which in the opinion of the Investigator, would make the participant unsuitable for dosing or which could interfere with the study compliance, the participant's safety and\u002For the participant's participation in the completion of the treatment period of the study.\n* History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc.\n* Subjects with a central or peripheral indwelling catheter, with a history of venous access complications (such as infections, thrombosis) leading to hospitalization and\u002For systemic anticoagulation therapy in the last 12 months.\n* At screening, anticipated need of surgery during the study or planned surgery scheduled to occur during the study.\n* Completion of a surgical procedure within 14 days prior to screening, or currently receiving additional BPA infusion for postoperative hemostasis.\n* History of intolerance to SC injection(s).\n* Current participation in ITI therapy.\n* The use of emicizumab (Hemlibra®) or any non-factor bleed management treatment within 6 months prior to screening\n* Prior gene therapy\n* Current or future participation in another clinical study, scheduled to occur during this study, involving an investigational product other than fitusiran or an investigational device.\n* AT activity \\\u003C60% at screening, as determined by central laboratory analysis.\n* Co-existing thrombophilic disorder.\n* Presence of an active Hepatitis C virus infection\n* Presence of acute hepatitis A or Hepatitis E virus infection.\n* Presence of acute or chronic hepatitis B virus infection.\n* Platelet count ≤100 000\u002FμL.\n* Presence of acute infection at screening.\n* Human immunodeficiency virus (HIV) positive with a CD4 count of \\\u003C400 cells\u002FμL.\n* Estimated glomerular filtration rate ≤45 mL\u002Fmin\u002F1.73 m2 (using the Schwartz formula).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","MALE","1 Year","11 Years",{"count":420,"type":21},85,[24],"This is a parallel, Phase 3, two-arm, open-label study to evaluate the efficacy and safety of treatment with fitusiran prophylaxis administered to male pediatric participants (aged 1 to \\\u003C12 years) who have severe hemophilia A or B, with or without inhibitory antibodies to FVIII or FIX.\n\nNumber of participants:\n\nApproximately 85 participants will be enrolled into the study:\n\n* Approximately 60 fitusiran-naïve participants with severe hemophilia A or B, with or without inhibitors (fitusiran-naïve arm), and\n* Approximately 25 participants with severe hemophilia A or B with inhibitors rolling over from the EFC15467\\* dose confirmation study (roll-over arm).\n\n  * Fitusiran has been investigated in the pediatric population in study EFC15467, which enrolled male participants aged 1 to \\\u003C12 years with hemophilia A or B with inhibitors to examine the safety and tolerability of fitusiran in the pediatric population.\n\nParticipants will be enrolled into 1 of 2 arms:\n\n* Fitusiran-naïve: these participants have not previously received fitusiran, and they will undergo screening and study eligibility assessments. Once enrolled, they will go through a 24-week standard of care (SOC) period before starting fitusiran prophylaxis.\n* Roll-over participants from the EFC15467 study: only participants who are still on active treatment in study EFC15467 and consenting to study EFC17905 will be eligible to roll over. They will not need to undergo screening or further eligibility assessments. They will directly enroll into the fitusiran treatment period and continue treatment on their current fitusiran dose.\n\nThe duration of fitusiran treatment will be up to 160 weeks for the fitusiran-naïve arm and up to 60 weeks for the roll-over arm.",[424],"Hemophilia",{"date":262,"type":32},{"date":427,"type":32},"2025-12-18",{"date":429,"type":21},"2031-12-30",{"name":108,"class":39},30,{"id":433,"slug":4,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":450},"100615299","NCT07290803","This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment","Atopic Dermatitis Disease Registry of Adult and Adolescent Patients Initiating or Switching Systemic Treatments","ARMADA-AD","Inclusion Criteria:\n\n* Patients aged more than or equal to (≥) 12 years at the time of consent.\n* Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20.\n* Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)\n* Signed informed consent for registry participation by the patient or parent\u002Flegal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.\n\nExclusion Criteria:\n\n* Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.\n* Insufficient understanding of the study by the patient and\u002For parent\u002Fguardian.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":440,"type":21},1000,"The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.\n\nThe study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.",[443],"Atopic Dermatitis",{"date":262,"type":32},{"date":446,"type":32},"2025-11-17",{"date":448,"type":21},"2034-01-30",{"name":108,"class":39},59,{"id":452,"slug":4,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":343,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":461,"conditions":462,"keywords":464,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":474},"100512446","NCT05952557","An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+\u002FHER2- Early Breast Cancer (CAMBRIA-2)","CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+\u002FHER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease","CAMBRIA-2","Inclusion Criteria:\n\n* Women and Men; ≥18 years at the time of screening (or per national guidelines)\n* Histologically confirmed ER+\u002FHER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.\n* Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.\n* Patients must be randomised within 12 months of definitive breast surgery.