[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Ukraine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":566},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,155,0,25,[9,41,63,83,114,136,161,182,207,233,264,289,300,325,343,371,390,409,428,438,462,483,510,530,557],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"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},"100053698",false,"NCT07133633","A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a clinical diagnosis of axial spondyloarthritis (axSpA) and meets the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA including ≥3 months of back pain with age at symptom onset \\\u003C45 years\n* Meets the radiographic criterion of the modified New York criteria for ankylosing spondylitis (AS) as determined by central reading at Screening\n* Has active disease at Screening and Randomization\n* Has a history of inadequate response (IR)\u002Fintolerance to nonsteroidal anti-inflammatory drugs (NSAIDs) and is biologic disease-modifying antirheumatic drug (bDMARD)-naive, or has a history of IR\u002Fintolerance to up to a maximum of 2 bDMARD classes\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than radiographic axial spondyloarthritis (r-axSpA) (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis (PsA), systemic sclerosis, myositis, etc.), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of r-axSpA\n* Has a history of cancer (except fully treated non-melanoma skin cancers or cervical carcinoma in situ after complete surgical removal) within the last 5 years\n* Has any active infection\n* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients","ALL","18 Years","80 Years",{"count":20,"type":21},315,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and joints in the pelvis (hip bone). Radiographic means the damage it causes can be seen on X-rays.\n\nThis study will help find out if a study medicine called tulisokibart can treat symptoms of r-axSpA. Researchers will look at different doses of tulisokibart.\n\nResearchers want to know if at least one of the study doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.",[27],"Radiographic Axial Spondyloarthritis","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2025-09-26",{"date":36,"type":21},"2030-02-05",{"name":38,"class":39},"Merck Sharp & Dohme LLC","INDUSTRY",104,{"id":42,"slug":4,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100054283","NCT06717347","A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n* Has received no prior treatment for their DLBCL\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization\n* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\n* Has a history of transformation of indolent disease to DLBCL\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n* Has Ann Arbor Stage I DLBCL\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n* Has clinically significant pericardial or pleural effusion\n* Has ongoing Grade \\>1 peripheral neuropathy\n* Has a demyelinating form of Charcot-Marie-Tooth disease\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has ongoing corticosteroid therapy\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) lymphoma\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant",{"count":48,"type":21},1046,[50],"PHASE3","The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.",[53],"Diffuse Large B-Cell Lymphoma",[55],"Lymphoma, Large B-Cell, Diffuse",{"date":31,"type":32},{"date":58,"type":32},"2025-01-27",{"date":60,"type":21},"2032-03-29",{"name":38,"class":39},266,{"id":64,"slug":4,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":69,"maxAge":18,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"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",{"count":71,"type":21},1200,[50],"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).",[75],"Crohn's Disease",{"date":31,"type":32},{"date":78,"type":32},"2024-06-05",{"date":80,"type":21},"2029-11-12",{"name":38,"class":39},499,{"id":84,"slug":4,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100608438","NCT07201558","Study Evaluating Safety, Tolerability, PK\u002FPD of Surovatamig in Adult RA or SLE Participants","An Open-label, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Surovatamig Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus","ASSURO","Inclusion Criteria:\n\n1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive, at the time of signing the informed consent.\n2. For RA participants, only:\n\n\u003C!-- -->\n\n1. Diagnosis of RA as defined by the 2010 EULAR\u002FACR classification criteria\n2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory.\n\n   (a) RF (b) ACPA\n3. Moderate or severe disease activity defined as:\n\nDAS28-CRP \\> 3.2 AND\n\n* 4 tender joints and ≥ 4 swollen joints\n\n  (a) US-Specific Criterion: DAS28-CRP \\> 3.2 AND ≥ 6 tender joints and ≥ 6 swollen joints 4. Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b\u002FtsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance.\n\n  5\\. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12:\n\n  (a) Oral prednisone (or equivalent). Dose must be stable and ≤ 10mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (e.g. hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following csDMARDs for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg per week, without change of route of administration for 8 weeks prior to Day 1 (ii) Sulfasalazine ≤ 3g\u002Fday (iii) Leflunomide ≤ 20 mg\u002Fday 3. For SLE participants, only:\n  1. Diagnosis of SLE as defined by the 2019 EULAR\u002FACR classification criteria\n  2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory. If autoantibodies are negative on central laboratory test, documented history of test results may be used. (a) ANA immunofluorescent assay test (titer ≥ 1:80) (a) Anti-dsDNA (b) Anti-Sm.\n  3. Moderate or severe disease activity defined as clinical SLEDAI-2K \\> 4\n\n     (a) US-specific criterion: clinical SLEDAI-2K ≥ 6\n  4. Intolerance to or inadequate response following approximately 3 months treatment or longer ≥ 3 SoC (includes: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies). There is no minimum duration for taking a treatment in cases of intolerance.\n  5. