{"id":"soliris-eculizumab","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Headache"},{"rate":"10-20%","effect":"Nausea"},{"rate":"10-20%","effect":"Diarrhea"},{"rate":"5-10%","effect":"Muscle spasms"},{"rate":"5-10%","effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Soliris specifically binds to C5 and prevents its cleavage into C5a and C5b, thereby inhibiting the formation of the membrane attack complex and reducing the activation of the complement system. This action reduces the destruction of red blood cells and the activation of the immune system in patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).","oneSentence":"Soliris works by inhibiting the complement system by blocking the action of C5.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:35:26.117Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Paroxysmal nocturnal hemoglobinuria (PNH)"},{"name":"Atypical hemolytic uremic syndrome (aHUS)"}]},"trialDetails":[{"nctId":"NCT05744921","phase":"PHASE3","title":"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","status":"RECRUITING","sponsor":"Regeneron Pharmaceuticals","startDate":"2023-03-07","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":202},{"nctId":"NCT07010302","phase":"PHASE4","title":"Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD","status":"NOT_YET_RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2026-05","conditions":"NMOSD","enrollment":540},{"nctId":"NCT07410039","phase":"PHASE4","title":"Therapy in the Acute Phase of NMOSD: A Multicenter Prospective Real-World Study","status":"RECRUITING","sponsor":"Chinese PLA General Hospital","startDate":"2026-02-01","conditions":"Neuromyelitis Optica Spectrum Disorder Attack","enrollment":200},{"nctId":"NCT07381205","phase":"","title":"Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)","status":"NOT_YET_RECRUITING","sponsor":"Manuel Ricardo Espinoza-Gutarra","startDate":"2026-07-01","conditions":"Transplant Associated Microangiopathy TAM, Transplant Complication","enrollment":85},{"nctId":"NCT05982938","phase":"","title":"Danicopan Early Access Program","status":"AVAILABLE","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"","conditions":"Paroxysmal Nocturnal Hemoglobinuria, PNH, Extravascular Hemolysis","enrollment":""},{"nctId":"NCT05133531","phase":"PHASE3","title":"A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment","status":"RECRUITING","sponsor":"Regeneron Pharmaceuticals","startDate":"2022-08-01","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":190},{"nctId":"NCT07420296","phase":"PHASE4","title":"Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder","status":"RECRUITING","sponsor":"Tianjin Medical University General Hospital","startDate":"2026-01-01","conditions":"Neuromyelitis Optica Spectrum Disorders (NMOSD)","enrollment":198},{"nctId":"NCT04202341","phase":"","title":"Registry of Participants With Generalized Myasthenia Gravis Treated With Alexion C5 Inhibition Therapies (C5ITs)","status":"RECRUITING","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2019-12-02","conditions":"Generalized Myasthenia Gravis","enrollment":500},{"nctId":"NCT03157635","phase":"PHASE1, PHASE2","title":"Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2016-11-14","conditions":"Paroxysmal Hemoglobinuria, Nocturnal","enrollment":59},{"nctId":"NCT07413250","phase":"","title":"Assess Long-Term Safety of Danicopan Add-on Therapy in Participants With Paroxysmal Nocturnal Hemoglobinuria: Analysis of IPIG-Registry Data","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2026-01-14","conditions":"Paroxysmal Nocturnal Hemoglobinuria, PNH","enrollment":50},{"nctId":"NCT07413679","phase":"","title":"Long-term Safety of Danicopan: IPIG Registry-based Cohort Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2025-08-18","conditions":"Paroxysmal Nocturnal Hemoglobinuria, PNH","enrollment":50},{"nctId":"NCT04434092","phase":"PHASE3","title":"A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2020-10-08","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":210},{"nctId":"NCT05966467","phase":"","title":"Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies","status":"RECRUITING","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2024-02-01","conditions":"Neuromyelitis Optica Spectrum Disorder, NMOSD, AQP4+ NMOSD","enrollment":122},{"nctId":"NCT04432584","phase":"PHASE3","title":"A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2020-09-30","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":190},{"nctId":"NCT01374360","phase":"","title":"Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2004-10-29","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":6061},{"nctId":"NCT06764160","phase":"PHASE3","title":"Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2025-01-06","conditions":"Generalized Myasthenia Gravis (gMG), Refractory gMG","enrollment":15},{"nctId":"NCT06449001","phase":"PHASE3","title":"Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis","status":"RECRUITING","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2025-08-11","conditions":"Paroxysmal Nocturnal Hemoglobinuria, PNH, Extravascular Hemolysis","enrollment":6},{"nctId":"NCT06799546","phase":"PHASE3","title":"A Phase III Study to Evaluate the Efficacy and Safety of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy","status":"COMPLETED","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","startDate":"2025-02-13","conditions":"PNH","enrollment":73},{"nctId":"NCT06724809","phase":"PHASE3","title":"Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2025-01-16","conditions":"NMOSD, Neuromyelitis Optica Spectrum Disorders","enrollment":21},{"nctId":"NCT06448715","phase":"","title":"Real-World Treatment Study of Soliris (Eculizumab)","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2024-05-28","conditions":"Observational","enrollment":11},{"nctId":"NCT05876351","phase":"PHASE3","title":"Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2023-07-14","conditions":"Atypical Hemolytic Uremic","enrollment":25},{"nctId":"NCT06513338","phase":"PHASE2","title":"Complement C5 mAb in the Treatment of Anti-GBM Disease","status":"COMPLETED","sponsor":"Peking University First Hospital","startDate":"2024-03-01","conditions":"Autoimmune Diseases","enrollment":16},{"nctId":"NCT06931691","phase":"","title":"A Multi-center, Ambispective Cohort Study to Evaluate the Impact of Iptacopan for Adult Patients With PNH in China","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2025-06-10","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":80},{"nctId":"NCT02113891","phase":"PHASE1, PHASE2","title":"Eculizumab Therapy for Subclinical Antibody-mediated Rejection in Kidney Transplantation","status":"WITHDRAWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2015-02","conditions":"Subclinical Acute Antibody-mediated Rejection in Kidney Transplantation","enrollment":""},{"nctId":"NCT05805202","phase":"NA","title":"Functional Implications of Rare Gene Mutations in aHUS Open the Door to Personalized Therapy","status":"RECRUITING","sponsor":"Mario Negri Institute for Pharmacological Research","startDate":"2023-05-03","conditions":"Atypical Hemolytic Uremic Syndrome","enrollment":112},{"nctId":"NCT07184840","phase":"PHASE2","title":"Eculizumab For the Acute Attack of Neuromyelitis Optica Spectrum Disorder","status":"RECRUITING","sponsor":"Tianjin Medical University General Hospital","startDate":"2025-09-09","conditions":"Neuromyelitis Optica Spectrum Disorder Attack","enrollment":110},{"nctId":"NCT07182409","phase":"","title":"Efficacy and Safety of Monoclonal Antibody in Acute Phase of Neuromyelitis Optica Spectrum Disorder","status":"NOT_YET_RECRUITING","sponsor":"First Affiliated Hospital of Chongqing Medical University","startDate":"2025-10-01","conditions":"NMOSD","enrollment":40},{"nctId":"NCT07177859","phase":"PHASE3","title":"A Phase III Study of NTQ5082 Capsules in the Treatment of Paroxysmal Nocturnal Hemoglobinuria Patients","status":"NOT_YET_RECRUITING","sponsor":"Nanjing Chia-tai Tianqing Pharmaceutical","startDate":"2025-11","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":78},{"nctId":"NCT06593938","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Oral HRS-5965 in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy","status":"COMPLETED","sponsor":"Chengdu Suncadia Medicine Co., Ltd.","startDate":"2024-10-25","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":76},{"nctId":"NCT06673394","phase":"PHASE2","title":"Eculizumab For Acute Attack of Neuromyelitis Optica Spectrum Disorder","status":"WITHDRAWN","sponsor":"Tianjin Medical University General Hospital","startDate":"2025-09-03","conditions":"Neuromyelitis Optica Spectrum Disorder Attack","enrollment":""},{"nctId":"NCT06885957","phase":"","title":"Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD","status":"RECRUITING","sponsor":"Tongji Hospital","startDate":"2025-07-01","conditions":"NMO Spectrum Disorder","enrollment":200},{"nctId":"NCT04752566","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2021-03-08","conditions":"Guillain-Barre