[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"South Africa\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":672},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,303,0,25,[9,55,85,108,140,161,182,214,235,258,292,319,351,381,415,439,461,484,494,516,542,569,603,628,649],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100053387","phase-3-a-study-evaluating-the-efficacy-and-safety-of-pegozafermin-in-participants-with-mash-and-fibrosis-enlighten-fibrosis-100053387",false,"NCT06318169","A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)","A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)\n* Biopsy-confirmed MASH with fibrosis stage F2 or F3\n* Body mass index (BMI) at screening ≥25.0 kilograms (kg)\u002Fmeters squared (m\\^2) (≥23 kg\u002Fm\\^2 for Asian participants).\n\nKey Exclusion Criteria:\n\n* Chronic liver diseases other than MASH\n* Evidence of cirrhosis on screening liver biopsy\n* Have type 1 diabetes or poorly controlled type 2 diabetes\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U\u002FL)\n* Participants taking vitamin E (\\>400 international units \\[IU\\]\u002Fday) or pioglitazone must be on stable dose for at least 6 months prior to Screening\n\nOther inclusion and exclusion criteria may apply.","ALL","18 Years","80 Years",{"count":21,"type":22},1350,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.",[28],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Fibrosis",[30,31,32,33,34,35,36,37,38,39,40,41],"Liver Diseases","Fatty Liver","Digestive System Diseases","Metabolic diseases","Metabolic Dysfunction-Associated Steatohepatitis","MASH","Steatohepatitis","Metabolic dysfunction-associated steatotic liver disease","MASLD","Nonalcoholic fatty liver disease","NAFLD","Fibrosis","RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":46},"2024-03-13",{"date":50,"type":22},"2029-02",{"name":52,"class":53},"89bio, Inc.","INDUSTRY",361,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":17,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100053313","phase-3-study-to-evaluate-the-efficacy-and-safety-of-abelacimab-in-high-risk-patients-with-atrial-fibrillation-who-have-been-deemed-unsuitable-for-oral-anticoagulation-lilac-timi-76-100053313","NCT05712200","Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","LILAC-TIMI 76","Inclusion Criteria:\n\n* Patient is able to understand and has provided written informed consent to participate in the trial\n* Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)\n* Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3\n* Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study\n* At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls\n* Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study\n\nExclusion Criteria:\n\n* AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)\n* Patients who within 60 days prior to randomization (1) received a vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (DOAC) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF\n* Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment\n* Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization\n* Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study\n* Patients on dialysis at screening or who are planned to start dialysis within 6 months\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply","65 Years",{"count":65,"type":22},2500,[25],"A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.",[69],"Atrial Fibrillation (AF)",[71,72,73,74,75,76],"abelacimab","randomized","placebo-controlled","double-blind","endpoint evaluation","atrial fibrillation",{"date":45,"type":46},{"date":79,"type":46},"2022-12-27",{"date":81,"type":22},"2027-12-30",{"name":83,"class":53},"Anthos Therapeutics, Inc.",789,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":92,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100054324","phase-3-a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-with-metastatic-prostate-cancer-mk-2400-001-100054324","NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE",{"count":94,"type":22},1440,[25],"Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[98,99],"Prostate Cancer","Prostatic Neoplasms",{"date":45,"type":46},{"date":102,"type":46},"2025-05-13",{"date":104,"type":22},"2031-01-06",{"name":106,"class":53},"Merck Sharp & Dohme LLC",290,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100053442","phase-3-a-study-to-evaluate-mezigdomide-bortezomib-and-dexamethasone-mezivd-versus-pomalidomide-bortezomib-and-dexamethasone-pvd-in-participants-with-relapsed-or-refractory-multiple-myeloma-rrmm-100053442","NCT05519085","A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)","A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1","SUCCESSOR-1","Inclusion Criteria\n\n\\- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.\n\ni) M-protein ≥ 0.5 grams per deciliter (g\u002FdL) by serum protein electrophoresis (sPEP) or.\n\nii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).\n\niii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \\> 100 mg\u002FL (10 mg\u002FdL) involved light chain and an abnormal kappa\u002Flambda FLC ratio.\n\n* Participants received 1 to 3 prior lines of antimyeloma therapy.\n* Participants achieved minimal response \\[MR\\] or better to at least 1 prior antimyeloma therapy.\n\nExclusion Criteria\n\n\\- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.\n\ni) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.\n\nii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.\n\n* For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.\n* Participant has had prior treatment with mezigdomide or pomalidomide.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":117,"type":22},810,[25],"The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.",[121],"Relapsed or Refractory Multiple Myeloma",[123,124,125,126,127,128,129,130,131],"Multiple myeloma","RRMM","MeziVd","PVd","CC92480","pomalidomide","bortezomib","dexamethasone","mezigdomide",{"date":45,"type":46},{"date":134,"type":46},"2022-09-20",{"date":136,"type":22},"2033-11-30",{"name":138,"class":53},"Celgene",266,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100054263","phase-2-a-clinical-study-of-islatravir-and-ulonivirine-for-people-with-hiv-1-who-have-not-been-treated-before-mk-8591b-062-100054263","NCT07266831","A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)","A Phase 2\u002F3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir\u002FEmtricitabine\u002FTenofovir Alafenamide (BIC\u002FFTC\u002FTAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1","Inclusion Criteria:\n\n* Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies\u002FmL.