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12: (a) Oral prednisone (or equivalent. Dose must be stable and ≤ 20mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (eg, hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following immunosuppressive treatments. for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg\u002Fweek, without change of route of administration for 8 weeks prior to Day 1 (ii) Mycophenolate mofetil or equivalent ≤ 2 g\u002Fday (dose must be ≤ 2 g\u002Fday for 3 months prior to Day 1) (iii) Azathioprine ≤ 200 mg\u002Fday (iv) Leflunomide ≤ 20 mg\u002Fday (v) Tacrolimus ≤ 0.1 mg\u002Fkg\u002Fday with maximum dose of 5 mg\u002Fday (vi) Cyclosporin ≤ 3 mg\u002Fkg\u002Fday with maximum dose of 200 mg\u002Fday\n\n  4\\. Blood B cells ≥ 50 cells\u002FμL at screening. 5. IgG levels ≥ 6 g\u002FL at screening. 6. Eligibility for re-treatment of previously treated participants only. The following criterion applies only to participants being considered for re-treatment and is not applicable to participants undergoing initial screening for study entry.\n\n  1\\. Participants treated in prior study cohorts who did not experience an IMP-related DLT or discontinue treatment and\u002For participation due to an IMP-related AE are eligible for re-treatment in Parts 2 and 3. Participants must otherwise meet all protocol-defined eligibility criteria, with the exception of Inclusion Criterion 17 (B cell count), and meet one of the 2 criteria below:\n  1. Completed the 6-month treatment period OR\n  2. Completed a minimum of 90 days in the treatment period and have peripheral B cell counts that are ≥ 90% of baseline or above lower limit of normal (LLN)\n\n     Exclusion Criteria:\n     1. Any complications of disease under study that are judged by the Investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to: (a) Active severe SLE-driven renal disease. (b) Severe lung or cardiac involvement. (c) History of, or current diagnosis of, catastrophic or severe APS (eg, diagnosis of an arterial or central\u002Fpulmonary venous clot) within 1 year prior to signing the ICF. Participants with clinically evident APS which is adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited into the study. (d) Rapidly progressive and\u002For severe ILD or ILD that requires oxygen supplementation\u002Ftherapy (of any type). (e) Felty's syndrome\n     2. History of HLH\u002FMAS.\n     3. For RA participants, only:\n\n     \u003C!-- -->\n\n     1. Juvenile idiopathic arthritis or idiopathic arthritis diagnosed before the age of 16.\n     2. Axial spondylarthritis or any other disease associated with inflammatory arthritis\n\n     4\\. For SLE participants, only:\n\n     1.History of active, severe or unstable neuropsychiatric SLE, except for headache and peripheral neuropathies. 5. Other active or prior documented severe, complex, autoimmune or inflammatory disorders. Exceptions to this exclusion criteria include: (a) Vitiligo or alopecia (b) Hypothyroidism stable on hormone replacement (c) Controlled type I diabetes mellitus on insulin (d) Any chronic skin condition that does not require systemic immunosuppressant or biologic therapy (e) Celiac disease, controlled by diet alone (f) Participants with secondary Sjögren's disease are eligible provided that immunosuppression is primarily prescribed for the disease under study (ie, SLE or RA) and not for secondary Sjögren's. 6. Significant CNS co-morbidity (eg, Parkinson's, stroke, CNS vasculitis, severe brain injury, dementia, neurodegenerative diseases, cerebellar disease, epilepsy\u002Fseizure disorders, PML, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases).\n\n     7\\. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.\n\n     8\\. Exclusion Criteria Related to Infection:\n\n     1\\. Any clinical suspicion or diagnosis of active infection at screening. 2. Opportunistic infection that meets criteria to be an SAE within 3 years. 3. Clinically significant chronic infection (for example osteomyelitis, bronchiectasis) with treatment completed less than 2 months prior to signing the ICF (except for chronic nail infections which are not exclusionary) 4. Any infection requiring hospitalisation or treatment with IV anti-infectives with treatment completed less than 4 weeks prior to signing the ICF.\n\n     5\\. Any infection requiring oral anti-infectives within 2 weeks prior to signing the ICF.\n\n     6\\. History of recurrent infection requiring hospitalisation or IV antibiotics (eg, 3 or more of the same type of infection, including systemic fungal infections, over the previous 52 weeks).\n\n     9\\. Participants who, as judged by the Investigator, have evidence of active TB, or latent TB or have a household contact with known diagnosis of current active TB.\n\n  \u003C!-- -->\n\n  1. TB evaluation will be performed according to the local SoC as determined by local guidelines and may include history and physical examinations, chest X-ray, or TB test (eg, purified protein derivative or QuantiFERON® test).\n  2. Participants with a prior diagnosis of active or latent TB who have documented evidence they have completed a full course of appropriate treatment are not excluded.\n\n     However, a previous history of multidrug-resistant or extensively drug-resistant TB is exclusionary regardless of treatment status. 10. Participant with human immunodeficiency virus infection (confirmed by central laboratory at screening) 11. Participant with active EBV or CMV, assessed clinically. 12. Participant with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive (tested at screening visit).\n\n     13\\. Participant with evidence of chronic or active Hepatitis C, meeting any of the criteria below: (a) HCV RNA positive or detectible at screening (b) HCV antibody positive at screening (apart from those with negative HCV RNA \\>12 weeks after completion of curative antiviral treatment for HCV or those with sustained negative HCV RNA 12 weeks apart following resolution of HCV infection if not treated).\n\n     14\\. Participant positive with COVID-19 PCR at screening. If patients test positive at screening or Day 1 but meet other eligibility criteria, they may be re-tested after ≥ 2 weeks. If this falls within the screening window, then they do not require re-screening.