Syndrome","enrollment":57},{"nctId":"NCT04888507","phase":"PHASE2","title":"Pozelimab and Cemdisiran Combination Therapy in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy","status":"COMPLETED","sponsor":"Regeneron Pharmaceuticals","startDate":"2021-07-08","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":6},{"nctId":"NCT06411626","phase":"","title":"Home Reported Outcomes in PNH","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2024-06-11","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":128},{"nctId":"NCT04935177","phase":"PHASE3","title":"Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx","status":"COMPLETED","sponsor":"Hansa Biopharma AB","startDate":"2021-10-14","conditions":"Kidney Transplantation in Highly Sensitized Patients","enrollment":64},{"nctId":"NCT05274633","phase":"","title":"Real Life Use of Ravulizumab in Italian Patients With Paroxysmal Nocturnal Hemoglobinuria","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2022-06-17","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":120},{"nctId":"NCT06987864","phase":"PHASE3","title":"An Extension Clinical Study of BCD-148 for the Treatment of Patients With PNH Previously Treated in Clinical Study No. BCD-148-2/NOCTURN","status":"COMPLETED","sponsor":"Biocad","startDate":"2020-04-13","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":24},{"nctId":"NCT06932744","phase":"PHASE3","title":"Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy","status":"RECRUITING","sponsor":"Wuhan Createrna Science and Technology Co., Ltd","startDate":"2024-08-30","conditions":"Paroxysmal Nocturnal Haemoglobinuria (PNH)","enrollment":66},{"nctId":"NCT03427060","phase":"PHASE2","title":"Coversin in PNH in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms","status":"COMPLETED","sponsor":"AKARI Therapeutics","startDate":"2018-05-14","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":1},{"nctId":"NCT04469465","phase":"PHASE3","title":"Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2020-12-16","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":86},{"nctId":"NCT05886244","phase":"PHASE3","title":"Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2023-07-05","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":25},{"nctId":"NCT04702568","phase":"PHASE2","title":"A Long-Term Safety Study of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)","status":"TERMINATED","sponsor":"BioCryst Pharmaceuticals","startDate":"2020-12-18","conditions":"Paroxysmal Nocturnal Hemoglobinuria, PNH","enrollment":19},{"nctId":"NCT05131204","phase":"PHASE3","title":"Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria","status":"TERMINATED","sponsor":"Regeneron Pharmaceuticals","startDate":"2022-10-06","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":3},{"nctId":"NCT05731050","phase":"PHASE2","title":"Study of NM8074 in Soliris-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","status":"NOT_YET_RECRUITING","sponsor":"NovelMed Therapeutics","startDate":"2026-06","conditions":"PNH - Paroxysmal Nocturnal Hemoglobinuria","enrollment":6},{"nctId":"NCT04859608","phase":"PHASE3","title":"Personalized Spacing of Eculizumab Infusions Based on Therapeutic Pharmacological Monitoring (EspacECU)","status":"COMPLETED","sponsor":"University Hospital, Tours","startDate":"2021-10-20","conditions":"Hemolytic-Uremic Syndrome, Atypical","enrollment":40},{"nctId":"NCT06888622","phase":"","title":"BLAZE-Limiting Approach in NMOSD","status":"COMPLETED","sponsor":"Huashan Hospital","startDate":"2023-10-01","conditions":"Neuromyelitis Optica Spectrum Disorders (NMOSD)","enrollment":9},{"nctId":"NCT03056040","phase":"PHASE3","title":"ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2017-05-17","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":202},{"nctId":"NCT05646563","phase":"PHASE2","title":"Study of NM8074 in Adult PNH Patients with Inadequate Response to Soliris","status":"NOT_YET_RECRUITING","sponsor":"NovelMed Therapeutics","startDate":"2026-01","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":12},{"nctId":"NCT05116774","phase":"PHASE2","title":"BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants With Inadequate Response to C5 Inhibitor Therapy","status":"TERMINATED","sponsor":"BioCryst Pharmaceuticals","startDate":"2021-12-06","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":12},{"nctId":"NCT05337683","phase":"","title":"A Retrospective Non-Interventional Study to Evaluate the Impact of Eculizumab in Korean PNH Patients","status":"COMPLETED","sponsor":"Handok