[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Regeneron Pharmaceuticals\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":652},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,85,0,25,[9,44,68,99,124,146,173,200,229,269,294,320,345,371,397,424,438,464,489,513,537,564,585,607,628],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100054215","phase-3-a-study-in-adult-patients-with-paroxysmal-nocturnal-hemoglobinuria-pnh-to-evaluate-how-safe-long-term-treatment-with-pozelimab--cemdisiran-combination-therapy-is-and-how-well-it-works-100054215",false,"NCT05744921","A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works","An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria","ACCESS-EXT","Key Inclusion Criteria:\n\nPatients Entering from the Parent Study\n\n1. Patients with PNH who have completed, without permanent discontinuation, study treatment in the parent study (R3918-PNH-2021\\[NCT05133531\\]), including the post-Open-label treatment period (OLTP) transition period, if applicable.\n2. Willing and able to comply with clinic visits and study-related procedures, including meningococcal vaccinations required per protocol.\n\nPatients Entering with C5 polymorphism\n\n1. Patients with PNH who have a documented C5 polymorphism rendering them refractory to eculizumab or ravulizumab (eg, p.Arg885His, p.Arg885Cys), as described in the protocol\n2. Diagnosis of PNH confirmed by high-sensitivity flow cytometry testing with PNH granulocytes or monocytes\n3. Active disease, as defined by the presence of 1 or more PNH-related sign or symptom as described in the protocol\n4. LDH level ≥2 × upper limit of normal (ULN) at the screening visit\n5. Willing and able to comply with clinic visits and study-related procedures, including meningococcal vaccinations required per protocol\n\nKey Exclusion Criteria:\n\nPatients Entering from the Parent Study\n\n1. Significant protocol deviation(s) in the parent study based on the investigator's judgment and to the extent that these would (if continued) impact the study objectives and\u002For safety of the patient\n2. Any new condition or worsening of an existing condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the study\n\nPatients Entering with C5 polymorphism\n\n1. Prior treatment with complement inhibitors within 5 half-lives of the respective agent prior to screening, except for prior eculizumab or ravulizumab which are not exclusionary\n2. Receipt of an organ transplant, history of bone marrow transplantation or other hematologic transplant\n3. Not meeting meningococcal vaccination requirements and, at a minimum, documentation of quadrivalent meningococcal vaccination within 5 years prior to enrollment and serotype B vaccine within 3 years prior to enrollment as described in the protocol\n4. Positive hepatitis B surface antigen or hepatitis C virus Ribonucleic acid (RNA) during screening\n5. Patients with known HIV with history of opportunistic infections in the last 1 year as described in the protocol\n6. Known hereditary complement deficiency\n7. Documented history of active, uncontrolled, ongoing systemic autoimmune diseases\n8. Documented history of liver cirrhosis or patients with liver disease with evidence of current impaired liver function or patients with elevations in Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) (unrelated to PNH or its complications) as described in the protocol\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply","ALL","18 Years",{"count":21,"type":22},202,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study is researching an experimental treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of this study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH in the long term. The pozelimab + cemdisiran combination may be referred to as \"study drugs\" in this section.\n\nThis study is looking at several other research questions, including:\n\n* How effective is the pozelimab + cemdisiran combination?\n* What side effects may happen from taking the study drugs?\n* How much of each study drug is in the blood at different times?\n* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)",[28],"Paroxysmal Nocturnal Hemoglobinuria",[30],"PNH","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2023-03-07",{"date":39,"type":22},"2029-02-26",{"name":41,"class":42},"Regeneron Pharmaceuticals","INDUSTRY",45,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100054279","phase-3-regn7508-versus-apixaban-and-enoxaparin-for-thromboprophylaxis-after-total-knee-arthroplasty-in-adults-100054279","NCT07015905","REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults","A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)","ROXI-APEX","Key Inclusion Criteria:\n\n1. Is undergoing a primary elective unilateral TKA\n2. Is in good health based on laboratory safety testing as described in the protocol\n3. Body weight ≤130 kg at screening visit as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation\n2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol\n3. History of thromboembolic disease or thrombophilia\n4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization\n5. Has an estimated Glomerular Filtration Rate (GFR) of \\\u003C30 mL\u002Fmin\u002F1.73 m2 at the screening visit as described in the protocol\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply",{"count":53,"type":22},2000,[25],"This study is researching an experimental drug called REGN7508 (called \"study drug\"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.\n\nThe aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)",[57],"Venous Thromboembolism (VTE)",[59,60],"Unilateral Total Knee Arthroplasty (TKA)","Factor XI (FXI)",{"date":34,"type":35},{"date":63,"type":35},"2025-06-25",{"date":65,"type":22},"2027-05-12",{"name":41,"class":42},46,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":18,"minAge":76,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100053985","phase-3-efficacy-and-safety-of-mibavademab-in-adult-and-pediatric-patients-with-generalized-lipodystrophy-100053985","NCT07220785","Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy","A Two-Part, Randomized, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Mibavademab in Patients With Generalized Lipodystrophy (LAGO)","LAGO","Key Inclusion Criteria:\n\n1\\. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines\n\nFor Part A only:\n\n1. Participants ≥2 years of age at screening\n2. At least one of the below criteria are fulfilled during screening (measurements can be repeated once during screening period)\n\n   * HbA1c ≥7%\n   * Fasting TG ≥500 mg\u002FdL\n   * Fasting TG value of ≥300 mg\u002FdL and the presence of another complication of GLD consistent with leptin deficiency (history of diabetes mellitus, hyperphagia, Metabolic Associated Fatty Liver Disease (MAFLD), polycystic ovary syndrome, etc)\n3. Weight ≥15 kg at screening\n4. Willing and able to provide, or have the treating physician provide, values of HbA1c and fasting TG from at least 6 months prior to screening, as described in the protocol\n\nFor Part B only:\n\n1. Participants \\\u003C12 years of age at screening\n2. Weighing ≥7 kg at screening\n3. No metabolic criteria for study entry is required, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Has a current diagnosis of familial or acquired partial lipodystrophy or autoimmune (Type 1) diabetes mellitus\n2. Any malignancy, eg, lymphoma, within the past 1 year, prior to screening visit, as described in the protocol\n3. eGFR of \\\u003C30 mL\u002Fmin\u002F1.73 m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine or Schwartz equation, as applicable, at screening. Assessment can be repeated once\n4. History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, as described in the protocol\n5. Treatment with over-the-counter or prescription medications with the intention of weight loss within 3 months prior to the screening visit\n\nFor Part A only:\n\n1. Treatment with metreleptin within 3 months of the screening visit\n2. Addition or discontinuation of prescription medications or over-the-counter supplements for diabetes and\u002For dyslipidemia within 3 months prior to the start of the screening period, or changes in the use of these medications, as described in the protocol\n3. Significant changes to lifestyle and diet, as described in the protocol\n4. Current chronic treatment with high-dose corticosteroids, defined as use of higher than physiologic doses, as described in the protocol\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply.","2 Years",{"count":78,"type":22},28,[25],"This study is researching a new drug called mibavademab (called \"study drug\"). The study involves participants with a condition called Generalized Lipodystrophy (GLD). The aim of the study is to see how well mibavademab works and what side effects it has. Researchers will also look at how much mibavademab is in the body at different times.