\n\n     15\\. Receipt of any of the following treatments or interventions ever: (a) TCEs, with the exception of surovatamig under the conditions specified in Inclusion Criterion 19 (b) Bone marrow transplant (c) Stem cell transplant (d) Total lymphoid irradiation (e) CAR-T cell therapy (f) Alemtuzumab 16. For females only - currently pregnant (confirmed with positive pregnancy test), planning to become pregnant within the study period, or breast feeding.","65 Years",{"count":92,"type":21},48,[94],"PHASE1","This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.",[97,98],"Rheumatoid Arthritis","Systemic Lupus Erythematosus",[100,101,102,103],"adult participants","rheumatoid arthritis","systemic lupus erythematosus","surovatamig","2026-07-01",{"date":106,"type":32},"2026-07-02",{"date":108,"type":32},"2025-12-02",{"date":110,"type":21},"2028-06-27",{"name":112,"class":39},"AstraZeneca",33,{"id":115,"slug":4,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":122,"type":21},15100,[50],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[126],"Cardiovascular Disease",[128],"Atherosclerotic Cardiovascular Disease",{"date":106,"type":32},{"date":131,"type":32},"2025-06-04",{"date":133,"type":21},"2029-10-26",{"name":112,"class":39},1365,{"id":137,"slug":4,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":145,"phases":4,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":160},"100268233","NCT02771236","Clinical and Molecular Studies in Families With Inherited Eye Disease","* INCLUSION CRITERIA:\n\nTo be eligible, the following inclusion criteria must be met, where applicable;\n\n1. Participant must be four years of age or older.\n2. Participant must understand and sign the protocol s informed consent document.\n3. Individuals or family members of individuals with inherited eye diseases, either congenital, childhood, or age related.\n4. All participants must be able to cooperate with study examination and phlebotomy.\n\nEXCLUSION CRITERIA:\n\nA participant is not eligible if any of the following exclusion criteria are present:\n\n1. Participant has a disease, infection, or trauma that mimics inherited cataracts, retinal degenerations, glaucoma, etc.\n2. Participant has a significant active infection (an infection requiring treatment as determined by the investigator) or a history of chronic or recurrent infections.\n3. Participant requires sedation for study purposes.","4 Years","120 Years",{"count":144,"type":21},5000,"OBSERVATIONAL","Background:\n\nGenes are the basic units of heredity. When genes are changed, certain cells don t work like they should. Researchers want to try to better understand the genetic conditions that are linked with inherited eye diseases.\n\nObjective:\n\nTo try to identify the genes linked to the development of inherited eye diseases.\n\nEligibility:\n\nPeople ages 4 and older who have or have a family member with an inherited eye disease\n\nDesign:\n\nParticipants will be screened with medical history and medical records.\n\nParticipants will have one visit that will take 3-4 hours. This will include:\n\nMedical and family history\n\nEye exam: This includes the pupil being dilated.\n\nElectroretinography: A small electrode is taped to the forehead. Participants sit in the\n\ndark with their eyes patched for 30 minutes. Then numbing drops and contact lenses are put in\n\nthe eyes. They will watch flashing lights.\n\nBlood tests\n\nSaliva sample: They will spit into a container or have the inside of their cheek swabbed.\n\nGenetic testing will be done on participants blood or saliva.\n\nParticipants may meet with the researchers to discuss their genetic tests.\n\n...",[148],"Inherited Eye Disease",[150,151],"Genetics","Natural History",{"date":106,"type":32},{"date":154,"type":32},"2016-10-04",{"date":156,"type":21},"2032-01-01",{"name":158,"class":159},"National Eye Institute (NEI)","NIH",10,{"id":162,"slug":4,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":69,"maxAge":18,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100607159","NCT07184931","An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","STARSCAPE-1","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \\\u003C18 years of age who meet the definition of Tanner Stage 5 for development\n* Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline\n* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)\n\nExclusion Criteria:\n\n* Participants with Ulcerative Colitis (UC) or indeterminate colitis\n* Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum\n* Prior or current high-grade gastrointestinal (GI) dysplasia\n* Participants on treatment with but not on stable doses of conventional therapy prior to baseline\n* Participants receiving prohibited medications or therapies\n* Participants with previous exposure to anti-TL1A investigational therapy\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":169,"type":21},980,[50],"This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:\n\nThe study duration may be up to 35 weeks with:\n\n* Up to 5-week Screening Period.\n* 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction).\n* 12-week Sub-Study 3 (Extended Induction for non-responders).\n* 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.\n\nThe number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.",[75],"2026-06-30",{"date":104,"type":32},{"date":176,"type":32},"2025-10-01",{"date":178,"type":21},"2029-05-14",{"name":180,"class":39},"Sanofi",301,{"id":183,"slug":4,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":196,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},"100590383","NCT06966700","A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)","A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin\u002FPaclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive\u002FHuman Epidermal Growth Factor Receptor-2 Negative Breast Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and\u002For clinical assessment:\n\n  * cT1c, N1-N2\n  * cT2, N0-N2\n  * cT3, N0-N2\n  * cT4a-d, N0-N2\n* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+\u002FHER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement\n* Has received any prior treatment, including radiation, systemic therapy,and\u002For definitive surgery for currently diagnosed breast cancer\n* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and\u002For axillary sentinel lymph node biopsy prior to study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).\n* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Uncontrolled systemic disease.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids, has current pneumonitis\u002Finterstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..",{"count":189,"type":21},2400,[50],"Researchers are looking for new ways to treat types of breast cancer that are both:\n\n* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment\n* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive\u002Fhuman epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.\n\nSacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.