\n* Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* Inoperable locally advanced or metastatic breast cancer\n* Pathological complete response following treatment with neoadjuvant therapy\n* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation\n* Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance \"\n* Known LVEF \\\u003C50% with heart failure NYHA Grade ≥2.\n* Mean resting QTcF interval \\> 480 ms at screening\n* Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions\n* Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)\n* Previous treatment with camizestrant, investigational SERDs\u002Finvestigational ER targeting agents, or fulvestrant\n* Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.\n* Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-\u002Fperi-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.",{"count":459,"type":21},5500,[24],"This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+\u002FHER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.",[463],"Breast Cancer, Early Breast Cancer",[465,466,467],"ER+","HER2-","breast cancer",{"date":262,"type":32},{"date":470,"type":32},"2023-10-05",{"date":472,"type":21},"2037-05-06",{"name":198,"class":39},798,{"id":476,"slug":4,"hasResults":11,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":22,"phases":483,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":496},"100597898","NCT07064473","EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease","EASi-PROTKT™ - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease","Inclusion Criteria :\n\n* At least 18 years old at time of consent\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).\n* Participants with medical history of hypertension and on active pharmacological treatment\n* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment\n* Established cardiovascular (CV) disease and on active pharmacological treatment\n* At least one additional risk factor for developing heart failure (HF)\n\nExclusion Criteria:\n\n* History of HF or hospitalization for HF or treatment of HF\n* Atrial fibrillation or Atrial flutter with a resting heart rate \\>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)\n* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)\n* Treatment with an Mineralocorticoid receptor antagonist (MRA)\n* Treatment with amiloride or other potassium-sparing diuretic\n* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:\n\n  * A direct renin inhibitor (e.g. aliskiren)\n  * More than one Angiotensin-converting enzyme inhibitor (ACEi) and\u002For Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously\n  * Other aldosterone synthase inhibitors (e.g. baxdrostat)\n  * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.",{"count":482,"type":21},11800,[24],"This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.\n\nParticipants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.\n\nParticipants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.",[486,286,487],"Diabetes Mellitus, Type 2","Cardiovascular Diseases","2026-06-23",{"date":401,"type":32},{"date":491,"type":32},"2025-07-22",{"date":493,"type":21},"2029-12-21",{"name":495,"class":39},"Boehringer Ingelheim",1155,{"id":498,"slug":4,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":515},"100584833","NCT06894498","Five PLus Year EffIcacy of Endoscopic Sleeve Gastroplasty (ESG) for Sustained WeigHT Loss","LIGHT","Inclusion Criteria:\n\n* Subject is ≥ 18 years of age at the time of the ESG procedure\n* Subject with a BMI between 30 kg\u002Fm2 and 50 kg\u002Fm2, inclusive, at the time of the primary ESG procedure using Overstitch Endoscopic Suturing System\n* Subject completed follow-up 1-year from the ESG procedure for weight loss management\n* Subject completed or is eligible for follow-up 5-years from the ESG procedure for weight loss management (visit can be collected either retrospectively or prospectively)\n* Subject has returned for a minimum of one annual follow-up at the treating site for weight loss management annually between two and four years from the procedure.\n* Subject is willing to complete one prospective visit (5 year or 5+ year, as appropriate)\n* Subject is able to read, understand, and sign a written Informed Consent Form to participate in the study\n\nExclusion Criteria:\n\n* None",{"count":118,"type":21},"The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.",[506,507],"Obesity and Obesity-related Medical Conditions","Weight Loss",{"date":262,"type":32},{"date":510,"type":32},"2026-03-31",{"date":512,"type":21},"2026-12",{"name":514,"class":39},"Boston Scientific Corporation",8,{"id":517,"slug":4,"hasResults":11,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":533},"100587975","NCT06935370","A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart","EASi-HF Reduced - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Chronic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) \u003C 40%","Inclusion criteria:\n\n1. At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial\n3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the protocol.\n4. Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with left ventricular ejection fraction (LVEF) \\\u003C 40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computed tomography (CT)).\n5. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory\n6. Treated according to best possible standard of care (SOC) (disregarding sodium-dependent glucose co-transporter 2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA)) in accordance with applicable heart failure (HF) local\u002Finternational guidelines and judgement of the investigator.\n\nAdditional inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with an MRA should not be discontinued with the intention of study enrolment.\n2. Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator.\n3. Receiving the following treatments:\n\n   * A direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * More than one angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNi) used simultaneously at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation\n     * i.v. diuretic with a dose that has been increased\u002Fintensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery (CABG), heart valve surgery\u002Fintervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, CABG)\n5. Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply.",{"count":523,"type":21},4200,[24],"This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure.\n\nIn this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat\u002Fempagliflozin tablets, and the other group takes placebo\u002Fempagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[77],{"date":401,"type":32},{"date":529,"type":32},"2025-05-20",{"date":531,"type":21},"2029-02-22",{"name":495,"class":39},635,{"id":535,"slug":4,"hasResults":11,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":552},"100564690","NCT06632457","LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Cirrhosis","A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction Associated Steatohepatitis (NASH\u002FMASH) Cirrhosis","Inclusion criteria:\n\n1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \\>18 years\n2. Body mass index (BMI) ≥27 kg\u002Fm2(≥25 kg\u002Fm2 for Asian trial participants)\n3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.\n4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB\u002Fm, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \\\u003C5% or FibroScan® with CAP \\\u003C288 dB\u002Fm is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis\u002Fsteatohepatitis.\n5. Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Current or history (\\\u003C5 years) of significant alcohol consumption, defined as an average of \\>140 g\u002Fweek in female patients and \\>210 g\u002Fweek in male patients, for a period of \\>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.\n2. Model of end-stage liver Disease (MELD) score \\>12 due to liver disease\n3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:\n\n   * Portal hypertension-related upper gastrointestinal (GI) bleeding\n   * Ascites\n   * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria\n4. Any of the following lab test result at screening\n\n   * Albumin below \\\u003C3.5 g\u002FdL (\\\u003C35.0 g\u002FL)\n   * International normalised ratio (INR) \\>1.3 unless due to therapeutic anticoagulants\n   * Total bilirubin (TBL) \\>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \\>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \\\u003C20% of TBL.\n   * Alkaline phosphatase \\>1.5x ULN\n   * PLT \\\u003C100,000\u002FµL (\\\u003C100 GI\u002FL)\n5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis\n6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection\n7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))\n8. Serum aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\>5x ULN\n9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history\n10. History of liver transplantation or listed for liver transplantation\n11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological\u002Fsurgical procedure for portal hypertension treatment\n12. Further exclusion criteria apply",{"count":541,"type":21},1590,[24],"This study is open to adults who are at least 18 years old and have:\n\n* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or\n* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)\n* BMI of 27 kg\u002Fm2 or more or\n* 25 kg\u002Fm2 or more if the participant is Asian.\n\nPeople with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.\n\nParticipants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.",[545],"Metabolic Dysfunction Associated Steatohepatitis",{"date":401,"type":32},{"date":548,"type":32},"2024-11-07",{"date":550,"type":21},"2029-06-05",{"name":495,"class":39},444,{"id":554,"slug":4,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":572},"100564689","NCT06632444","LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH\u002FMASH Who Have Moderate or Advanced Liver Fibrosis","A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis\u002FMetabolic Dysfunction-associated Steatohepatitis (NASH\u002FMASH) and (F2) - (F3) Stage of Liver Fibrosis","Inclusion criteria:\n\n1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent\n2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \\[NAS\\] ≥4\n3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used\n4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply\n\nExclusion criteria:\n\n1. Any of the following liver laboratory test abnormalities at screening:\n\n   * Serum AST and\u002For alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)\n   * Platelet count \\\u003C140 000\u002Fmm\\^3 (\\\u003C140 GI\u002FL)\n   * Alkaline phosphatase \\>2x upper limit of normal (ULN)\n   * Abnormal synthetic liver function as defined by screening central laboratory evaluation:\n\n     * Albumin below \\\u003C3.5 g\u002FdL (35.0 g\u002FL)\n     * OR International normalised ratio (INR) of prothrombin time \\>1.3\n     * OR total serum bilirubin concentration ≥1.5x ULN\n2. Any history or evidence of acute or chronic liver disease other than MASH\n3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy\n4. History of or current diagnosis of hepatocellular carcinoma\n5. History of or planned liver transplant\n6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.\n7. History of portal hypertension or presence of decompensated liver disease\n8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply",{"count":560,"type":21},1800,[24],"This study is open to adults who are at least 18 years old living with obesity and have:\n\n* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)\u002Fmetabolic associated steatohepatitis (MASH) and\n* moderate or advanced liver fibrosis\n\nPeople with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.\n\nThis study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.",[564,565],"Metabolic Dysfunction Associated Steatohepatitis (MASH)","Liver Fibrosis",{"date":401,"type":32},{"date":568,"type":32},"2024-09-17",{"date":570,"type":21},"2031-12-27",{"name":495,"class":39},525,""]