\n\nThis is a 2-part study: Part A is an efficacy study in pediatric and adult participants, Part B is a safety and pharmacokinetic study in pediatric participants.\n\nThe study is researching several other questions, including:\n\n* How mibavademab affects the amount of sugar in the blood\n* How mibavademab affects the amount of fat (triglycerides) in the blood\n* How mibavademab affects the amount of fat that has built up in the liver\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)",[82],"Generalized Lipodystrophy",[84,85,86,87,88,89,90,91],"Subcutaneous (SC) adipose tissue","GLD","Berardinelli-Seip Syndrome","Congenital Generalized Lipodystrophy","CGL","Lawrence Syndrome","Acquired Generalized Lipodystrophy","AGL",{"date":34,"type":35},{"date":94,"type":35},"2026-03-13",{"date":96,"type":22},"2028-09-08",{"name":41,"class":42},3,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100054069","phase-3-venous-thromboembolism-vte-prophylaxis-with-regn7508-and-regn9933-in-adult-and-adolescent-participants-with-a-peripherally-inserted-central-catheter-picc-100054069","NCT07697599","Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)","A Master Protocol for a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, for Prophylaxis of Venous Thromboembolism in Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)","ROXI-PEAK","Key Inclusion Criteria:\n\n1. Is undergoing PICC placement for Intravenous (IV) administration of clinically indicated medications, including chemotherapy, antibiotics, TPN, and\u002For other indications as described in the protocol\n2. Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol\n3. Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol\n4. Weighs at least 40 kg during the screening period\n\nKey Exclusion Criteria:\n\n1. Has a history of prior venous thrombosis in the arm and\u002For ipsilateral thoracic central veins in which the PICC is to be placed\n2. Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis\n3. Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy\n4. Has current or history of known brain tumors or brain metastases\n5. Has any major cardiovascular event within approximately the past 30 days prior to study administration\n6. Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period\n\nNote: Other Protocol Defined Inclusion\u002F Exclusion Criteria Apply","15 Years",{"count":109,"type":22},1908,[25],"This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called \"study drugs\"). The study is focused on people who have a tube placed in a vein to receive treatment (called Peripherally Inserted Central Catheter \\[PICC\\]). Patients with PICCs have a higher risk of getting blood clots which can block the veins (this is called Venous Thromboembolism \\[VTE\\]) and lead to serious health problems or be life threatening.\n\nThe aim of the study is to see how well REGN7508 and REGN9933 prevent blood clots compared to placebo after PICC placement and to see if these medications cause certain types of bleeding.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)\n* If the study drugs affect the ability of the blood to clot normally",[57],[114,115],"Peripherally Inserted Central Catheter (PICC)","Blood clots","NOT_YET_RECRUITING","2026-07-06",{"date":34,"type":35},{"date":120,"type":22},"2026-08-20",{"date":122,"type":22},"2029-09-21",{"name":41,"class":42},{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100604840","phase-3-a-study-to-evaluate-how-pozelimab--cemdisiran-combination-therapy-works-in-adult-patients-with-paroxysmal-nocturnal-hemoglobinuria-pnh-whose-current-treatment-is-not-working-efficiently-100604840","NCT07154745","A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Whose Current Treatment is Not Working Efficiently","A Single Arm Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Control of Intravascular Hemolysis on Currently Available C5 Inhibitor Therapy","Key Inclusion Criteria:\n\n1. Diagnosis of PNH confirmed by a history of high-sensitivity flow cytometry from prior testing\n2. Currently treated with marketed eculizumab, ravulizumab, or crovalimab at the labeled dose for at least 6 months\n3. LDH persistently \\> 1.5 × Upper Limit of Normal (ULN) in the previous 6 months that the Principal Investigator (PI) attributes is due to intravascular hemolysis\n4. At least 2 screening LDH values from different visits as described in the protocol\n5. Willing and able to comply with clinic\u002Fremote visits and study-related procedures, including completion of the full series of meningococcal vaccinations required per protocol and agreement to continue to remain up to date with these vaccinations during the study\n\nKey Exclusion Criteria:\n\n1. Receipt of an organ transplant, history of bone marrow transplantation or other hematologic transplants\n2. Body weight \\\u003C40 kilograms at screening visit\n3. Patients with a known or suspected C5 mutation that is refractory to their current C5i treatment as described in the protocol\n4. Any active or ongoing infection within 2 weeks of screening or during the screening period or any recent infection as described in the protocol\n5. Known hereditary complement deficiency\n\nNote: Other protocol-defined Inclusion\u002F Exclusion Criteria apply",{"count":132,"type":22},35,[25],"This study is researching a treatment combination with two experimental drugs called pozelimab and cemdisiran referred to as \"study drugs\". Researchers are looking for a better way to treat Paroxysmal Nocturnal Hemoglobinuria (PNH).\n\nThe aim of the study is to see how well the pozelimab and cemdisiran combination works to lower hemolysis in participants whose PNH has been not well controlled even after taking other complement component 5 (C5) inhibitors, eculizumab\u002Feculizumab biosimilar, ravulizumab or crovalimab.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs?\n* How much of the study drugs are in the blood at different times?\n* Whether the body makes antibodies against the study drug (which could make the study drugs not work as well or could lead to side effects)",[28],[30],"2026-07-01",{"date":139,"type":35},"2026-07-02",{"date":141,"type":35},"2026-06-11",{"date":143,"type":22},"2031-12-04",{"name":41,"class":42},16,{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},"100629671","phase-2-a-study-to-see-how-safe-and-effective-alirocumab-is-when-given-weekly-to-adult-participants-who-have-hypercholesterolemia-100629671","NCT07477704","A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia","A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia","ASCEND-QW","Key Inclusion Criteria:\n\n1\\. Participant has elevated LDL-C level, as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Participant plans to initiate or change dose of lipid-lowering therapy\n2. Use of any PCSK9 inhibitors\n\nNOTE: Other Protocol-Defined Inclusion\u002FExclusion Criteria Apply","80 Years",{"count":156,"type":22},420,[158],"PHASE2","This study is researching an experimental drug called alirocumab, referred to as \"study drug\". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels).\n\nThe aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug once a week\n* How much study drug is in the blood at different times",[161],"Hypercholesterolemia",[163,164],"Obesity","Elevated Low-Density Lipoprotein Cholesterol (LDL-C) Levels","2026-06-30",{"date":137,"type":35},{"date":168,"type":35},"2026-06-17",{"date":170,"type":22},"2027-02-23",{"name":41,"class":42},6,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},"100610067","phase-3-a-study-to-compare-linvoseltamab-monotherapy-and-linvoseltamab--carfilzomib-combination-therapy-with-standard-of-care-combination-regimens-in-adult-participants-with-relapsedrefractory-multiple-myeloma-rrmm-100610067","NCT07222761","A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed\u002FRefractory Multiple Myeloma (RRMM)","An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed\u002FRefractory Multiple Myeloma","LINKER-MM5","Key Inclusion Criteria:\n\n1. Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody\n2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2\n3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy\n\nKey Exclusion Criteria:\n\n1. Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded\n2. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)\n3. Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement\n4. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply",{"count":182,"type":22},915,[25],"This study is researching a drug called linvoseltamab (also called \"study drug\") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies.\n\nThe aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)",[186],"Relapsed and\u002For Refractory Multiple Myeloma (RRMM)",[188,189,190,191,192],"BCMA X CD3 Bispecific Monoclonal Antibody","Bispecific combination therapy","Linvoseltamab","Carfilzomib","Proteasome inhibitor",{"date":137,"type":35},{"date":195,"type":35},"2026-01-02",{"date":197,"type":22},"2034-08-23",{"name":41,"class":42},20,{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},"100561073","phase-3-study-of-intralesional-cemiplimab-in-adult-patients-with-early-stage-cutaneous-squamous-cell-carcinoma-100561073","NCT06585410","Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma","A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)","Key Inclusion Criteria:\n\n1. Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol\n2. Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) located in either the Head or Neck (HN), hand, or pre-tibial surface, as described in the protocol\n3. Participants who are judged to be eligible for surgical resection of their CSCC TL and the method of planned surgical resection would be Micrographically oriented histographic surgery (Mohs) or other surgical method of Complete Margin Assessment (CMA). Participants for whom the planned surgery is surgical excision without margin control are not eligible\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1\n5. Adequate hepatic, renal and bone marrow functions, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, sarcomatoid carcinoma, basal cell carcinoma, basosquamous carcinoma, Bowen's disease, or CSCC in situ without an invasive component. (Note: For participants with invasive CSCC with a minor basaloid component, the patient may be eligible after discussion with the sponsor medical director.)\n2. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated Adverse Events (imAEs), as described in the protocol\n3. History of non-infectious pneumonitis within the last 5 years\n4. TL (lesion planned for intralesional therapy) or other non-target CSCC lesion in dry red lip (vermillion), oral cavity, or nasal mucosa\n\nNOTE: Other protocol defined inclusion \u002F exclusion criteria apply.",{"count":208,"type":22},369,[25],"This study will test a study drug called cemiplimab to see if it can help treat early-stage Cutaneous Squamous Cell Carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called Programmed cell Death-1 (PD-1) on the surface of certain immune cells.\n\nThe main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion.\n\nThe study is looking at:\n\n* The side effects cemiplimab might cause\n* How well cemiplimab works compared to surgery",[212],"Cutaneous Squamous Cell Carcinoma (CSCC)",[214,215,216,217,218,219,220],"Dermato-Oncology","Cemiplimab","Early Stage","Skin Cancer","Non-Melanoma Skin Cancer","UV Skin Damage","Chronic Sun Exposure","2026-06-29",{"date":165,"type":35},{"date":224,"type":35},"2025-01-02",{"date":226,"type":22},"2030-05-03",{"name":41,"class":42},52,{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":145},"100499844","phase-1-a-study-of-db-oto-an-adeno-associated-virus-aav-based-gene-therapy-in-childreninfants-adolescents-and-adults-with-hearing-loss-due-to-otoferlin-mutations-100499844","NCT05788536","A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children\u002FInfants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations","A Phase 1\u002F2, Open-Label, Multicenter Trial With a Single Ascending Dose Cohort With Unilateral Intracochlear Injection Followed by a Bilateral Injection Expansion Cohort to Evaluate the Safety, Tolerability, and Efficacy of DB-OTO in Children and Infants With Biallelic hOTOF Mutations","CHORD","Key Inclusion Criteria:\n\n1. Willingness to provide written informed consent (by at least one parent\u002Flegal guardian for pediatric participants, and with participant to provide assent, when applicable, or by the adult participant) and willingness to comply with trial protocol\n2. Willingness to consent to genetic testing for the participant (by at least one parent\u002Flegal guardian for pediatric participants, and with participant to provide assent, when applicable, or by the adult participant) in order to evaluate a panel of hearing loss-related genes\n3. Willingness to consent to vaccinations for the participant (by at least one parent\u002Flegal guardian for pediatric participants, and with participant to provide assent, when applicable, or by the adult participant) in accordance with the country-specific, age-appropriate immunization schedule, as described in the protocol\n4. Participant able to perform all necessary assessments to qualify for enrollment and dosing in the corresponding cohort at the time the participant or parent\u002Flegal guardian signing the informed consent form (and participant providing assent, when applicable)\n5. Presence of biallelic, likely pathogenic or pathogenic OTOF variants\n6. No clinically significant laboratory findings on clinical laboratory tests at time of Screening as described in the protocol\n7. Audiological Criteria:\n\n   1. Investigator diagnoses the participant with profound sensorineural hearing loss (SNHL; \\>90 dB HL) based on behavioral and physiologic measurements (ABR) of inner ear function\n   2. Outer hair cell presence is confirmed via presence of otoacoustic emissions (≥6 dBSNR) at ≥3 frequencies from 1 to 8 kHz in the ear(s) to be infused with DB-OTO. Alternatively, for participants \\>24 months of age, outer hair cell presence can be confirmed via presence of the cochlear microphonic in the ear(s) to be infused with DB-OTO.\n8. No evidence from measures of hearing loss that show a dependence on body temperature\n9. From study start and for the duration of the short-term follow-up period (48 weeks): Female participants of childbearing potential and fertile males, must agree to use highly effective contraception. Female participants must agree not to become pregnant. Fertile male participants must agree not to father a child or donate sperm, for 48 weeks and in cases of early withdrawal, for at least 12 months after DB-OTO administration.\n\nKey Exclusion Criteria:\n\n1. History of prior treatment with gene therapy\n2. Surgical anatomy that would preclude or meaningfully impact the planned surgical approach as indicated by medical imaging (eg, Computed Tomography \\[CT\\] or Magnetic Resonance Imaging \\[MRI\\]) in the ear(s) to be infused with DB-OTO\n3. History or presence of other permanent or untreatable hearing loss conditions\n4. Prior or current history of malignancies\n5. Prior or current history of meningitis\n6. History or presence of cochlear implants in the ear(s) to be infused with DB-OTO\n7. History of risk factor(s) for auditory neuropathy not caused by OTOF pathogenic variants including but not limited to: prematurity, low birth weight, hyperbilirubinemia, Neonatal Intensive Care Unit (NICU) admission, and\u002For low Apgar scores as described in the protocol\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria apply",{"count":238,"type":22},36,[240,158],"PHASE1","Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat pediatric and adult participants who have severe-to profound and profound hearing loss due to changes in the otoferlin gene.