\n\nThe main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:\n\n* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy\n* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy",[193,194,195],"Breast Neoplasms","Triple Negative Breast Neoplasms","HR Low-Positive\u002FHER2-Negative Breast Neoplasms",[197,198,199],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)",{"date":106,"type":32},{"date":202,"type":32},"2025-06-30",{"date":204,"type":21},"2034-12-29",{"name":38,"class":39},310,{"id":208,"slug":4,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":222,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100588118","NCT06937229","A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)","A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)","Inclusion Criteria:\n\n* Participants must have completed study CN012-0023 or CN012-0024 per protocol.\n* Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).\n\nExclusion Criteria:\n\n* Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","55 Years","90 Years",{"count":216,"type":21},650,[50],"The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate\u002Ftrospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.",[220,221],"Alzheimer Disease","Agitation",[221,223,224,225],"Alzheimer disease","KarXT","KarX-EC",{"date":104,"type":32},{"date":108,"type":32},{"date":229,"type":21},"2029-07-20",{"name":231,"class":39},"Bristol-Myers Squibb",256,{"id":234,"slug":4,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":22,"phases":242,"briefSummary":244,"conditions":245,"keywords":249,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":258,"leadSponsor":260,"locationsCount":263},"100639897","NCT07599072","PREdiabetes GLycemic Impact and Data Evaluation","Evaluation of the Impact of Continuous Glucose Monitoring (CGM) Systems on Glycemic Control in People With Prediabetes: Postmarketing Clinical Study","PRE-GLIDE","Inclusion Criteria:\n\n* Age of 18 years and older.\n* Presence of prediabetes diagnosed according to criteria of the American Diabetes Association\n* Persons who treated with diet and exercise alone or metformin on a stabilized dose for at least 3 months before the study;\n* Ability to comply with protocol requirements and maintain a patient diary.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Presence of type 1 or type 2 diabetes;\n* Decompensated liver or kidney diseases (GFR \\\u003C 45 ml\u002Fmin\u002F1. 73 m²);\n* Active cardiovascular diseases within 12 months of Visit 1, such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study;\n* Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia;\n* Pregnancy or lactation;\n* Mental or cognitive impairments that would interfere with study participation;\n* Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months;\n* Recent use of any CGM within the last 12 months;\n* Known allergy to sensor materials;\n* Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant;\n* Participation in another clinical study within the last 3 months.",{"count":241,"type":21},80,[243],"NA","This prospective, randomized controlled trial evaluates whether real-time continuous glucose monitoring (CGM) improves glycemic control and lifestyle adherence in adults with prediabetes compared to conventional self-monitoring methods over a 3-month period. By analyzing metabolic markers and behavioral data, the study aims to determine the effectiveness of 24-hour monitoring as a personalized tool that increases patient adherence to lifestyle changes compared to conventional SMBG methods.",[246,247,248],"Pre Diabetic","Obesity & Overweight","Insulin Resistance",[250,251,252,253,254],"prediabetes","obesity","continuous glucose monitoring","insulin resistance","traditional glycemia self-monitoring","2026-06-29",{"date":173,"type":32},{"date":104,"type":21},{"date":259,"type":21},"2027-06-30",{"name":261,"class":262},"Nazarii Kobyliak","OTHER",3,{"id":265,"slug":4,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":272,"type":21},645,[24],"This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[276,277,278,279],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative","2026-06-26",{"date":255,"type":32},{"date":283,"type":32},"2025-05-27",{"date":285,"type":21},"2028-03",{"name":287,"class":39},"Spyre Therapeutics, Inc.",243,{"id":290,"slug":4,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":51,"conditions":293,"keywords":294,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":297,"leadSponsor":298,"locationsCount":299},"100571215",{"count":48,"type":21},[50],[53],[55],{"date":255,"type":32},{"date":58,"type":32},{"date":60,"type":21},{"name":38,"class":39},263,{"id":301,"slug":4,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":312,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":324},"100637440","NCT07615010","A Clinical Trial to Evaluate agenT-797 Plus Standard of Care in Participants With Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure","Phase 2 Adaptive Randomized, Placebo -Controlled Trial of agenT-797 + Standard of Care Vs. Placebo + Standard of Care in Severe Pneumonia With Moderate to Severe Acute Hypoxemic Respiratory Failure (AHRF) By Global ARDS Criteria","Key Inclusion Criteria:\n\n* Admission to an intensive care unit (ICU) with severe pneumonia of any etiology (viral, bacterial, fungal, or mixed), with and without trauma based on clinical suspicion\n* Acute hypoxemic respiratory failure (AHRF)\n* Evidence of moderate to severe acute respiratory distress syndrome (ARDS) based on Global ARDS criteria\n* Onset of severe pneumonia with AHRF ≤7 days prior to informed consent\n\nKey Exclusion Criteria:\n\n* More than two vasopressors to maintain a mean arterial pressure ≥65 millimeters of mercury at the time of informed consent\n* Pregnancy or breastfeeding\n* History of cytokine release syndrome, as documented in the medical record or reported by the participant, legally authorized representative, or close relative\n* Current participation in another interventional clinical trial, or receipt of an investigational medicinal product within 30 days prior to screening, unless reviewed and approved in writing by the medical monitor\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":307,"type":21},90,[24],"This clinical trial will evaluate the efficacy and safety of a single intravenous dose of agenT-797 administered in addition to standard of care (SOC), compared with placebo plus SOC, in reducing short-term mortality in adult participants with severe pneumonia and moderate to severe AHRF. All participants will receive SOC management for severe pneumonia and acute respiratory distress syndrome (ARDS).",[311],"Pneumonia",[313,314,315],"Acute Hypoxemic Respiratory Failure","AHRF","agenT-797","2026-06-25",{"date":280,"type":32},{"date":319,"type":32},"2026-05-26",{"date":321,"type":21},"2027-08",{"name":323,"class":39},"MiNK Therapeutics",4,{"id":326,"slug":4,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},"100635565","NCT07554339","A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015\u002FKANDLELIT-015)","A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology.\n* Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.\n* Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research.\n* Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.\n* If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART).\n* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy.\n* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.\n* Has a body weight ≥35 kg.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.\n* Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Is HIV-infected with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has received prior treatment (other than definitive CCRT) for NSCLC.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years.\n* Has a history of, or has current, (noninfectious) pneumonitis\u002Finterstitial lung disease that required\u002Frequires steroids.\n* Has an active infection requiring systemic therapy.\n* Has a history of stem cell\u002Fsolid organ transplant.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.",{"count":206,"type":21},[50],"Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy.\n\nThe goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.",[335],"Non-small Cell Lung Cancer",{"date":280,"type":32},{"date":338,"type":32},"2026-06-18",{"date":340,"type":21},"2037-08-17",{"name":38,"class":39},16,{"id":344,"slug":4,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":353,"conditions":354,"keywords":358,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":370},"100629875","NCT07480356","Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer","A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-Grade Non-Muscle Invasive Bladder Cancer","ADVANCED-3","Inclusion Criteria:\n\n* Male or female participants 18 years of age or older at the time of signing informed consent\n* Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry\n* Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta\u002FT1) with active disease\n* Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis, or participants who received ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis\n\nExclusion Criteria:\n\n* Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory\n* Central confirmed variant histology\n* Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment\n* Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)\n* Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history\n\nFor more information on eligibility criteria, please contact the Sponsor.",{"count":351,"type":21},284,[50],"The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older.\n\nThe main questions it aims to answer are:\n\n* Can the study drug help participants with this type of cancer?\n* Is the study drug safe?\n* What are the side effects of the study drug?\n\nResearchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.",[355,356,357],"Bladder (Urothelial, Transitional Cell) Cancer","Non-Muscle Invasive Bladder Carcinoma","Non-muscle Invasive Bladder Cancer With Carcinoma in Situ",[359,360,361,362],"BCG-naive","Non-muscle invasive bladder Cancer","bladder cancer","carcinoma in situ",{"date":255,"type":32},{"date":365,"type":32},"2026-05-29",{"date":367,"type":21},"2032-11",{"name":369,"class":39},"Protara Therapeutics",6,{"id":372,"slug":4,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":389},"100630383","NCT07486960","Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a clinical diagnosis of PsA and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening, with symptom onset ≥6 months before Screening.\n* Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis.\n* Has history of biologic disease-modifying antirheumatic drug (bDMARD)-naïve or bDMARD-inadequate response\u002Fintolerant.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than PsA (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, myositis, etc), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of PsA.\n* Has a skin condition diagnosis, other than psoriasis that may, in the judgment of the investigator, interfere with the assessment of psoriasis.\n* Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years before Randomization.\n* Has any active infection.\n* Has known allergies, hypersensitivity, or intolerance to tulisokibart of its excipients.",{"count":378,"type":21},140,[24],"Researchers are looking for new ways to treat Psoriatic Arthritis (PsA). This study will help find out if a study medicine called tulisokibart (MK-7240) can treat symptoms of active PsA. This study assesses the efficacy, safety, and tolerability of tulisokibart in adult participants with active PsA.\n\nIn this study, researchers will look at different doses of tulisokibart. Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen PsA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.",[382],"Psoriatic Arthritis",{"date":255,"type":32},{"date":385,"type":32},"2026-04-20",{"date":387,"type":21},"2030-01-11",{"name":38,"class":39},45,{"id":391,"slug":4,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":22,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":408},"100626145","NCT07431827","MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)","A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)","KANDLELIT-013","Inclusion Criteria:\n\n* Has a histological\u002Fcytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria:\n\n  * Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC\n  * Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy.\n* Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation\n* No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention.\n* Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest\u002Fabdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention\n* Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy\n* Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\n* Has a diagnosis of any 1 of the following tumor types\u002Flocations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention\n* Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption)\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has active infection requiring systemic therapy\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":398,"type":21},400,[50],"This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.",[335],{"date":280,"type":32},{"date":404,"type":32},"2026-03-18",{"date":406,"type":21},"2039-10-26",{"name":38,"class":39},58,{"id":410,"slug":4,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":421,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":113},"100612373","NCT07252739","KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J\u002FKEYMAKER-U01J)","KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically or cytologically confirmed diagnosis of advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC)\n* Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutations\n* Can provide an archival tumor tissue sample or newly obtained core, incisional, excisional biopsy of a tumor lesion not previously irradiated\n* Has recovered to ≤Grade 1 or baseline from any Adverse events (AEs) due to previous anticancer therapies and\u002For ≤Grade 2 neuropathy and\u002For endocrine-related AEs adequately treated with hormone replacement\n* Has well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) if HIV-infected\n* Has undetectable hepatitis B (HBV) viral load and have received HBV antiviral therapy for at least 4 weeks if hepatitis B surface antigen (HBsAg) positive\n* Has undetectable hepatitis C (HCV) viral load if HCV-infected\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* Has HIV-infection with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease\n* Has uncontrolled, clinically significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to \\>470 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention\n* Has received prior systemic anticancer therapy for advanced or metastatic NSCLC\n* Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis\n* Has received previous treatment with an agent targeting KRAS\n* Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from AE associated with anticancer therapy before allocation\u002Frandomization\n* Has received radiation therapy to the lung that is \\>30 Gray within 6 months of start of study intervention\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has a known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has a history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":416,"type":21},130,[24],"Researchers want to learn if using a study medicine called MK-1084 can help treat NSCLC. MK-1084 is a type of treatment called targeted therapy for the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C gene change. The goal of this study is to learn about the safety of MK-1084 and to learn how many people have the cancer get smaller or go away during the study treatment.",[420],"Malignant Neoplasm",[197,198,199],{"date":280,"type":32},{"date":424,"type":32},"2025-12-19",{"date":426,"type":21},"2033-01-14",{"name":38,"class":39},{"id":429,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":25,"conditions":432,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":435,"leadSponsor":436,"locationsCount":437},"100603216",{"count":20,"type":21},[24],[27],{"date":255,"type":32},{"date":34,"type":32},{"date":36,"type":21},{"name":38,"class":39},102,{"id":439,"slug":4,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":445,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":461},"100589229","NCT06951698","A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)","BALSAM-1","Inclusion Criteria\n\n* Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.\n* Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).\n* Participants must require hospitalization for the acute exacerbation or relapse of mania.\n* Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.\n* Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.\n* Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.\n\nExclusion Criteria:\n\n* Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n* Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).\n* Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.\n* Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).\n* Participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n* Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":446,"type":21},274,[50],"The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder",[450],"Bipolar-I Disorder With Mania or Mania With Mixed Features",[452,453,454],"Bipolar-I","Mania","Mixed",{"date":280,"type":32},{"date":457,"type":32},"2025-06-11",{"date":459,"type":21},"2026-11-01",{"name":231,"class":39},69,{"id":463,"slug":4,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":470,"briefSummary":471,"conditions":472,"keywords":474,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":482},"100576716","NCT06788912","Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E\u002FKEYMAKER-U01)","KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC)\n* Able to undergo protocol therapy, including necessary surgery\n* Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.\n* Is able to provide archival or newly obtained core\u002Fexcisional biopsy of the primary lung tumor or lymph node metastasis.\n\nExclusion Criteria:\n\n* Has one of the following tumor locations\u002Ftypes: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.\n* Has Grade ≥2 peripheral neuropathy.\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Active infection requiring systemic therapy.\n* Hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) \\[qualitative\\]) infection.\n* Known history of human immunodeficiency virus (HIV) infection.\n* History of allogeneic tissue\u002Fsolid organ transplant.",{"count":469,"type":21},60,[24],"The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.",[473],"Lung Neoplasm Malignant",[197,475,199],"Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)",{"date":280,"type":32},{"date":478,"type":32},"2025-03-20",{"date":480,"type":21},"2032-02-06",{"name":38,"class":39},38,{"id":484,"slug":4,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":509},"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":144,"type":21},[50],"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",[494],"Chronic Kidney Disease and Hypertension",[496,497,498,499,500,501,502],"Chronic kidney disease","Hypertension","Blood pressure","Baxdrostat","Dapagliflozin","Event-Driven","Outcome",{"date":280,"type":32},{"date":505,"type":32},"2025-03-03",{"date":507,"type":21},"2029-12-18",{"name":112,"class":39},764,{"id":511,"slug":4,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":22,"phases":519,"briefSummary":520,"conditions":521,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":529},"100567400","NCT06667700","A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)","A