\n* Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 copies\u002FmL.\n* Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells\u002Fmm\\^3.\n* Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.\n\nExclusion Criteria:\n\n* Has human immunodeficiency virus type 2 (HIV-2) infection.\n* Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.\n* Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.\n* Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.\n* Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.",{"count":148,"type":22},570,[150,25],"PHASE2","Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.",[153],"Human Immunodeficiency Virus Type 1 (HIV-1) Infection",{"date":45,"type":46},{"date":156,"type":46},"2025-12-18",{"date":158,"type":22},"2030-04-03",{"name":106,"class":53},55,{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":139},"100054283","phase-3-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-2140-010-100054283","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":169,"type":22},1046,[25],"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.",[173],"Diffuse Large B-Cell Lymphoma",[175],"Lymphoma, Large B-Cell, Diffuse",{"date":45,"type":46},{"date":178,"type":46},"2025-01-27",{"date":180,"type":22},"2032-03-29",{"name":106,"class":53},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":192,"briefSummary":193,"conditions":194,"keywords":198,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":213},"100054235","phase-3-zilebesiran-in-patients-with-hypertension-not-adequately-controlled-and-with-either-established-cardiovascular-disease-or-high-risk-for-cardiovascular-disease-100054235","NCT07181109","Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH","Inclusion Criteria:\n\n* Is 18 years or older for patients with established cardiovascular disease (CVD)\n* Is 55 years or older for patients with high risk for CVD\n* Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD\n* Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic\n\nExclusion Criteria:\n\n* Has known history of secondary hypertension\n* Has symptomatic orthostatic hypotension\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3×upper limit of normal (ULN)\n* Has total serum bilirubin \\>1.5×ULN\n* Has international normalized ratio (INR) \\>1.5\n* Has serum potassium \\>4.8 mEq\u002FL\n* Has estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m\\^2",{"count":191,"type":22},11000,[25],"The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.",[195,196,197],"High Risk Cardiovascular Disease","Hypertension","High Cardiovascular Risk",[199,200,201,202,203,204,205],"High blood pressure","siRNA","Angiotensinogen","AGT","Cardiovascular disease","Uncontrolled hypertension","RNAi",{"date":45,"type":46},{"date":208,"type":46},"2025-09-22",{"date":210,"type":22},"2030-09-30",{"name":212,"class":53},"Alnylam Pharmaceuticals",995,{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":17,"minAge":221,"maxAge":19,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100053921","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100053921","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":223,"type":22},1200,[25],"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).",[227],"Crohn's Disease",{"date":45,"type":46},{"date":230,"type":46},"2024-06-05",{"date":232,"type":22},"2029-11-12",{"name":106,"class":53},499,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":17,"minAge":242,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},"100053407","phase-2-efficacy-safety-and-pharmacokinetics-of-vericiguat-in-pediatric-participants-with-heart-failure-due-to-left-ventricular-systolic-dysfunction-mk-1242-036-100053407","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days","17 Years",{"count":245,"type":22},342,[150,25],"This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[249,250],"Heart Failure","Left Ventricular Systolic Dysfunction",{"date":45,"type":46},{"date":253,"type":46},"2023-05-31",{"date":255,"type":22},"2032-04-15",{"name":106,"class":53},107,{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":291},"100053289","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-remibrutinib-in-secondary-progressive-multiple-sclerosis-100053289","NCT07225504","A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis","A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Remibrutinib in Patients With Secondary Progressive Multiple Sclerosis","REMASTER","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to any assessment performed.\n* Male or female participants aged 18-65 (inclusive) at Screening.\n* Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) at Screening\n* Absence of documented clinical relapses in the 24 months before Screening and randomization.\n* EDSS score of 3.0 to 6.0 (inclusive) at Screening.\n* Documented evidence of disability progression in the 12 months before Screening.\n\nExclusion Criteria:\n\n* Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).\n* History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).\n* Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.\n* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.\n* Women of childbearing potential (WOCBP), unless they are using highly effective methods of contraception (failure rate \\\u003C 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.\n* Significant bleeding risk or coagulation disorders, at Screening.\n* Use of exclusionary medication prior to Screening\u002Frandomization as listed in the protocol.