Inc.","startDate":"2020-12-11","conditions":"PNH","enrollment":80},{"nctId":"NCT05405777","phase":"","title":"A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in aHUS Patients in South Korea","status":"COMPLETED","sponsor":"Handok Inc.","startDate":"2022-10-04","conditions":"aHUS","enrollment":97},{"nctId":"NCT03759366","phase":"PHASE3","title":"A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2018-12-28","conditions":"Myasthenia Gravis, Myasthenia Gravis, Juvenile Form, Myasthenia Gravis, Generalized","enrollment":12},{"nctId":"NCT04170023","phase":"PHASE2","title":"Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy","status":"TERMINATED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2019-12-16","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":29},{"nctId":"NCT04558918","phase":"PHASE3","title":"Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2021-01-25","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":97},{"nctId":"NCT04155424","phase":"PHASE2, PHASE3","title":"A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder","status":"TERMINATED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2020-01-14","conditions":"Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder","enrollment":5},{"nctId":"NCT03748823","phase":"PHASE3","title":"Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2019-02-19","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":139},{"nctId":"NCT04320602","phase":"PHASE4","title":"Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2021-04-14","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":18},{"nctId":"NCT02714374","phase":"PHASE1","title":"GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers","status":"TERMINATED","sponsor":"Andrew Lowy","startDate":"2016-03-25","conditions":"Solid Organ Cancers","enrollment":5},{"nctId":"NCT06453135","phase":"PHASE1, PHASE2","title":"Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation","status":"NOT_YET_RECRUITING","sponsor":"Tao Lin","startDate":"2024-07","conditions":"Kidney Transplantation","enrollment":30},{"nctId":"NCT03439839","phase":"PHASE2","title":"Study of Safety, Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics of LNP023 in in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2018-04-09","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH) With Signs of Active Hemolysis","enrollment":16},{"nctId":"NCT02946463","phase":"PHASE3","title":"ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2016-12-12","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":272},{"nctId":"NCT04351503","phase":"","title":"A Systems Approach to Predict the Outcome of SARS-CoV-2 in the Population of a City; COVID-19","status":"COMPLETED","sponsor":"University Hospital, Basel, Switzerland","startDate":"2020-04-09","conditions":"SARS Coronavirus (SARS-CoV-2) Infection","enrollment":126586},{"nctId":"NCT04058158","phase":"PHASE3","title":"A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria","status":"COMPLETED","sponsor":"Samsung Bioepis Co., Ltd.","startDate":"2019-08-07","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":50},{"nctId":"NCT05726916","phase":"PHASE3","title":"Eculizumab in Hypertensive Emergency-associated Hemolytic Uremic Syndrome","status":"RECRUITING","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2023-11-09","conditions":"Hypertensive Emergency-associated Hemolytic Uremic Syndrome","enrollment":66},{"nctId":"NCT03472885","phase":"PHASE2","title":"Study of Danicopan in Participants With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Response to Eculizumab","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2018-05-08","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":12},{"nctId":"NCT04725812","phase":"PHASE2","title":"Complement Regulation to Undo Systemic Harm in Preeclampsia","status":"TERMINATED","sponsor":"Cedars-Sinai Medical Center","startDate":"2021-09-13","conditions":"Preeclampsia, Severe Preeclampsia, Eculizumab","enrollment":2},{"nctId":"NCT05863442","phase":"PHASE1","title":"Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants","status":"UNKNOWN","sponsor":"Turgut Ardika PTY LTD","startDate":"2023-04-10","conditions":"Healthy","enrollment":120},{"nctId":"NCT04103489","phase":"PHASE1","title":"The Use of Eculizumab in HELLP Syndrome","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2021-02-23","conditions":"HELLP Syndrome (HELLP), Third Trimester, Complement Abnormality, Morbidity;Newborn","enrollment":3},{"nctId":"NCT06098378","phase":"","title":"Study of Patients With Thrombotic Microangiopathy