Phase 3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adults With COVID-19 at High Risk for Disease Progression","MOVe-NOW","Inclusion Criteria\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is an individual of any sex\u002Fgender, ≥18 years of age\n* Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization\n* Has initial onset of signs\u002Fsymptoms attributable to COVID-19 for ≤4 days prior to the day of randomization and ≥2 of the following signs\u002Fsymptoms attributable to COVID-19 on the day of randomization: cough, sore throat, nasal congestion, shortness of breath or difficulty breathing with exertion, muscle or body aches, fatigue, fever \\>38.0°C or chills, nausea or vomiting or diarrhea, change in sense of smell or change in sense of taste, or headache\n* Has ≥1 of the following characteristics or medical conditions associated with the highest risk of severe illness from COVID-19:\n\n  * Advanced age of ≥75 years of age\n  * Immunocompromised\n  * Neurocognitive or physical disability\n  * Has ≥3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g., chronic lung disease, obesity with body mass index (BMI) ≥35, diabetes)\n* Is unable or unwilling to receive treatment with nirmatrelvir\u002Fritonavir (NMV\u002Fr) due to 1 or more of the following:\n\n  * Is receiving drug(s) highly dependent on cytochrome P450 3A (CYP3A) for clearance and for which elevated concentrations are associated with serious and\u002For life-threatening consequences or drug(s) with a clinically significant drug-drug interaction for which co-administration is not possible\n  * Is receiving potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance\n  * Has severe hepatic impairment\n  * Has experienced prior adverse reactions or hepatotoxicity to NMV\u002Fr that would preclude future use\n  * Has known or suspected NMV\u002Fr resistance\n  * Has uncontrolled HIV infection\n  * NMV\u002Fr is not approved\u002Fauthorized in the participant's country or it is not accessible to participant (e.g., drug shortage)\n  * Is unwilling to receive treatment with NMV\u002Fr\n\nInclusion note: Participants may receive remdesivir as standard of care in addition to molnupiravir or placebo. If remdesivir is available and clinically appropriate per local clinical practice, investigators will aim to ensure that those who are most vulnerable to severe COVID-19 receive timely access to remdesivir as standard of care on this study.\n\nExclusion Criteria\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently\n* Has received or plans to receive SARS-CoV-2 directed oral antivirals or monoclonal antibodies for current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as standard of care)\n* Has ≥1 of the following signs\u002Fsymptoms that are attributable to severe or critical COVID-19:\n\n  * Shortness of breath at rest\n  * Respiratory rate ≥30 breaths per minute\n  * Heart rate ≥125 beats per minute\n  * Peripheral oxygen saturation (SpO2) ≤93% on room air or on supplemental oxygen for a reason other than COVID-19 which has not increased since onset of COVID-19 signs\u002Fsymptoms\n  * New or increasing need for supplemental oxygen: receiving \\>4 liters\u002Fminute supplemental oxygen due to COVID-19 OR on supplemental oxygen for a reason other than COVID-19 which has increased due to COVID-19\n* Has received a COVID-19 vaccine within 30 days prior to randomization\n* Has a history of confirmed influenza, respiratory syncytial virus (RSV), or SARS-CoV-2 infection (with or without symptoms; excluding current infection) within 30 days prior to randomization\n* Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir",{"count":518,"type":21},3082,[50],"Researchers are looking for other ways to prevent severe illness from COVID-19. COVID-19 is a virus that most often causes mild flu or cold-like symptoms. However, people with certain health conditions or other factors have a high risk (chance) of getting severely ill from COVID-19, which can require a hospital stay or lead to death. Some people who are high risk for severe illness may be unable to take certain treatments for COVID-19 because they are not available to them, or they take other medicines that may react with a treatment and cause an unwanted effect.\n\nMolnupiravir (MK-4482) is a study medicine designed to stop the COVID-19 virus from copying itself in the body (multiplying). The goal of this study is to learn if molnupiravir prevents severe illness from COVID-19 more than placebo in people who are high risk.",[522],"Coronavirus Disease (COVID-19)",{"date":280,"type":32},{"date":525,"type":32},"2024-12-02",{"date":527,"type":21},"2031-01-26",{"name":38,"class":39},224,{"id":531,"slug":4,"hasResults":11,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":11,"sex":16,"minAge":536,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":22,"phases":539,"briefSummary":540,"conditions":541,"keywords":543,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":556},"100543874","NCT06361537","Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks","Prospective, Multicenter, Randomized, Double-blind, Parallel Group, Placebo- Controlled, Efficacy and Safety Phase 3 Study of an Intravenous Human Plasma- Derived C1 Esterase Inhibitor (C1-INH) Concentrate in Participants With Congenital C1-INH Deficiency for the Treatment and Pre-procedure Prevention of Acute Hereditary Angioedema Attacks","Inclusion Criteria:\n\n1. Is at least 18 years of age (applicable for 1st study phase) or is at least 2 years of age (applicable for 2nd study phase)\n2. Has confirmed diagnosis of HAE type I or II\n3. Has had at least 3 moderate or severe HAE attacks (excluding extremity attacks) in the last 3 months before the Screening Visit. For participants ≥2 and ≤12 years of age, has had at least 1 moderate or severe HAE attack (excluding extremity attacks) in the last 6 months before Screening Visit\n4. Has a documented congenital C1-INH functional activity \\\u003C50% with or without C1-INH deficiency and C4 antigen level below the laboratory reference range\n5. Participant or the participant's legally authorized representative(s) has signed informed consent (as required by local law), with the assent of participants legally capable of providing it, as applicable\n6. States willingness to comply with all study procedures and availability for the duration of the study\n7. If the participant is of childbearing potential (CBP), has a negative pregnancy test and must have been using a highly effective method