\n\nOther protocol-defined inclusion\u002Fexclusion critria may apply",{"count":267,"type":22},1275,[25],"The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)",[271],"Secondary Progressive Multiple Sclerosis (SPMS)",[273,274,275,276,277,278,279,280,281,282],"MS","Multiple sclerosis","secondary progressive multiple sclerosis","SPMS","remibrutinib","LOU064","adult","Expanded Disability Status Scale","EDSS","McDonald diagnostic criteria","2026-07-09",{"date":45,"type":46},{"date":286,"type":46},"2025-11-11",{"date":288,"type":22},"2034-01-02",{"name":290,"class":53},"Novartis Pharmaceuticals",236,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":299,"maxAge":300,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"100054316","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-qmf149-indacaterol-acetatemometasone-furoate-versus-budesonide-in-children-from-6-to-less-than-12-years-of-age-with-asthma-100054316","NCT05562466","A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate\u002FMometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate \u002F Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Inclusion Criteria\n\n1. Male or female children ≥ 6 years and \\\u003C12 years in age at randomization.\n2. Parents\u002Flegal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period)).\n3. Confirmed\u002Fdocumented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment.\n4. Written and signed informed consent by parent(s)\u002Flegal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.\n5. Patient receiving daily treatment of stable low dose ICS alone (i.e. up to 100ug daily dose of fluticasone propionate DPI or equivalent) without additional controller OR low dose ICS (up to 100ug daily dose of fluticasone propionate DPI or equivalent) with one additional controller prior to starting run-in and eligible after run-in on mono ICS alone (fluticasone 100ug\u002Fday) for at least 3 weeks (run-in period) prior to randomization.\n6. All patients must be symptomatic at randomization (Visit 30), as defined by ACQ-IA≥1.5. Patients previously on low dose ICS may be included for run-in only if ACQ-IA score ≥1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n\n   Patients previously on low dose ICS with one controller may do the wash out of the controller before the start of run-in and be included for run-in only if ACQ-IA score ≥ 1 and \\\u003C1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n7. Pre-Bronchodilator FEV1 ≥50% of predicted normal at start of Run-in (Visit 20) and end of Run-in (Visit 30).\n\n   Withholding period of bronchodilators prior to spirometry at all time:\n\n   SABA for ≥ 6 hours. For loose combinations of ICS\u002FLABA\\* a wash-out of ≥ 48 hours before Visit 20 is required (14 days for once daily combinations, i.e. indacaterol), short acting anticholinergic (SAMA) for ≥ 8 hours and xanthines ≥7 days.\n\n   \\* In case of combination ICS\u002FLABA at screening, ICS alone should be continued. Wash-out period of each drug should be adhered to as above and should not be longer. If wash-out period is considered to be longer, please contact the Novartis Medical Monitor.\n\n   A one-time repeat of percent predicted FEV1 (pre-bronchodilator FEV1) within 5 days of the Visit is allowed at Visit 20 as well as Visit 30. That would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment. At Visit 20, the Run-in medication should be dispensed only once the repeat spirometry was qualified, and if all inclusion criteria at Visit 20 are successfully met.\n\n   If patient fails to meet the pre FEV1 criteria for technical reasons, a rescreen is allowed once and in this circumstance, patients are not required to go back on prior medication (low dose ICS with or without controller) for the full 4 weeks duration and the rescreen can be scheduled at site's convenience. In this case all assessments must be done according to protocol's requirements.\n8. FEV1 bronchodilator responsiveness testing using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in Visit (Visit 20): increase \\> and\u002For = 12% (performed according to ATS\u002FERS 2019 guidelines). All patients must perform a bronchodilator responsiveness test at start of Run-in. If responsiveness is not demonstrated at Run-in, it may be repeated once on the same day. If responsiveness is still not demonstrated after repeat, documentation of historical reversibility is accepted. If not available patients must be screen failed. Spacers may be used for bronchodilator responsiveness testing.\n9. Demonstrate acceptable inhaler use technique with Breezhaler® at randomization, as well as acceptable use of other study devices and be able to complete spirometry procedures.\n10. A parent\u002Flegal guardian is to complete all e-Diary entries and attend all clinic visits with the patient. It is recommended, if possible, to have the same parent\u002Flegal guardian to complete the e-diary entries and attend clinic visits with the patient.\n11. Have a documented negative COVID-19 test (validated PCR or antigenic test)) within 3 days prior to randomization visit.\n12. For optional Pharmacokinetics (PK) analysis: Participants willing to participate in the optional PK analysis will need to weigh at least 25 kg at screening.\n\nExclusion Criteria Participants meeting any of the following criteria are not eligible for inclusion in this study.\n\n1. Prior intubation for asthma.\n2. Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (\\>24h) or emergency room visit (≤24 hours).\n3. Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period.\n4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.\n5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.\n6. History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and\u002For urea values, or abnormal urinary constituents (e.g. albuminuria) according to investigator's judgement.\n\n   * Evidence of urinary obstruction, or difficulty in voiding\n   * Evidence of congenital renal abnormalities with an established effect on renal function\n   * Calculated eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2 using the Bedside Schwartz formula.\n7. Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Visit 1, or between Visit 1 and Visit 30.\n\n   Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.\n8. Any chronic condition of the respiratory tract which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.\n9. Patient with evidence upon visual inspection (laboratory culture not required) of clinically significant (upon the opinion of the investigator) oropharyngeal candidiasis at Visit 30 or earlier, with or without treatment, Patients may be rescreened once their candidiasis has been treated and has resolved.\n10. History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease), chronic obstructive pulmonary disease (COPD) and asthma\u002FCOPD overlap syndrome (ACOS).\n11. Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in or Baseline (Fridericia method) is prolonged (≥ 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened).\n12. Subjects who have a clinically significant ECG abnormality reported before Visit 30 (End of Run-in).\n13. Subjects who have a clinically significant abnormal laboratory values as per investigator judgement or abnormal liver chemistry results (i.e. ALT, AST, total bilirubin, alkaline phosphatase, GGT and albumin above the upper limit of normal) reported before Visit 30 (End of Run-in).\n14. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.\n15. Subjects who, in the opinion of the investigator, are not able to be compliant with study treatment or who have any medical or mental disorder, situation, or diagnosis which could interfere with the proper completion of the protocol requirements or risk the subject's safety while participating in the study.\n16. Subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.\n17. Patients who have been treated with long-acting theophylline preparations within four weeks prior to Screening and\u002For during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Screening.\n18. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and\u002For during the screening period.\n19. Use of Long-Acting Muscarinic Antagonist (LAMA) as maintenance treatment within 3 months prior to Screening.\n20. Evidence of unstable disease within 4 weeks prior to Screening (Visit 1) that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition\u002Fdisease exacerbated during the study.\n21. History of hypersensitivity to any ingredients of the study drugs including fluticasone propionate, indacaterol acetate, mometasone furoate, budesonide and salmeterol\u002Falbuterol or drug of similar chemical classes. This includes any known hypersensitivity or intolerance to the excipients, including lactose.\n22. Patients with Type I diabetes or uncontrolled Type II diabetes either by HBA1c\\>8 or as per judgement of investigator prior to End of Run-In (Visit 30)\n23. Patients receiving any asthma-related or non asthma-related prohibited medications as specified in the protocol.\n24. Immunotherapy or desensitization for allergies started within 3 months prior to Visit 20, or where the maintenance dose is expected to change during the study.\n25. Female patients of childbearing potential defined as all females physiologically capable of becoming pregnant (including female pediatric patients who are menarchal or who become menarchal during the study)) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria.\n\nEffective contraception methods include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps). For UK: with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F vaginal suppository\n* Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) If using oral contraception females should have been stable on the same pill for a minimum of 3 months before taking investigational drug. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.","6 Years","11 Years",{"count":302,"type":22},200,[25],"The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) \u002F mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.\n\n* The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.\n* The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.",[306],"Asthma",[306,308,309,310,311],"Pediatric","Breezhaler","QMF149","Budesonide",{"date":45,"type":46},{"date":314,"type":46},"2023-05-11",{"date":316,"type":22},"2028-05-30",{"name":290,"class":53},63,{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":341,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":350},"100053737","phase-2-study-of-advanced-therapies-for-the-treatment-of-adult-participants-with-moderately-to-severely-active-crohns-disease-or-ulcerative-colitis-100053737","NCT07697456","Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","Inclusion Criteria:\n\nCD specific:\n\n* Crohn's Disease Activity Index (CDAI) score of ≥ 220\n* Confirmed diagnosis of CD at least 90 days prior to Baseline\n* Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.\n* Demonstrated failure of 1 or more therapy for CD\n\nUC specific:\n\n* Confirmed diagnosis of UC at least 90 days prior to Baseline\n* Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3\n* Demonstrated failure of 1 or more therapy for UC\n\nExclusion Criteria:\n\n* Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)\n* Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment\n* Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame\n* Participants with surgical bowel resection within the past 3 months prior to Baseline\n\nCD specific:\n\n* Participants with \\>3 prior bowel resections\n* Participants with previous small bowel resection(s) of combined length \\>100 cm\n\nUC specific:\n\n* Participants with prior colectomy (total or subtotal)\n* Participants with extent of disease limited to \\\u003C 10 cm of rectum","75 Years",{"count":328,"type":22},2000,[150],"Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC).\n\nThis study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.",[227,332],"Ulcerative Colitis",[334,335,336,337,338,339,340],"Crohn's disease","Ulcerative colitis","Risankizumab","ABBV-701","Trosunilimab","ABBV-466","ABBV-7066","NOT_YET_RECRUITING","2026-07-07",{"date":45,"type":46},{"date":345,"type":22},"2026-07-24",{"date":347,"type":22},"2031-10",{"name":349,"class":53},"AbbVie",30,{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":358,"sex":17,"minAge":18,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":367,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":380},"100053316","phase-2-pilot-study-of-prenatal-choline-supplementation-100053316","NCT07699393","Pilot Study of Prenatal Choline Supplementation","A Randomized, Double-Blind, Placebo-controlled Clinical Trial of Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Development: Pilot Arm for Non-Drinking Women","Inclusion Criteria:\n\n* Age ≥18 yr\n* ≤20 wk gestation\n* Singleton pregnancy\n* Abstinence from alcohol since conception (by report)\n* Current choline dietary intake \\\u003C1 g\u002Fday\n* Language fluency in English or Afrikaans\n\nExclusion Criteria:\n\n* Use of methamphetamine or other illicit drugs other than marijuana during the past year\n* HIV positive\n* Pharmacologic treatment for a serious pre-existing medical condition (e.g., diabetes, hypertension, epilepsy, or cardiac problems)\n* Having another child enrolled in the trial from a previous pregnancy\n* Plans for mother or child to move away from the area prior to study completion",true,"45 Years",{"count":361,"type":22},50,[150],"We are conducting a double-blind, randomized, placebo-controlled trial (RCT; NCT04395196) of prenatal choline supplementation (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of PAE on three primary outcomes: infant recognition memory and postnatal growth restriction (weight and head circumference); (2) to assess the efficacy of this supplementation for mitigating alcohol effects on the following secondary outcomes: infant eyeblink conditioning, postnatal length, and information processing speed. The study design was based on a pilot feasibility study in 70 heavy-drinking pregnant women. Infants in the choline-treated arm were more likely to meet criterion for eyeblink conditioning than those in the placebo arm. Infants born to both the choline- and placebo-treated mothers were small at birth, but those in the choline arm showed considerable catch-up growth in weight and head circumference by 6.5 months, which persisted through 12 months. At 12 months, infants in the choline arm showed markedly better recognition memory compared to placebo-treated on the Fagan Test of Infant Intelligence, which is known to have predictive validity for school-age IQ. Of note, infants with heavy prenatal alcohol exposure whose mothers were in the active choline treatment arm performed better on FTII novelty preference neurobehavioral testing than infants in an observational study that was running in parallel who had no prenatal alcohol exposure. These pilot findings indicate that any beneficial effects of prenatal choline supplementation seen may be due in part or entirely due to general beneficial effects on fetal brain development rather than mechanisms that are specific to the teratogenic effects of alcohol. Thus, we currently seek to enroll and randomize 50 alcohol-abstaining pregnant women to participate in an identical study protocol (same study procedures and primary and secondary outcomes) to NCT04395196, which includes only alcohol-consuming pregnant women. Effect sizes between this pilot, non-drinking group and the larger study of alcohol-consuming women will be compared to explore the degree to which prenatal choline supplementation benefits growth and neurobehavior in infants without prenatal alcohol exposure and to explore the degree to which beneficial treatment effects of choline are specific to prenatal alcohol exposure.",[365,366],"Brain Development","Choline Nutrition",[368,369,370],"Choline","Prenatal nutrition","dietary supplementation","2026-07-06",{"date":45,"type":46},{"date":374,"type":22},"2026-07-08",{"date":376,"type":22},"2028-05-15",{"name":378,"class":379},"Wayne State University","OTHER",1,{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":358,"sex":389,"minAge":221,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":414},"100590067","mentor-moms-study-100590067","NCT06962592","Mentor Moms+ Study","A Community-based Adaptation of a Peer-led Intervention to Address Alcohol Use and HIV Risk in Pregnant Women in South Africa (Mentor Moms+)","(MM+)","Inclusion Criteria:\n\n* • ≥ 16 years;\n\n  * Pregnancy confirmed;\n  * reported alcohol use during pregnancy (in last 2 months);\n  * lives within 20 kilometers of the study facility;\n  * able and willing to consent to study participation.\n\nExclusion Criteria:\n\n* Individuals not meeting the above criteria will be excluded.","FEMALE",{"count":391,"type":22},100,[393],"NA","The goal of this study is to adapt an existing evidence based intervention for use in pregnant and lactating people (PLP) who use alcohol. Through the pilot RCT, we aim to understand if tailored intervention, Mentor Mothers+, is effective in reducing alcohol use (primary outcome) and improving antiretroviral (PrEP or ART) adherence (secondary outcomes) among pregnant and breastfeeding women living with and without HIV in a community heavily burdened by this syndemic.\n\nThe investigators will conduct an pilot randomized control trial in 100 pregnant women, recruited during antenatal care (ANC) visits within the Saldanha Bay Municipality clinic in Cape Town, South Africa. The RCT will involve the delivery of brief, individual motivational interviewing sessions provided by trained mentor mothers from the community who are on either PrEP (living without HIV) or ART (living with HIV) and who stopped or reduced alcohol use during pregnancy. The enrolled participants will be followed for a 6-month period spanning both pregnancy and postpartum stages.",[396,397],"HIV","Alcohol Consumption",[399,400,401,402,403,404],"pregnant","postpartum","HIV prevention","HIV treatment","Alcohol use","breastfeeding","2026-07-01",{"date":407,"type":46},"2026-07-02",{"date":409,"type":46},"2025-09-01",{"date":411,"type":22},"2027-08-31",{"name":413,"class":379},"University of California, Los Angeles",2,{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":438},"100592970","phase-3-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-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":424,"type":22},15100,[25],"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.",[428],"Cardiovascular Disease",[430],"Atherosclerotic Cardiovascular Disease",{"date":407,"type":46},{"date":433,"type":46},"2025-06-04",{"date":435,"type":22},"2029-10-26",{"name":437,"class":53},"AstraZeneca",1365,{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":460},"100576853","phase-3-a-study-evaluating-the-efficacy-and-safety-of-inavolisib-plus-cdk46-inhibitor-and-letrozole-vs-placebo--cdk46i-and-letrozole-in-participants-with-endocrine-sensitive-pik3ca-mutated-hormone-receptor-positive-her2-negative-advanced-breast-cancer-100576853","NCT06790693","A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4\u002F6 Inhibitor and Letrozole vs Placebo + CDK4\u002F6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4\u002F6 Inhibitor and Letrozole Versus Placebo Plus a CDK4\u002F6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","INAVO123","Inclusion Criteria:\n\n* Women or men with histologically or cytologically confirmed carcinoma of the breast\n* Documented ER-positive and\u002For progesterone