Associated With Mitomycin C, Treated or Not With Eculizumab","status":"UNKNOWN","sponsor":"University Hospital, Strasbourg, France","startDate":"2023-06-07","conditions":"Thrombotic Microangiopathies","enrollment":30},{"nctId":"NCT03518203","phase":"PHASE2","title":"Eculizumab to Treat Thrombotic Microangiopathy/Atypical Hemolytic Uremic Syndrome -Associated Multiple Organ Dysfunction Syndrome in Hematopoietic Stem Cell Transplant Recipients","status":"COMPLETED","sponsor":"Children's Hospital Medical Center, Cincinnati","startDate":"2018-08-03","conditions":"Thrombotic Microangiopathies, Atypical Hemolytic Uremic Syndrome, Multiple Organ Dysfunction Syndrome","enrollment":23},{"nctId":"NCT04671810","phase":"","title":"Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria®","status":"COMPLETED","sponsor":"AO GENERIUM","startDate":"2019-06-13","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":44},{"nctId":"NCT01770951","phase":"","title":"A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2009-08-31","conditions":"Atypical Hemolytic Uremic Syndrome (aHUS)","enrollment":30},{"nctId":"NCT02591862","phase":"PHASE2","title":"Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)","status":"COMPLETED","sponsor":"AKARI Therapeutics","startDate":"2016-02","conditions":"Paroxysmal Nocturnal Haemoglobinuria (PNH)","enrollment":1},{"nctId":"NCT03818607","phase":"PHASE3","title":"A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH","status":"COMPLETED","sponsor":"Amgen","startDate":"2019-01-22","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":42},{"nctId":"NCT05842486","phase":"","title":"Hematological Response in Patients With Paroxysmal Nocturnal Hemoglobinuria Treated With Anti-C5 Antibody: an External Control Arm Study for Iptacopan Use in Anti-C5 naïve Patients","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2023-01-18","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":92},{"nctId":"NCT03406507","phase":"PHASE3","title":"A Study of Ravulizumab (ALXN1210) in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2018-02-22","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":13},{"nctId":"NCT05702996","phase":"PHASE3","title":"Multicenter, Uncontrolled Pilot Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies","status":"UNKNOWN","sponsor":"University Hospital, Rouen","startDate":"2023-03","conditions":"Thrombotic Microangiopathies","enrollment":10},{"nctId":"NCT04079257","phase":"","title":"The Pharmacokinetics and Pharmacodynamics of Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2021-02-23","conditions":"Paroxysmal Nocturnal Hemoglobinuria, Eculizumab, PK-PD","enrollment":27},{"nctId":"NCT02003144","phase":"PHASE3","title":"An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2015-01-12","conditions":"Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder","enrollment":119},{"nctId":"NCT04749810","phase":"","title":"Observational Study of Elizaria® in aHUS Patients","status":"COMPLETED","sponsor":"AO GENERIUM","startDate":"2019-12-19","conditions":"Atypical Hemolytic Uremic Syndrome, aHUS","enrollment":50},{"nctId":"NCT03078582","phase":"PHASE2","title":"Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients","status":"COMPLETED","sponsor":"Ra Pharmaceuticals","startDate":"2017-03-08","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":26},{"nctId":"NCT03030183","phase":"PHASE2","title":"Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab","status":"COMPLETED","sponsor":"Ra Pharmaceuticals","startDate":"2017-04-17","conditions":"Paroxysmal Nocturnal Hemoglobinuria (PNH)","enrollment":3},{"nctId":"NCT03500549","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)","status":"COMPLETED","sponsor":"Apellis Pharmaceuticals, Inc.","startDate":"2018-06-14","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":80},{"nctId":"NCT04802083","phase":"","title":"COVID-19 Soliris Expanded Access Protocol","status":"NO_LONGER_AVAILABLE","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"","conditions":"Covid19","enrollment":""},{"nctId":"NCT04463056","phase":"PHASE3","title":"Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH","status":"COMPLETED","sponsor":"AO GENERIUM","startDate":"2017-11-29","conditions":"Paroxysmal Nocturnal Hemoglobinuria, Marchiafava-Micheli Syndrome, Paroxysmal Hemoglobinuria","enrollment":32},{"nctId":"NCT02013037","phase":"PHASE3","title":"The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation","status":"COMPLETED","sponsor":"Cedars-Sinai Medical Center","startDate":"2012-11","conditions":"Antibody-mediated