drugset / Trial / NCT03920293
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).
Timeline
- Start
- 2019-03-12
- Primary completion
- 2021-05-11
- Completion
- 2023-05-25
Publications
- Vu T, Meisel A, Mantegazza R, Annane D, Katsuno M, Aguzzi R, Enayetallah A, Beasley KN, Rampal N, Howard JF. Terminal Complement Inhibitor Ravulizumab in Generalized Myasthenia Gravis. NEJM Evid. 2022 May;1(5):EVIDoa2100066. doi: 10.1056/EVIDoa2100066. Epub 2022 Apr 26.
- Meisel A, Annane D, Vu T, Mantegazza R, Katsuno M, Aguzzi R, Frick G, Gault L, Howard JF Jr; CHAMPION MG Study Group. Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase 3 CHAMPION MG open-label extension. J Neurol. 2023 Aug;270(8):3862-3875. doi: 10.1007/s00415-023-11699-x. Epub 2023 Apr 27.
- Vu T, Ortiz S, Katsuno M, Annane D, Mantegazza R, Beasley KN, Aguzzi R, Howard JF Jr. Ravulizumab pharmacokinetics and pharmacodynamics in patients with generalized myasthenia gravis. J Neurol. 2023 Jun;270(6):3129-3137. doi: 10.1007/s00415-023-11617-1. Epub 2023 Mar 9.
- Vanoli F, Mantegazza R. Ravulizumab for the treatment of myasthenia gravis. Expert Opin Biol Ther. 2023 Mar;23(3):235-241. doi: 10.1080/14712598.2023.2185131. Epub 2023 Mar 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ravulizumab | Monoclonal antibody | 3000 mg | Intravenous |
| Subject | Ravulizumab | Monoclonal antibody | 3300 mg | Intravenous |
| Subject | Ravulizumab | Monoclonal antibody | 3600 mg | Intravenous |