\n\nThe purpose of this study is to:\n\n* Learn about the safety of DB-OTO\n* Determine how well DB-OTO is tolerated (does not cause ongoing discomfort)\n* Evaluate the efficacy of DB-OTO (how well DB-OTO works)",[243],"Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)",[245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,235],"DB-OTO","Gene Therapy","Congenital Hearing Loss","Sensorineural Hearing Loss","Auditory Neuropathy","Pediatric","Cochlear Implant","Otoferlin","Deaf","Hard of hearing","Hearing impaired","Hearing disorder","Fully implantable hearing aid","Child","Infant","Adolescents","Young Adults","Adults",{"date":137,"type":35},{"date":265,"type":35},"2023-06-27",{"date":267,"type":22},"2032-02-25",{"name":41,"class":42},{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":276,"minAge":19,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":293},"100634697","phase-1-a-phase-1-study-of-bpx-601-car-t-cell-therapy-in-adult-participants-with-prostate-cancer-that-has-returned-is-resistant-to-treatment-and-has-spread-100634697","NCT07543055","A Phase 1 Study of BPX-601 CAR T-Cell Therapy in Adult Participants With Prostate Cancer That Has Returned, is Resistant to Treatment and Has Spread","A Phase 1, Open-Label, Dose-Escalation Study of BPX-601, an Anti-PSCA CAR T Cell Drug Product, in Relapsed\u002FRefractory Metastatic Castration-Resistant Prostate Cancer","Key Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of hormone-refractory adenocarcinoma of the prostate without pure small cell carcinoma\n2. Metastatic, Castration-Resistant Prostate Cancer (mCRPC) with PSA value at screening ≥4 ng\u002FmL that has progressed within 6 months prior to screening, as defined in the protocol\n3. Has received ≥2 lines prior systemic therapy approved in the metastatic and\u002For castration-resistant setting \\[in addition to Androgen Deprivation Therapy (ADT)\\] including at least 1 second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)\n4. Has had either orchiectomy OR is on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone \\\u003C50 ng\u002FdL AND agrees to stay on LHRH agonist or antagonist therapy during the study\n\nKey Exclusion Criteria:\n\n1. Structurally unstable bone lesions suggesting impending fracture\n2. Clinical or radiographic evidence of deep vein thrombosis, pulmonary embolism, or other known thromboembolic event that has not been definitively treated. Participants with prior history of coagulopathy must be on low-molecular weight heparin prophylaxis or prophylactic dose of oral anticoagulant and asymptomatic within 4 weeks of the planned BPX-601 infusion\n3. Inadequate renal function defined by creatinine clearance \\\u003C60 mL\u002Fmin calculated by 24-hour urine collection or using the Cockcroft-Gault formula\n4. Inadequate hepatic function defined by Aspartate aminotransferase (AST) and\u002For Alanine aminotransferase (ALT) \\>2.5 × ULN or \\>5 × ULN, if liver metastases, and\u002For total bilirubin \\>1.5 × ULN, as described in the protocol\n5. Inadequate bone marrow function defined by Absolute Neutrophil Count (ANC) \\\u003C1.5 × 10\\^9\u002FL or platelet count \\\u003C150 × 10\\^9\u002FL. At least 7 days must have passed since the last dose of filgrastim (or 14 days since the last dose of pegfilgrastim) and at least 7 days must have passed since the last platelet transfusion at the time of ANC or platelet count.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria apply","MALE",{"count":238,"type":22},[240],"This study will test a study drug called BPX-601, a CAR-T cell product manufactured from the patient's own T-cells, to see if it can help treat advanced prostate cancer. BPX-601 is a drug that is only used in clinical studies.\n\nThe study is looking at:\n\n* What side effects BPX-601 might cause\n* What is the best dose of BPX-601\n* How well BPX-601 may work to destroy prostate cancer",[281],"Prostate Cancer",[283,284,285],"Relapsed\u002FRefractory (R\u002FR)","Metastatic","Castration-Resistant","2026-06-26",{"date":165,"type":35},{"date":289,"type":22},"2026-07-07",{"date":291,"type":22},"2031-04-25",{"name":41,"class":42},1,{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":154,"enrollmentInfo":302,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":308,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},"100613791","phase-2-study-to-assess-the-effects-of-angiopoietin-like-protein-3-angptl3-inhibition-in-adult-participants-with-diabetic-kidney-disease-100613791","NCT07271186","Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease","A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of ANGPTL3 Inhibition With Either Small-Interfering RNA Alone or in Combination With an ANGPTL3 Antibody in Participants With Diabetic Kidney Disease","ANCHOR-POC","Key Inclusion Criteria:\n\n1. Medical history of type 2 diabetes and receiving medical therapy or lifestyle interventions for glucose management\n2. Hemoglobin A1C (HbA1c) of 6.5 to 10% at screening\n3. eGFR 30 to 90 mL\u002Fmin\u002F1.73 m\\^2 using 2021 Chronic Kidney Disease-Epidemiology Collaboration-Estimated Glomerular Filtration Rate using Creatinine and Cystatin C (CKD-EPI eGFRcr-cys) equation at screening\n4. Albuminuria: Urine Albumin to Creatinine Ratio (UACR) of 500 to 5000 mg\u002Fg at screening\n\nKey Exclusion Criteria:\n\n1. Known medical history or clinical evidence indicative of non-diabetic renal disease\n2. Renal disease that required treatment with systemic immunosuppressive therapy, or a history of dialysis or renal transplant\n3. Medically unstable as assessed by the investigator\n4. Hospitalization (ie, \\>24 hours) within 30 days of the screening visit\n\nNOTE: Other Protocol-Defined Inclusion\u002FExclusion Criteria Apply",{"count":303,"type":22},270,[158],"This study is researching experimental drugs called ALN-ANG3 and evinacumab (called \"study drugs\"). The study is focused on participants who have diabetic kidney disease.\n\nThe aim of the study is to see how safe and effective the study drugs are.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times",[307],"Diabetic Kidney Disease (DKD)",[309,310,311],"Chronic Kidney Disease (CKD)","Type 2 Diabetes","Lipid Management","2026-06-24",{"date":286,"type":35},{"date":315,"type":35},"2026-01-09",{"date":317,"type":22},"2028-04-07",{"name":41,"class":42},53,{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":344},"100575239","phase-2-a-study-to-see-if-giving-fianlimab-and-cemiplimab-together-is-better-than-cemiplimab-alone-at-treating-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-100575239","NCT06769698","A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma","Phase II Randomized Study of Fianlimab Plus Cemiplimab Versus Cemiplimab Plus Placebo in First-Line Treatment of Participants With Recurrent or Metastatic (R\u002FM) Head and Neck Squamous Cell Carcinoma (HNSCC) That Is Positive for PD-L1 Expression","Key Inclusion Criteria:\n\n1. Have histologically confirmed (by local pathology) R\u002FM HNSCC that is considered incurable by local therapies\n2. Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx (patients with cervical neck node SCC with occult primary as described in the protocol\n3. PD-L1 expression Combined Positive Score (CPS) ≥1 documented with a previously PD-L1 obtained Immunohistochemistry (IHC) result prior to screening, as described in protocol\n4. Oropharynx cancer participants only: HPV status, based on a previously documented result prior to screening, must have been established in a surgical biopsy specimen or a core biopsy specimen as described in the protocol\n5. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as described in the protocol\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Adequate organ and bone marrow function as described in the protocol\n\nKey Exclusion Criteria:\n\nMedical Conditions\n\n1. Participants who have Progressive Disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC as described in the protocol\n2. Participants who have a primary tumor site of nasopharynx, paranasal sinus or salivary gland (any histology)\n3. Head and neck SCC with unknown primary site as described in the protocol\n4. Participants with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date as described in the protocol\n5. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management\n6. History or current evidence of significant cardiovascular disease including, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classification III and IV), unstable angina, serious uncontrolled arrhythmia, and myocardial infarction 6 months prior to study enrollment.\n\n   Prior\u002FConcomitant Therapy\n7. Participants who have received prior systemic anticancer therapy in the R\u002FM HNSCC setting as described in the protocol\n8. Participants with a condition requiring corticosteroid therapy (\\>10 mg prednisone\u002Fprednisolone\u002Fday or equivalent) within 14 days of the first dose of study drug as described in the protocol\n\nNote: Other protocol defined Inclusion\u002F Exclusion Criteria apply",{"count":328,"type":22},120,[158],"This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not contain any real medicine), collectively called \"study drugs\" in this form.