Zilucoplan (Zilbrysq®)
| Disease area studied | Abbreviated title | Phase | Study ID | Registry database | Study results | Plain language summary | Publication (if available) |
|---|---|---|---|---|---|---|---|
| Generalized Myasthenia Gravis | An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors | Phase 3 |
MG0017
Completed |
NCT05514873 | Freimer M., et al. Neurology 2024; 102(17 Suppl.1) 76th Annual Meeting of American Academy of Neurology (AAN), April 13-18, 2024; Denver, USA | ||
| Paroxysmal Nocturnal Hemoglobinuria | Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients | Phase 2 |
RA101495-01.201
Completed |
NCT03078582 2016-003522-16 |
LINK LINK |
Kulasekararaj A.G.et al. Haematologica 2024, 109(3):929-935 | |
| Paroxysmal Nocturnal Hemoglobinuria | Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study | Phase 2 |
RA101495-01.202
Terminated |
NCT03225287 2016-003523-34 |
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| Paroxysmal Nocturnal Hemoglobinuria | Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab | Phase 2 |
RA101495-01.203
Completed |
NCT03030183 |
LINK
|
Kulasekararaj A.G.et al. Haematologica 2024, 109(3):929-935 | |
| Generalized Myasthenia Gravis | Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis | Phase 2 |
RA101495-02.201
Completed |
NCT03315130 |
LINK
|
Howard J.F., JAMA neurology 2020; 77(5):582–92 | |
| Immune-Mediated Necrotizing Myopathy | Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy | Phase 2 |
RA101495-02.202
Terminated |
NCT04025632 2019-001497-29 |
LINK LINK |
Mammen A.L. et al. Lancet Rheumatology 2023; 5(2):e67-e76 | |
| Generalized Myasthenia Gravis | Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis (RAISE) | Phase 3 |
RA101495-02.301
Completed |
NCT04115293 2019-001564-30 |
Howard J.F. Lancet Neurol 2023; 22(5):395–406 | ||
| Generalized Myasthenia Gravis | Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis (RAISE-XT) | Phase 3 |
RA101495-02.302
Ongoing |
NCT04225871 2024-512399-37-00 |
Freimer M. et al. Neurology 2023; 100(17 suppl.2), 75th Annual Meeting of American Academy of Neurology (AAN), April 22-27, 2023; Boston, USA Weiss M.D. et al. Journal of neurology 2024, 271(5): 2758-2767 | ||
| Generalized Myasthenia Gravis | A Study to Evaluate the Safe and Effective Use of a Zilucoplan Auto-injector by Study Participants With Generalized Myasthenia Gravis | Phase 3 |
DV0013
Ongoing |
NCT06471361 2023-508287-30-00 |