of contraception and continue to do so until at least 2 weeks after their last dose (for both blinded and open-label doses of IMP). Not of CBP is defined as surgically sterilized (hysterectomy, bilateral oophorectomy) or who are postmenopausal (defined as women with no menses for 12 months without an alternative medical cause). Highly effective methods of contraception:\n\n   * Combined hormonal contraception (estrogens and progesterone) methods such as oral, implantable, intravaginal, injectable, or transdermal contraceptives at a stable dose for a minimum of 1 full cycle (hormonal contraceptives must inhibit ovulation) and for at least 4 weeks before screening\n   * Progesterone only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n   * Intrauterine device\n   * Intrauterine hormone-releasing system inserted at least 4 weeks before screening\n   * Bilateral tubal ligation\u002Focclusion or vasectomized partner (with surgical success confirmed by medical assessment) OR Agrees to abstain from heterosexual intercourse during study participation and to use a highly effective contraceptive (as described above) as backup if they become sexually active during the study. Abstinence is only acceptable if this is the participant's usual lifestyle. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception\n   * Note: If a participant of CBP has a positive or suspected positive urine pregnancy test within 72 hours prior to treatment, a serum pregnancy test will be required\n   * Male participants must not plan to father a child or donate sperm for 90 days after their last dose of study drug (for both blinded and open-label doses of the IMP). However, there are no official contraception requirements for male participants during the study.\n\nInclusion Criteria for IMP Dosing for QAT:\n\n1. Has confirmed QAT per definition criteria\n2. Has a swelling episode that is new and not the continuation of a previous HAE attack\n\nExclusion Criteria:\n\n1. Has a history of clinically relevant antibody development against C1-INH\n2. Has a medical history consistent with Type 3 HAE (i.e., onset at age above 40 year, no family history, no known HAE mutation, low C1q level in plasma)\n3. Has a history of allergic reaction to C1-INH or other blood\u002Fplasma product\n4. Has a history of B-cell malignancy that was unresolved in the past 5 years\n5. Has a narcotic and\u002For alcoholic addiction\n6. Has participated in any other investigational drug evaluation within 30 days before screening\n7. Is pregnant or breastfeeding\n8. Has any clinically significant medical or psychiatric condition that, in the investigator's opinion would interfere with the participant's ability to participate in the study\n9. Has a history of thromboembolic events (TEEs), myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, transient ischemic attack, severe peripheral vascular disease, or disseminated intravascular coagulation within one year before screening\n10. (applicable until IDMC review of the interim preliminary safety and efficacy data): has clinically significant derangement in measurements of cardiovascular status (i.e. uncontrolled arterial hypertension, cardiac insufficiency New York Heart Association (NYHA) class III-IV), pulmonary status (i.e., COPD GOLD classification 3 and 4, severe asthma) and renal status (i.e., eGFR below 90 ml\u002Fmin per 1.73 m2)\n\nExclusion Criteria for IMP Dosing for QAT:\n\n1. Has received blood or a blood product for prophylactic or acute treatment with any C1-INH (Berinert®, Cinryze®, HAEgarda®, Ruconest®, etc.), non-biological bradykinin and kallikrein pathway inhibitors (e.g., ecallantide, icatibant, berotralstat), or treatment with tranexamic acid within 14 days before dosing with the IMP (or is not willing to abstain from these medications throughout the study)\n2. started or changed hormone replacement therapy or selective estrogen receptor modulators (e.g., tamoxifen) within 14 days before IMP dosing\n3. Started or changed androgen therapy (e.g. testosterone, dehydro- epiandrosterone\u002Fandrostenedione, oxandrolone, danazol, stanozolol) within 14 days before IMP dosing or is not willing to maintain a stable dose throughout the study\n4. Started or changed the dose of monoclonal antibodies e.g. lanadelumab within 11 weeks before dosing or not willing to maintain a stable dose throughout the study\n5. Has used narcotic pain medications or non-opioid analgesics within 7 days before IMP dosing for a QAT\n6. Has received OCTA-C1-INH within 14 days before IMP dosing\n\nExclusion Criteria for IMP Dosing for PK:\n\n1. Has received blood or a blood product for prophylactic or acute treatment with any C1-INH (Berinert®, Cinryze®, HAEgarda®, Ruconest®, etc.), non-biological bradykinin and kallikrein pathway inhibitors (e.g., ecallantide, icatibant, berotralstat), or treatment with tranexamic acid within 14 days before dosing with the IMP (or is not willing to abstain from these medications throughout the study)\n2. Is receiving hormone replacement therapy or selective estrogen receptor modulators (e.g., tamoxifen) and has had their dose changed within 14 days before IMP dosing\n3. Is receiving or has received androgen therapy (e.g., testosterone, dehydroepiandrosterone\u002Fandrostenedione, oxandrolone, danazol, stanozolol) IN ANY DOSE within 14 days before dosing\n4. Started or changed the dose of monoclonal antibodies e.g lanadelumab within 11 weeks before dosing or not willing to maintain a stable dose throughout the study\n5. Has used narcotic pain medications or non-opioid analgesics within 7 days before IMP dosing\n6. Has received IMP within 14 days before IMP dosing\n7. Has planned dental, medical, or surgical procedures during the PK Period that will require pre-procedural prevention","2 Years",{"count":538,"type":21},124,[50],"Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks",[542],"Acute Hereditary Angio Edema",[544,545,546,547,548],"Edema","Swelling","Angio Edema","Hereditary","Congenital Angioedema",{"date":173,"type":32},{"date":551,"type":32},"2024-04-30",{"date":553,"type":21},"2027-06",{"name":555,"class":39},"Octapharma",21,{"id":558,"slug":4,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":69,"maxAge":18,"enrollmentInfo":559,"targetDuration":4,"studyType":22,"phases":560,"briefSummary":73,"conditions":561,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":564,"leadSponsor":565,"locationsCount":82},"100549191",{"count":71,"type":21},[50],[75],{"date":255,"type":32},{"date":78,"type":32},{"date":80,"type":21},{"name":38,"class":39},""]