\n\nThe study is focused on participants with head and neck cancers who have not been previously treated for head and neck cancer that has come back or spread to other parts of the body, referred to as recurrent or metastatic (R\u002FM) head and neck squamous cell carcinoma (HNSCC).\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs\n* How much of each study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug(s) individually (which could make the study drugs less effective or could lead to side effects)\n* Compatible research to better understand the study drugs and HNSCC",[332],"Head and Neck Squamous Cell Carcinoma (HNSCC)",[334,335,336],"Recurrent or Metastatic (R\u002FM)","Positive for Programmed Death Ligand 1 (PD-L1) Expression","Human Papillomavirus (HPV)",{"date":338,"type":35},"2026-06-25",{"date":340,"type":35},"2026-04-14",{"date":342,"type":22},"2030-12-28",{"name":41,"class":42},21,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":4},"100644992","phase-1-regn22530-for-adults-with-primary-open-angle-glaucoma-or-ocular-hypertension-100644992","NCT07675824","REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension","A Phase 1\u002F2 Study of REGN22530 in Participants With Primary Open Angle Glaucoma or Ocular Hypertension","BAHAMA","Key Inclusion Criteria:\n\n1. Diagnosis of OHT or POAG of mild to moderate severity as described in the protocol\n2. Best-Corrected Visual Acuity (BCVA) of ≥35 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen equivalent of better than or equal to 20\u002F200) in the study eye on day 1\n3. BCVA of ≥55 EDTRS letters (Snellen equivalent of better than or equal to 20\u002F80) in the non-study eye on day 1\n4. Phakic or pseudophakic with a posterior chamber intraocular lens that has been implanted ≥3 months prior to Screening Visit 1\n5. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality posterior segment imaging in the study eye\n\nKey Exclusion Criteria:\n\nOcular-specific exclusion criteria apply to the Study Eye only, unless otherwise specified.\n\n1. OAG or OHT secondary to pigment dispersion, pseudoexfoliation, trauma, uveitis, neovascularization, a vascular disorder, or steroid use\n2. Congenital or traumatic cataract, or visually significant cataract that is likely to require surgical intervention during the study\n3. Presence of significant corneal scarring or irregularities that could interfere with reliable IOP measurement\n4. Prior incisional or bleb-forming glaucoma surgery, suprachoroidal procedures, Trabecular Meshwork (TM)-stripping Microinvasive Glaucoma Surgery (MIGS), angle-based implants other than iStent or iridectomy\u002Firidotomy as described in the protocol\n5. History of Selective Laser Trabeculoplasty (SLT) within 6 months prior to day 1\n6. History of transscleral (including micropulse) or endoscopic cyclophotocoagulation within 1 year prior to day 1\n\nNote: Other protocol defined Inclusion\u002F Exclusion criteria apply",{"count":354,"type":22},271,[240,158],"This study will test an experimental drug called REGN22530 (\"study drug\") to see if it can help treat people with primary open angle glaucoma or ocular hypertension. REGN22530 is an experimental drug that is designed to bind with a protein in the eye that has been shown to cause a buildup of fluid inside the eye and cause increased Intraocular Pressure (IOP).\n\nREGN22530 attaches to this protein and stops it from working which may allow more fluid to drain out of the eye and decrease the pressure.\n\nThe study is looking at:\n\n* What side effects REGN22530 might cause\n* How much REGN22530 is in the blood and eye fluid at different times\n* If the body has any reactions to REGN22530 (which may cause REGN22530 to not work as well)\n* How the body and eye pressure respond after having REGN22530, which can help researchers understand why REGN22530 works better in some people than others\n* How well REGN22530 works",[358,359],"Primary Open Angle Glaucoma (POAG)","Ocular Hypertension (OHT)",[361,362,363],"Intraocular Pressure (IOP)","First in Human (FIH)","Open Angle Glaucoma (OAG)","2026-06-23",{"date":165,"type":35},{"date":367,"type":22},"2026-07-23",{"date":369,"type":22},"2029-10-16",{"name":41,"class":42},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":18,"minAge":378,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":23,"phases":381,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":4},"100644994","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-fel-d-1-monoclonal-antibodies-in-adult-and-pediatric-participants-with-allergic-conjunctivitis-due-to-cat-allergy-100644994","NCT07675811","A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy","A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Cat Allergy","Key Inclusion Criteria:\n\n1. Part A: adult participants aged 18 years and older. For part B: pediatric participants ≥8 years and \\\u003C18 years, and adult participants aged 18 years and older.\n2. Positive SPT to cat allergen extract\n3. Positive specific Immunoglobulin E (sIgE) tests for cat and Fel d 1\n4. Positive CAC criteria\n\nKey Exclusion Criteria:\n\n1. Significant and\u002For severe environmental allergies causing symptoms (eg, ocular itching, ocular redness, etc) outside of the challenge setting that are expected to coincide or may interfere with study assessments\n2. Presence of any ophthalmic disease\u002F abnormality\u002F condition that may interfere with study assessments, affect the study outcomes or participant safety\n3. A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment as defined in the protocol\n\nNote: Other Protocol Defined Inclusion\u002F Exclusion Criteria Apply","8 Years",{"count":380,"type":22},570,[25],"This study is researching two experimental medicines, freneslerbart and mevonlerbart. Freneslerbart and mevonlerbart can be given alone or together. When given together, the medicine is called \"REGN-2Cat\". These medicines are also known as the \"study drugs\".\n\nThe aim of the study is to see what side effects freneslerbart, mevonlerbart, and REGN-2Cat may have and if they help reduce eye allergy symptoms caused by cat hair\u002Fdander compared with a placebo.\n\nThe study is looking at several other research questions, including:\n\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)\n* How long the study drug effect lasts",[384],"Allergic Conjunctivitis",[386,387,388,389,390],"Cat allergy","Eye allergy","Cat-induced eye allergy","Ocular allergy signs\u002Fsymptoms","Allergic conjunctivitis signs\u002Fsymptoms",{"date":165,"type":35},{"date":393,"type":22},"2026-07-27",{"date":395,"type":22},"2028-06-30",{"name":41,"class":42},{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":404,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":423},"100633532","phase-2-a-phase-2a-study-of-aln-pnp-with-and-without-a-glp1r-agonist-in-adult-patients-with-homozygous-pnpla3-related-masld-100633532","NCT07527910","A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD","A Two-Part, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of ALN-PNP With and Without a GLP1R Agonist in Adults With Homozygous PNPLA3-Related Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Key Inclusion Criteria:\n\nPart A and Part B:\n\n1. Homozygous for the PNPLA3 p.I148M genotype\n2. Liver fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥15% at visit 3\n3. Has a Body Mass Index (BMI) ≥30 to \\\u003C45 kg\u002Fm\\^2 at visit 2\n\nPart A: To be eligible for randomization on study day 1:\n\n1. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3 × Upper Limit of Normal (ULN) as described in the protocol\n2. On a stable dose of tirzepatide at randomization (≥5 mg weekly)\n\nKey Exclusion Criteria:\n\n1. Evidence or diagnosis of portal hypertension or cirrhosis from any cause, including cirrhosis due to MASH, as determined by the investigator, based on medical history, clinical assessment, imaging, and\u002For liver biopsy\n2. Known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol\n3. Contraindications to MRI examinations, including but not limited to persons with MRI-incompatible cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions\n4. Any contraindication listed in the Zepbound United States Prescribing Information (USPI), as defined in the protocol\n\nNOTE: Other protocol-defined inclusion\u002Fexclusion criteria apply.","75 Years",{"count":406,"type":22},204,[158],"This study will test a study drug called ALN-PNP with and without another drug that is used for controlling blood sugar, appetite, and weight (for example, tirzepatide), to see if it can help treat MASLD, also known as fatty liver disease. ALN-PNP reduces the amount of Patatin-like phospholipase domain-containing protein 3 (PNPLA3), a protein that liver cells make, which may help decrease liver fat if there is an abnormal PNPLA3 protein.