receptor-positive tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines\n* Documented HER2-negative tumor according to ASCO\u002FCAP guidelines\n* De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant\u002Fadjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment\n* Participants who have bilateral breast cancers which are both HR-positive and HER2-negative\n* Confirmation of biomarker eligibility\n* Consent to provide fresh or archival tumor tissue specimen\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate hematologic and organ function within 14 days prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Metaplastic breast cancer\n* Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye\n* Symptomatic active lung disease\n* History of or active inflammatory bowel disease\n* Any active bowel inflammation\n* Prior hematopoietic stem cell or bone marrow transplantation\n* Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment",{"count":448,"type":22},450,[25],"This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4\u002F6i) and letrozole versus placebo plus a CDK4\u002F6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).",[452],"Breast Cancer",{"date":407,"type":46},{"date":455,"type":46},"2025-04-09",{"date":457,"type":22},"2032-05-30",{"name":459,"class":53},"Hoffmann-La Roche",232,{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":468,"maxAge":469,"enrollmentInfo":470,"targetDuration":4,"studyType":23,"phases":471,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":483},"100506775","phase-3-a-study-to-evaluate-the-long-term-safety-of-astegolimab-in-participants-with-chronic-obstructive-pulmonary-disease-copd-100506775","NCT05878769","A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)","A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* Completion of the 52-week treatment period in either parent GB43311 or GB44332\n\nExclusion Criteria:\n\n* Withdrawal of consent and\u002For premature discontinuation from parent study\n* Any permanent discontinuation of study drug in parent study\n* Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment\n* Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study\n* Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study\n* Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study","40 Years","90 Years",{"count":328,"type":22},[25],"The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.",[474],"Chronic Obstructive Pulmonary Disease",[476],"chronic obstructive pulmonary disease, COPD",{"date":407,"type":46},{"date":479,"type":46},"2023-06-28",{"date":481,"type":22},"2034-07-01",{"name":459,"class":53},486,{"id":485,"slug":4,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":119,"conditions":488,"keywords":489,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":492,"leadSponsor":493,"locationsCount":139},"100479138",{"count":117,"type":22},[25],[121],[123,124,125,126,127,128,129,130,131],{"date":407,"type":46},{"date":134,"type":46},{"date":136,"type":22},{"name":138,"class":53},{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":502,"maxAge":243,"enrollmentInfo":503,"targetDuration":4,"studyType":23,"phases":505,"briefSummary":506,"conditions":507,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":515},"100442302","phase-2-a-study-to-evaluate-the-efficacy-safety-and-pharmacokinetics-of-obinutuzumab-in-adolescents-with-active-class-iii-or-iv-lupus-nephritis-and-the-safety-and-pk-of-obinutuzumab-in-pediatric-participants-100442302","NCT05039619","A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants","A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to \u003C 12)","POSTERITY","Inclusion Criteria:\n\n* Participants who are age 12 to \\\u003C18 years at the time of randomization\n* Participants who are age 5 to \\\u003C12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)\n* International Society of Nephrology and the Renal Pathology Society (ISN\u002FRPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening\n* Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible\n* Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria\n* Significant proteinuria defined by a UPCR above \\> 0.5 based on a first-morning void (FMV) collection at screening\n* During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg\u002Fkg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.\n\nExclusion Criteria:\n\n* Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia\n* Sclerosis in \\>50% of glomeruli on renal biopsy\n* Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions\n* Presence of rapidly progressive glomerulonephritis\n* Pure Class V LN\n* Intolerance or contraindication to study therapies\n* Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization\n* History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders\n* History of serious recurrent or chronic infection\n* History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years\n* Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation\n* Currently active alcohol or drug abuse or history of alcohol or drug abuse","5 Years",{"count":504,"type":22},40,[150],"This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \\\u003C12 with LN.",[508],"Lupus Nephritis",{"date":407,"type":46},{"date":511,"type":46},"2022-05-12",{"date":513,"type":22},"2030-06-14",{"name":459,"class":53},42,{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":358,"sex":389,"minAge":221,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":23,"phases":525,"briefSummary":526,"conditions":527,"keywords":529,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":541},"100636762","a-study-to-evaluate-the-performance-usability-and-contrived-result-interpretation-of-istatis-gonorrhea-antigen-test-100636762","NCT07569900","A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test","A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test by Trained Personnel at Near-Patient or Point-of-Care Settings","Inclusion Criteria\n\n* Age \\> 16 years\n* Subject (or legally authorized representative) is willing to provide written informed consent before any study procedures\n* Female gender\n* Subject is able and willing to provide vaginal swab specimen for study procedures (3-4 swabs)\n* Subject can complete the required testing on the allocated testing day\n* Subject can speak, read, and write English\n* Subject's demographic information, risk