UCB's Global Corporate Website

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
Ongoing
NCT05514873  
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
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
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
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 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
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 Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis (RAISE-XT) Phase 3 RA101495-02.302
Ongoing
NCT04225871 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 [ePub]