\n\nThe goal of this study is to understand the effect of ALN-PNP with or without tirzepatide on reducing liver fat.\n\nThe study is looking at:\n\n* How well ALN-PNP with and without tirzepatide works\n* What side effects ALN-PNP might cause\n* How much ALN-PNP is in the blood at different times\n* How the body and the liver change after having ALN-PNP, which can help researchers understand why ALN-PNP works better in some people than others",[410],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)",[412,413,414,415,416],"Homozygous PNPLA3-Related MASLD","Fatty Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","Nonalcoholic Steatohepatitis (NASH)",{"date":286,"type":35},{"date":419,"type":35},"2026-05-22",{"date":421,"type":22},"2030-03-15",{"name":41,"class":42},5,{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":431,"phases":4,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":435,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":436,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":437,"locationsCount":4},"100564630","expanded-access-of-dupilumab-in-adults-with-severe-immunoglobulin-e-ige-mediated-food-allergy-previously-treated-with-linvoseltamab-100564630","NCT06631677","Expanded Access of Dupilumab in Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy Previously Treated With Linvoseltamab","An Open Label, Expanded Access Program of Dupilumab in Adults With Severe IgE-Mediated Food Allergy Who Have Been Previously Treated With Linvoseltamab and Background Dupilumab","Key Inclusion Criteria\n\n1. Eligible participants for this program consist of adults who have completed the End of Study (EOS) visit in the parent phase 1 study, R5458-668-ALG-2219 (NCT06369467)\n2. Administration of first dose of EAP dupilumab occurs as defined in the protocol\n\nKey Exclusion Criteria\n\n1. Participants who, during the parent study (R5458-668-ALG-2219 \\[NCT06369467\\]), developed a Serious Adverse Event (SAE) and\u002For Adverse Event (AE) as defined in the protocol\n2. Any temporary discontinuation of study drug dupilumab lasting \\>2 weeks during the parent study R5458-668-ALG-2219 (NCT06369467)\n3. Greater than 2 weeks since last administration of study drug dupilumab from the parent study R5458-668-ALG-2219 (NCT06369467)\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply.","EXPANDED_ACCESS","This is an expanded access program of dupilumab. The objective of the program is to provide continued dupilumab to adult participants with severe IgE-mediated food allergy who were previously treated with a short course of linvoseltamab and background dupilumab in the parent study R5458-668-ALG-2219 (NCT06369467).",[434],"Food Allergy","AVAILABLE",{"date":286,"type":35},{"name":41,"class":42},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":446,"sex":18,"minAge":19,"maxAge":447,"enrollmentInfo":448,"targetDuration":4,"studyType":23,"phases":450,"briefSummary":451,"conditions":452,"keywords":455,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":461,"leadSponsor":463,"locationsCount":293},"100633533","phase-1-first-in-human-trial-to-assess-regn20423-in-healthy-adult-participants-and-adult-participants-with-atopic-dermatitis-100633533","NCT07527923","First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis","A Two-Part Phase 1, Randomized, Double-Blind, Placebo-Controlled First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN20423 in Adult Healthy Participants and Adult Participants With Atopic Dermatitis","AURA-AD","Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis\n\nKey Inclusion Criteria:\n\nPart A:\n\n1. Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention\n2. Has a BMI within 18 to 31 kg\u002Fm² (inclusive) at the screening visit\n\n   Part B:\n3. Has a history of AD for at least 6 months at screening\n4. Has EASI score ≥5 at both the screening and baseline visits\n5. Has IGA score ≥2 at both the screening and baseline visits\n\nKey Exclusion Criteria\n\nPart A:\n\n1. Hospitalized (\\>24 hours) for any reason within 30 days prior to the screening visit\n2. Hypersensitivity to the study treatment or any of its excipients\n3. History of clinical parasite infection, except treated trichomoniasis\n4. Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study\n5. History of alcohol or drug abuse as determined by the investigator\n\n   Part B:\n6. Known or suspected history of immunosuppression\n7. Presence of skin comorbidities at screening that may interfere with study assessments\n8. Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list\n9. Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study\n\nNote: Other protocol defined Inclusion\u002F Exclusion criteria apply",true,"65 Years",{"count":449,"type":22},144,[240],"This study will test a study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B). REGN20423 is a study medicine that is only used in clinical studies. REGN20423 has not previously been studied in humans.\n\nThe study is looking at:\n\n* What side effects REGN20423 might cause\n* How much REGN20423 is in the blood at different times\n* How well REGN20423 works in adults with atopic dermatitis\n* Whether the body makes antibodies against REGN20423\n* How the body changes after having REGN20423, which can help researchers understand why REGN20423 works better in some people than others\n* What the best dose of REGN20423 is",[453,454],"Healthy Volunteer","Atopic Dermatitis",[456,457],"Eczema","Inflammatory skin disease","2026-06-22",{"date":338,"type":35},{"date":419,"type":35},{"date":462,"type":22},"2028-06-23",{"name":41,"class":42},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":474,"briefSummary":475,"conditions":476,"keywords":478,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":482,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":488},"100626078","phase-3-stroke-and-systemic-embolism-prevention-in-adult-participants-with-atrial-fibrillation-for-whom-oral-anticoagulation-is-unsuitable-100626078","NCT07430956","Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable","A Master Protocol for a Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, Versus Placebo in Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (ROXI-INCLINE)","ROXI-INCLINE","Key Inclusion Criteria:\n\n1. Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause\n2. At moderate to high risk for stroke defined as:\n\n   1. CHA2DS2-VA \\[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years\\] score ≥4 OR\n   2. CHA2DS2-VA score of 3 AND at least 1 enrichment criteria as described in the protocol\n3. Shared decision making between the participant and provider determining that the bleeding risk of Oral Anticoagulant (OAC) therapy outweighs the benefits, making the participant unsuitable for OAC therapy as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)\n2. Had an ischemic stroke within 2 days prior to randomization\n3. Has persistent, uncontrolled hypertension (per investigator's discretion)\n4. Has a history of Central Nervous System (CNS) bleeding within 30 days prior to randomization\n5. Has a life expectancy less than 12 months\n6. Has participated in a prior Factor XI (FXI) inhibitor study\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply",{"count":473,"type":22},2628,[25],"This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called \"study drugs\"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in one spot, which can lead to the formation of blood clots.\n\nREGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how effective and safe REGN7508 and REGN9933, individually, are in preventing ischemic stroke or systemic embolism in people with atrial fibrillation who cannot or may choose to not take blood thinners.