Rejection, Hyperacute Rejection of Cardiac Transplant, Left Ventricular Dysfunction","enrollment":36},{"nctId":"NCT03468140","phase":"EARLY_PHASE1","title":"Pilot Trial of Eculizumab Therapy to Reduce Preservation Injury in Human Macrosteatotic Liver Transplantation","status":"WITHDRAWN","sponsor":"Yale University","startDate":"2021-10-01","conditions":"End Stage Liver Disease","enrollment":""},{"nctId":"NCT03999840","phase":"PHASE2","title":"Eculizumab to Cemdisiran Switch in aHUS","status":"WITHDRAWN","sponsor":"Mario Negri Institute for Pharmacological Research","startDate":"2021-01","conditions":"Atypical Hemolytic Uremic Syndrome","enrollment":""},{"nctId":"NCT04355494","phase":"","title":"SOLIRIS® (Eculizumab) Treatment of Participants With COVID-19","status":"NO_LONGER_AVAILABLE","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"","conditions":"COVID-19, Pneumonia, Viral, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)","enrollment":""},{"nctId":"NCT04060264","phase":"PHASE3","title":"Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria","status":"COMPLETED","sponsor":"Biocad","startDate":"2019-04-04","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":28},{"nctId":"NCT04679103","phase":"PHASE3","title":"A Safety and Immunogenicity Study in Long-term Treatment of Eculizumab (JSC \"GENERIUM\", Russian Federation)","status":"COMPLETED","sponsor":"AO GENERIUM","startDate":"2018-05-03","conditions":"Paroxysmal Nocturnal Hemoglobinuria","enrollment":50},{"nctId":"NCT01029587","phase":"PHASE2","title":"Eculizumab to Enable Renal Transplantation in Patients With History of Catastrophic Antiphospholipid Antibody Syndrome","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2009-11","conditions":"Antiphospholipid Antibody Syndrome, End Stage Renal Disease","enrollment":1},{"nctId":"NCT03574506","phase":"","title":"Eculizumab Use in the Postpartum Period for the Treatment of Pregnancy Associated aHUS: A Case Series","status":"UNKNOWN","sponsor":"Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia","startDate":"2018-04-15","conditions":"Atypical Hemolytic Uremic Syndrome, Pregnancy","enrollment":50},{"nctId":"NCT04027803","phase":"PHASE1","title":"Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®","status":"COMPLETED","sponsor":"Biocad","startDate":"2018-09-21","conditions":"Healthy Subjects","enrollment":78},{"nctId":"NCT04346797","phase":"PHASE2","title":"CORIMUNO19-ECU: Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection, Nested in the CORIMUNO-19 Cohort","status":"UNKNOWN","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2020-04-16","conditions":"SARS-CoV-2, COVID19","enrollment":120},{"nctId":"NCT04288713","phase":"","title":"Eculizumab (Soliris) in Covid-19 Infected Patients","status":"AVAILABLE","sponsor":"Hudson Medical","startDate":"","conditions":"Coronavirus","enrollment":""},{"nctId":"NCT02301624","phase":"PHASE3","title":"Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2014-11-12","conditions":"Refractory Generalized Myasthenia Gravis","enrollment":117},{"nctId":"NCT03722329","phase":"PHASE1","title":"Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects","status":"COMPLETED","sponsor":"Samsung Bioepis Co., Ltd.","startDate":"2018-11-13","conditions":"Healthy","enrollment":240},{"nctId":"NCT02614898","phase":"","title":"Evaluation of Potential Predictors of Disease Progression in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Including Genetics, Biomarkers, and Treatment","status":"TERMINATED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2015-11-04","conditions":"Atypical Hemolytic Uremic Syndrome","enrollment":67},{"nctId":"NCT02574403","phase":"PHASE4","title":"Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With aHUS","status":"COMPLETED","sponsor":"Nantes University Hospital","startDate":"2015-11","conditions":"Atypical Hemolytic Uremic Syndrome","enrollment":58}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"FATIGUE"},{"count":1,"reaction":"HAEMOGLOBIN DECREASED"}],"_approvalHistory":[],"publicationCount":3167,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Soliris (eculizumab)","genericName":"Soliris (eculizumab)","companyName":"Samsung Bioepis Co., Ltd.","companyId":"samsung-bioepis-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Soliris works by inhibiting the complement system by blocking the action of C5. Used for Paroxysmal nocturnal hemoglobinuria (PNH), Atypical hemolytic uremic syndrome (aHUS).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}