factors, and symptoms are available and can be recorded on case report forms\n* Subject agrees to comply with study procedures and sample collection for both the investigational device and the reference method\n* Subject is willing to participate in the study site's standard-of-care Gonorrhea counselling and testing program and receive standard-of-care test results, as required and applicable\n* Subject is indicated for sexually transmitted infection testing for one or more of the following reasons:\n\n  * At risk of Gonorrhea, such as recent unprotected intercourse, multiple or new partners within \\\u003C 60 days, known exposure to an infected partner, or prior STI history\n  * Having signs and\u002For symptoms suggestive of Gonorrhea (e.g., urethral, vaginal, rectal, or pharyngeal discharge; dysuria; pelvic or lower-abdominal pain; sore throat; or rectal discomfort)\n  * Undergoing routine or opportunistic STI screening, including family-planning, antenatal, or sexual-health clinic visits\n  * Undergoing re-testing (test-of-cure) \\> 7 days after completion of Gonorrhea treatment and clinically stable\n  * Undergoing co-testing for other STIs where Gonorrhea testing is part of a broader diagnostic panel\n\nExclusion Criteria\n\n* Subject 15 years of age or younger\n* Male gender\n* Female currently menstruating\n* Subject is unable or unwilling to provide informed consent\n* Subject is medically unstable or has psychiatric condition(s) that pose a risk or prevent study compliance\n* Subject is unable to provide paired samples for reference testing\n* Subject requires urgent antimicrobial treatment before specimen collection\n* Subject received systemic or topical antibiotics active against Gonorrhea within the previous 7 days\n* Subject used topical intravaginal or rectal antiseptics within 48 hours prior to study sampling\n* Previously enrolled for the same infection episode\n* Anatomical or clinical contraindication to study sampling (e.g., severe cervical pathology)\n* Recent urogenital procedure (e.g., cystoscopy, lavage) \\\u003C 72 hours before study sampling\n* Subject belongs to a protected group excluded by local ethics (e.g., incarcerated persons), unless explicitly approved by the EC\u002FIRB\n* Any condition that, in the opinion of trained personnel or study staff, would make the participant unsuitable or unsafe for enrolment, interfere with completion of assessments, consent, or questionnaires, or bias study outcomes\n* Subject is participating in another interventional clinical study within 30 days that could interfere with study results",{"count":524,"type":22},650,[393],"The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by trained personnel.",[528],"Gonorrhea Infection",[530,531,532],"Gonorrhea test","Point-of-care test","iStatis test","2026-06-30",{"date":407,"type":46},{"date":536,"type":46},"2025-11-26",{"date":538,"type":22},"2027-01-01",{"name":540,"class":53},"bioLytical Laboratories",3,{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":551,"briefSummary":552,"conditions":553,"keywords":555,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":568},"100632727","phase-2-bactericidal-activity-and-safety-of-nicotinamide-in-combination-with-bedaquiline-pretomanid-and-linezolid-in-drug-susceptible-pulmonary-tuberculosis-100632727","NCT07517445","Bactericidal Activity and Safety of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Drug-susceptible Pulmonary Tuberculosis","A Phase 2, Open-label, Randomized Controlled Trial to Assess the Safety, Bactericidal Activity, and Pharmacokinetics of Nicotinamide in Combination With Bedaquiline, Pretomanid, and Linezolid in Adults With Drug-susceptible Pulmonary Tuberculosis","Inclusion Criteria:\n\n* Age 18-65 years at consent\n* Body weight 40-100 kg at screening\n* Written informed consent obtained\n* Newly diagnosed pulmonary TB, rifampicin- and isoniazid-sensitive\n\n  * ≥1+ AFB smear OR positive Xpert semi-quantitative result\n  * Molecular confirmation of M. tuberculosis\n* Chest X-ray consistent with TB (Investigator assessment)\n* Able to spontaneously produce sputum\n* Contraception requirements met\n* Females Of Child Bearing Potential: 2 approved contraceptive methods or abstinence\n* Males: contraception or abstinence through 90 days post-dose\n\nExclusion Criteria:\n\n* Prior TB within 3 years, \\>1 prior episode, or anti-TB treatment within 60 days\n* Extrapulmonary TB (except non-significant pleural\u002Flymph node disease)\n* Clinically significant comorbidities or substance abuse impacting safety\u002Fcompliance\n* Pregnant or breastfeeding\n* HIV-positive AND any of the following:\n* Not on ART or on ART \\\u003C3 months\n* CD4 \\\u003C200 cells\u002FµL\n* Viral load \\>200 copies\u002FmL\n* AIDS-defining illness (other than pulmonary TB)\n* Screening lab abnormalities (protocol-defined LFTs, hematology, hepatitis B or C, HbA1c)\n* Clinically significant ECG abnormality\n* Use of prohibited concomitant medications (e.g., strong CYP3A4 modifiers, certain SSRIs)",{"count":550,"type":22},165,[150],"The purpose of this study is to determine if nicotinamide in combination with bedaquiline, pretomanid, and linezolid, is safe and effective in treating drug-susceptible pulmonary tuberculosis.",[554],"Drug Susceptible Pulmonary Tuberculosis",[556,557,558,559,560],"Nicotinamide","bedaquiline","pretomanid","linezolid","drug-susceptible pulmonary tuberculosis",{"date":407,"type":46},{"date":563,"type":46},"2026-04-17",{"date":565,"type":22},"2027-06-14",{"name":567,"class":379},"Gates Medical Research Institute",4,{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":23,"phases":578,"briefSummary":579,"conditions":580,"keywords":585,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":602},"100613423","phase-3-a-study-to-investigate-efficacy-safety-and-tolerability-of-barzolvolimab-versus-placebo-in-adults-with-cold-induced-urticaria-and-symptomatic-dermographism-inadequately-controlled-by-h1-antihistamines-embarq---coldu-and-sd-100613423","NCT07266402","A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants With Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)","Key Inclusion Criteria:\n\n1. Males and females, \\>\u002F= 18 years of age.\n2. Diagnosis of cold induced urticaria or symptomatic dermographism \\>\u002F= 3 months.