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking REGN7508 or REGN9933\n* How well does REGN7508 or REGN9933 lower the risk of having an ischemic stroke and\u002For systemic embolism compared to the placebo\n* How well does REGN7508 or REGN9933 lower the risk of having a major health problem affecting heart and blood circulation compared to placebo\n* How well does REGN7508 or REGN9933 lower the risk of death compared to placebo\n* How much REGN7508 or REGN9933 is in the blood at different times\n* Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the study drugs less effective or could lead to side effects)",[477],"Atrial Fibrillation (AF)",[115,479,480,481,57],"Ischemic stroke","Systemic embolism","Pulmonary embolism",{"date":364,"type":35},{"date":484,"type":35},"2026-04-03",{"date":486,"type":22},"2029-06-26",{"name":41,"class":42},18,{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":18,"minAge":496,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":499,"briefSummary":500,"conditions":501,"keywords":502,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":512},"100616732","phase-3-study-of-bet-v1-antibodies-effect-on-eye-allergy-symptoms-in-adolescents-and-adults-with-birch-pollen-allergy-100616732","NCT07309432","Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy","A Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Bet v 1 Monoclonal Antibodies in Participants With Allergic Conjunctivitis Due to Birch Pollen Allergy","Key Inclusion Criteria:\n\n1. Positive SPT to birch allergen extract\n2. Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1\n3. Positive CAC criteria\n\nKey Exclusion Criteria:\n\n1. Significant and\u002For severe environmental allergies causing symptoms (outside of the challenge setting) that are expected to interfere with study assessments\n2. Presence of any ophthalmic disease\u002Fabnormality\u002Fcondition that may interfere with study assessments, affect the study outcomes or negatively impact participant safety\n3. A clinical history of asthma with treatment of asthma requiring systemic (oral or parenteral) corticosteroid treatment more than twice within prior 12 months or once within 3 months prior to screening visit 1 or has been hospitalized or has attended the Emergency Room\u002FUrgent Care facility for asthma in the 12 months prior to screening\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria apply.","12 Years",{"count":498,"type":22},350,[25],"This study is researching 2 experimental drugs, REGN5713 and REGN5715. The study drugs will be either of these drugs given alone (either REGN5713 or REGN5715) or given together (REGN5713 and REGN5715) to reduce eye allergy signs and symptoms due to birch tree pollen allergy.\n\nThe aim of the study is to see how safe and effective the study drugs are at lowering eye allergy signs and symptoms compared with placebo.\n\nThe study will also evaluate whether the combination (REGN5713-5715) has different effectiveness than REGN5713 or REGN5715 alone.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs\n* How much of the study drugs is in the blood at different times\n* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)",[384],[503,504,505],"Birch Pollen Allergy","Ocular allergy symptoms","Ocular allergy signs",{"date":364,"type":35},{"date":508,"type":35},"2026-01-10",{"date":510,"type":22},"2027-06-15",{"name":41,"class":42},2,{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":520,"minAge":19,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":529,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":319},"100576616","phase-2-investigation-of-ubamatamab-combination-therapy-in-adult-participants-with-platinum-resistant-ovarian-cancer-100576616","NCT06787612","Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer","Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer","Key Inclusion Criteria:\n\n1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)\n2. Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n4. Adequate organ and bone marrow function, as described in the protocol\n5. Platinum-Resistant Ovarian Cancer, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)\n2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)\n3. Another malignancy that is progressing or requires active treatment, as described in the protocol\n4. Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol\n5. Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency\n6. Moderate to large or ascites, as described in the protocol\n7. Bowel obstruction within last 3 months or current need for parenteral nutrition\n\nNOTE: Other protocol-defined inclusion\u002Fexclusion criteria apply","FEMALE",{"count":522,"type":22},220,[158],"This study is researching an experimental drug called ubamatamab, also referred to as \"study drug\". The study is focused on patients who have advanced ovarian cancer.\n\nThe aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab and a standard chemotherapy drug, pegylated liposomal doxorubicin \\[PLD\\]), referred to as \"combination drugs'.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug and its experimental combinations\n* How much study drug and fianlimab is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations",[526,527,528],"Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer",[530],"Platinum Resistance",{"date":364,"type":35},{"date":533,"type":35},"2025-05-28",{"date":535,"type":22},"2028-10-30",{"name":41,"class":42},{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":23,"phases":547,"briefSummary":548,"conditions":549,"keywords":551,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":563},"100523102","phase-3-a-trial-to-learn-if-odronextamab-is-safe-and-well-tolerated-and-how-well-it-works-compared-to-rituximab-combined-with-different-types-of-chemotherapy-for-adult-participants-with-previously-untreated-follicular-lymphoma-100523102","NCT06091254","A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma","A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)","OLYMPIA-1","Key Inclusion Criteria:\n\n1. Diagnosis of Cluster of Differentiation 20\\^+ (CD20\\^+) FL Grade 1-3a, stage II bulky or stage III \u002F IV\n2. Need for treatment as described in the protocol\n3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n5. Adequate bone marrow function and hepatic function, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma\n2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma\n3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma\n4. Treatment with any systemic anti-lymphoma therapy\n5. Infections and allergy\u002Fhypersensitivity to study drug or excipient, as described in the protocol\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply",{"count":546,"type":22},822,[25],"This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL).\n\nThis study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled).\n\nThe aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone.\n\nThe aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the \"comparator drug\") and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)\n* How the study drug affects quality of life and ability to complete routine daily activities.",[550],"Follicular Lymphoma (FL)",[552,553,554,555,556],"Non-Hodgkin lymphomas (NHLs)","Indolent NHL","B-cells NHL (B-NHL)","Follicular lymphoma","Odronextamab",{"date":312,"type":35},{"date":559,"type":35},"2023-12-12",{"date":561,"type":22},"2029-11-03",{"name":41,"class":42},190,{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":23,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":584},"100360402","phase-1-a-trial-to-find-out-if-regn5678-nezastomig-is-safe-and-how-well-it-works-alone-or-in-combination-with-cemiplimab-for-adult-participants-with-metastatic-castration-resistant-prostate-cancer-and-other-tumors-100360402","NCT03972657","A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors","A Phase 1\u002F2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression","Key Inclusion Criteria:\n\nmCRPC cohorts (men):\n\n1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.\n2. PSA value at screening ≥4 ng\u002FmL that has progressed within 6 months prior to screening as defined in the protocol.\n3. Has received ≥2 lines prior systemic therapy approved in the metastatic and\u002For castration-resistant setting (in addition to Androgen Deprivation Therapy \\[ADT\\]) including at least:\n\n   1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)\n   2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol\n\nccRCC cohorts (men and women):\n\n1. Histologically or cytologically confirmed RCC with a clear-cell component.