Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

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

Outcome

Met primary endpoint

paper Ravulizumab significantly increased the magnitude of mean changes from baseline to week 26 versus placebo in MG-ADL (−3.1 vs. −1.4; P<0.001) PMID 38319212 ↗

registry analysis (superiority test); Ravulizumab vs Placebo; p =0.0009; LS Mean Difference -1.6 (95% CI -2.6 to -0.7) NCT03920293 ↗

release “positive results from the CHAMPION-MG Phase III trial, in which Ultomiris was superior to placebo in the primary endpoint” astrazeneca.com ↗

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

Indications