\n3. Diagnosis of cold induced urticaria or symptomatic dermographism despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:\n\n   1. The presence of hives for \\>\u002F= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.\n   2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \\>\u002F= 4 weeks prior to study treatment.\n   3. Cold induced urticaria: A Critical Threshold Temperature (CTT) of ≥ 15 °C and \\\u003C 37 °C using the TempTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test.\n   4. Symptomatic dermographism: A Critical Friction Threshold (CFT) of ≥ 3 using the FricTest® and a numerical rating scale score of ≥ 5 for itch after the provocation test.\n4. Cold induced urticaria: Positive ice-cube test resulting in hives at the provocation site during Screening\n5. Normal blood counts and liver function tests.\n6. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for ≥ 150 days after treatment.\n7. Willing and able to complete a daily symptom electronic diary and comply with study visits.\n8. Participants with and without prior biologic experience are eligible.\n\nKey Exclusion Criteria:\n\n1. Women who are pregnant or nursing.\n2. Clearly defined cause for chronic urticaria.\n3. Active, pruritic skin condition in addition to cold induced urticaria or symptomatic dermographism.\n4. Medical condition that would cause additional risk or interfere with study procedures.\n5. Known HIV, hepatitis B or hepatitis C infection.\n6. Vaccination with a live vaccine within 30 days prior to screening (subjects must agree to avoid vaccination with a live vaccine during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.\n7. History of anaphylaxis, unless due to cold exposure over a large part of the body (such as swimming in cold water).\n8. Prior treatment with barzolvolimab\n\nThere are additional criteria that your study doctor will review with you to confirm you are eligible for the study.",{"count":577,"type":22},240,[25],"The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.",[581,582,583,584],"Chronic Inducible Urticaria","Cold Urticaria","Cold-Induced Urticaria","Symptomatic Dermographism",[586,587,588,589,590,591,592,593,594],"Chronic Inducible urticaria","cold urticaria","cold-induced urticaria","ColdU","symptomatic dermographism,","SD","barzolvolimab","CDX0159","CDX-0159",{"date":405,"type":46},{"date":597,"type":46},"2026-01-15",{"date":599,"type":22},"2028-10",{"name":601,"class":53},"Celldex Therapeutics",73,{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":389,"minAge":18,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":23,"phases":612,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":627},"100609601","phase-3-a-clinical-study-of-sacituzumab-tirumotecan-mk-2870-in-combination-with-pembrolizumab-mk-3475-as-first-line-maintenance-treatment-of-cervical-cancer-mk-2870-036trofuse-036gog-3123engot-cx22-100609601","NCT07216703","A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036\u002FTroFuse-036\u002FGOG-3123\u002FENGOT-cx22)","A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036\u002FGOG-3123\u002FENGOT-cx22)","The main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix\n* Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics \\[FIGO\\]-2028 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and\u002For radiation)\n* If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy\n* If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load\n* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1\n* Has tumor programmed cell death ligand 1 expression of combined positive score ≥1\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has HIV infection with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has a 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* Has received prior systemic anticancer therapy other than what is specified in this protocol\n* Is currently receiving a strong inducer\u002Finhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT\n* Has a diagnosis of immunodeficiency\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis\n* Has 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 (ILD) that required steroids, has current pneumonitis\u002FILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments\n* Has a history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":611,"type":22},1023,[25],"Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body.\n\nResearchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells.\n\nThe goals of this study are to learn:\n\n* About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and\n* If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment",[615],"Cervical Cancer",[617,618,619,620],"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)","Trophoblast Cell Surface Antigen 2 (TROP2)",{"date":407,"type":46},{"date":623,"type":46},"2026-01-19",{"date":625,"type":22},"2031-10-29",{"name":106,"class":53},138,{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":221,"maxAge":19,"enrollmentInfo":636,"targetDuration":4,"studyType":23,"phases":638,"briefSummary":639,"conditions":640,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":641,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":648},"100607159","phase-3-an-induction-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-crohns-disease-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":637,"type":22},980,[25],"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.",[227],{"date":405,"type":46},{"date":643,"type":46},"2025-10-01",{"date":645,"type":22},"2029-05-14",{"name":647,"class":53},"Sanofi",301,{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":4,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":23,"phases":658,"briefSummary":659,"conditions":660,"keywords":664,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":665,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":671},"100590383","phase-3-a-clinical-study-of-sacituzumab-tirumotecan-sac-tmt-mk-2870-in-people-with-breast-cancer-mk-2870-032-100590383","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":657,"type":22},2400,[25],"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",[661,662,663],"Breast Neoplasms","Triple Negative Breast Neoplasms","HR Low-Positive\u002FHER2-Negative Breast Neoplasms",[617,618,619],{"date":407,"type":46},{"date":667,"type":46},"2025-06-30",{"date":669,"type":22},"2034-12-29",{"name":106,"class":53},310,""]