\n2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria\n3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) \\[PD-1\\]\u002FProgrammed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and\u002For a tyrosine kinase inhibitor\n\nKey Exclusion Criteria:\n\n1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol\n2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol\n3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC\n4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.\n5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol\n6. Any condition that requires ongoing\u002Fcontinuous corticosteroid therapy (\\>10 mg prednisone\u002Fday or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy\n7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol\n8. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living \\[ADLs\\]) or uncontrolled seizures in the year prior to first dose of study therapy\n9. Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency\n\nNOTE: Other protocol defined Inclusion\u002FExclusion Criteria apply",{"count":572,"type":22},345,[240,158],"The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\\[s\\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.\n\nThe study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.\n\nThis study is looking at several other research questions, including:\n\n1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab\n2. How REGN5678 alone or in combination with cemiplimab works in the body\n3. How much REGN5678 and\u002For cemiplimab are present in the blood\n4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor",[576,577],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Clear Cell Renal Cell Carcinoma (ccRCC)",{"date":338,"type":35},{"date":580,"type":35},"2019-08-12",{"date":582,"type":22},"2027-11-15",{"name":41,"class":42},22,{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":592,"enrollmentInfo":593,"targetDuration":4,"studyType":594,"phases":4,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":606},"100447434","an-observational-extension-study-for-adult-patients-treated-in-study-r5459-rt-1944-who-receive-a-kidney-transplant-100447434","NCT05106387","An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant","A Noninterventional Extension Study for Patients Treated in Study R5459-RT-1944 With Vonsetamig (BCMA x CD3 Bispecific Antibody) Who Receive a Kidney Transplant","Inclusion Criteria:\n\n1. Received at least 1 dose of treatment with vonsetamig in study R5459-RT-1944 \\[NCT05092347\\].\n2. Received after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944\n3. Willing and able to comply with clinic visits and study-related procedures\n4. Provide informed consent signed by study patient or legally acceptable representative\n\nExclusion Criteria:\n\n1.There are no exclusion criteria for this study.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply","70 Years",{"count":199,"type":22},"OBSERVATIONAL","The main purpose of this study is to continue to see how vonsetamig works in the body and to monitor the outcomes after kidney transplant for participants previously treated in the R5459-RT-1944 study (NCT05092347).\n\nNo study drug will be given during this study.",[309],[598],"Kidney Transplant","2026-06-19",{"date":364,"type":35},{"date":602,"type":35},"2023-10-19",{"date":604,"type":22},"2028-02-23",{"name":41,"class":42},9,{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":615,"targetDuration":617,"studyType":594,"phases":4,"briefSummary":618,"conditions":619,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":626,"locationsCount":627},"100467174","an-observational-study-to-assess-the-effectiveness-and-safety-of-a-cemiplimab-in-adult-patients-with-advanced-non-small-cell-lung-cancer-nsclc-in-routine-clinical-practice-settings-in-europe-100467174","NCT05363319","An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe","An Observational Study to Assess the Effectiveness and Safety of Cemiplimab Based Regimen in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)","CEMI-LUNG","Key Inclusion Criteria:\n\n1. At least 18 years of age at the time of cemiplimab treatment initiation\n2. Has been diagnosed with histologically or cytologically documented squamous or non-squamous NSCLC\n3. Prescribed a cemiplimab-based regimen as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the Summary of Product Characteristics (SmPC).\n4. Can understand and complete the study-related questionnaires\n5. Must be legally capable of providing written consent for participation in the study and have signed informed consent prior to any study activities\n\nKey Exclusion Criteria:\n\n1. Has received cemiplimab prior to enrollment\n2. Has uncontrolled autoimmune disease\n3. Has a contraindication to cemiplimab as noted in the local SmPC\n4. Is concurrently participating in any other study of an investigational drug or procedure\n5. Has cognitive impairment or other medical condition that, in the opinion of the investigator, would interfere with the ability to complete the study-related questionnaires\n\nNOTE: Other protocol-defined inclusion\u002Fexclusion criteria apply",{"count":616,"type":22},500,"24 Months","This study is focused on patients with non-small cell lung cancer (NSCLC) and have been prescribed a cemiplimab (Libtayo®) based treatment regimen under standard care.\n\nThe goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with NSCLC.",[620],"Non-small Cell Lung Cancer","2026-06-18",{"date":364,"type":35},{"date":624,"type":35},"2022-10-26",{"date":535,"type":22},{"name":41,"class":42},49,{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":23,"phases":637,"briefSummary":638,"conditions":639,"keywords":641,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":651},"100627993","phase-1-a-trial-to-study-if-regn17372-in-combination-with-linvoseltamab-is-tolerable-for-adult-participants-with-relapsedrefractory-multiple-myeloma-100627993","NCT07455851","A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed\u002FRefractory Multiple Myeloma","A FIH Phase 1\u002F2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN17372, an Anti-GPRC5D x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed\u002FRefractory Multiple Myeloma","Key Inclusion Criteria:\n\n1. Participants with RRMM who have exhausted (or are not a candidate for) all therapeutic options that are expected to provide meaningful clinical benefit and have received at least 3 lines of therapy as defined in the protocol\n2. ECOG performance status score ≤1\n3. Participants must have measurable disease for response assessment as described in the protocol\n4. Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol\n2. Participants who have known MM brain lesions or CNS involvement\n3. Participants with a history of PML, a neurocognitive condition or CNS movement disorder, or a history of seizure within 12 months prior to entering screening\n4. Prior treatment with GPRC5D-directed immunotherapies (phase 1 and phase 2) and\u002For prior treatment with a BCMAxCD3 bispecific antibody (phase 2)\n\nNote: Other protocol defined inclusion\u002Fexclusion criteria apply",{"count":636,"type":22},150,[240,158],"This study is researching a drug called REGN17372 used with another drug called linvoseltamab (each individually called \"study drug\" or \"study drugs\" when combined) in participants with relapsed (when a tumor comes back) or refractory (when a tumor does not respond to treatment) multiple myeloma. This study is the first time REGN17372 will be given to humans.\n\nThe aim of the study is to understand if REGN17372 can be given safely with linvoseltamab, and if so, what dosing regimen should be used for this treatment combination, in comparison with linvoseltamab alone.\n\nThe study is looking at:\n\n* What side effects may happen from taking REGN17372 with linvoseltamab\n* How well REGN17372 and linvoseltamab, or linvoseltamab alone, work in treating multiple myeloma\n* What is the best dose of REGN17372 when given with linvoseltamab\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)\n* If and how REGN17372 and linvoseltamab affect the overall quality of life, daily activities, symptoms and treatment side effects based on participant own feedback (Phase 2)",[640],"Relapsed Refractory Multiple Myeloma (RRMM)",[642,643,644],"B-cell maturation antigen (BCMA)","Anti-CD3 monoclonal antibodies (mAbs)","G-protein-coupled receptor class C group 5 member D (GPRC5D)",{"date":621,"type":35},{"date":647,"type":35},"2026-03-26",{"date":649,"type":22},"2033-09-30",{"name":41,"class":42},4,""]