9 completed, 3 terminated, 1 active not recruiting. 13 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 9, Terminated 3, Active not recruiting 1 |
| Phase 2 | 2 | Completed 1, Terminated 1 |
Follow Soliris: new trials by email Literature Review of Soliris trials Research Report on Soliris
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Cemdisiran, Eculizumab, Pozelimab - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Terminated | Regeneron Pharmaceuticals | 3 | 2022-10-06 | 2025-04-08 |
| 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 Ravulizumab, Pozelimab, Cemdisiran - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Active not recruiting | Regeneron Pharmaceuticals | 202 | 2022-08-01 | 2026-04-30 |
| Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx Imlifidase, PLEX, IVIg - Kidney Transplantation in Highly Sensitized Patients | Phase 3 | Completed | Hansa Biopharma AB | 64 | 2021-10-14 | 2026-04-30 |
| A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome Eculizumab, Placebo - Guillain-Barre Syndrome | Phase 3 | Completed | Alexion Pharmaceuticals, Inc. | 57 | 2021-03-08 | 2025-09-08 |
| A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum Disorder Eculizumab - Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder | Phase 2 / Phase 3 | Terminated | Alexion Pharmaceuticals, Inc. | 5 | 2020-01-14 | 2024-09-25 |
| Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria BCD-148, Soliris - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Completed | Biocad | 28 | 2019-04-04 | 2021-02-12 |
| A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH ABP 959, Eculizumab - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Completed | Amgen | 42 | 2019-01-22 | 2023-05-23 |
| Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Pegcetacoplan, Soliris - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Completed | Apellis Pharmaceuticals, Inc. | 80 | 2018-06-14 | 2022-03-25 |
| An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients eculizumab - Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder | Phase 3 | Completed | Alexion Pharmaceuticals, Inc. | 119 | 2015-01-12 | 2022-08-23 |
| Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study) Eculizumab, Placebo - Delayed Graft Function | Phase 2 / Phase 3 | Completed | Alexion Pharmaceuticals, Inc. | 288 | 2014-08-21 | 2018-12-17 |
| A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study) Eculizumab, Placebo - Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder | Phase 3 | Terminated | Alexion Pharmaceuticals, Inc. | 143 | 2014-04-11 | 2019-06-26 |
| The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation Eculizumab - Antibody-mediated Rejection, Hyperacute Rejection of Cardiac Transplant | Phase 3 | Completed | Cedars-Sinai Medical Center | 36 | 2012-11-01 | 2021-05-03 |
| Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) eculizumab - Paroxysmal Hemoglobinuria, Nocturnal | Phase 3 | Completed | Alexion Pharmaceuticals, Inc. | 187 | 2005-05-01 | 2018-03-13 |
Hemoglobinuria, Paroxysmal (6) · Demyelinating Diseases (3) · Myelitis, Transverse (3) · Neuromyelitis Optica (3) · Optic Neuritis (3) · Recurrence (3) · Complement Component 3 Deficiency, Autosomal Recessive (1) · Delayed Graft Function (1) · Guillain-Barre Syndrome (1) · Hemolysis (1) · Ventricular Dysfunction, Left (1)
Alexion Pharmaceuticals, Inc. (6) · Regeneron Pharmaceuticals (2) · Amgen (1) · Apellis Pharmaceuticals, Inc. (1) · Biocad (1) · Cedars-Sinai Medical Center (1) · Hansa Biopharma AB (1)
United States (11) · Spain (8) · Italy (7) · Canada (6) · Germany (6) · Japan (6) · United Kingdom (6) · Australia (5) · South Korea (5) · Czechia (4) · France (4) · Russia (4) · Turkey (Türkiye) (4) · Malaysia (3) · Taiwan (3)
Jignesh Patel, M.D., Ph.D. (1) · Roman Ivanov, PhD (1)
PMID 33676197, PMID 34498507, PMID 17702897, PMID 31050279, PMID 33251691, PMID 33310418, PMID 33730455, PMID 34445916, PMID 34803867, PMID 35796199, PMID 35869984, PMID 36055332, PMID 37182818, PMID 37707673, PMID 38593241, PMID 38727860, PMID 38987228, PMID 39079163, PMID 39171864, PMID 40285403, PMID 40720060, PMID 42763038
2019 (1), 2023 (1)