A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis

Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281 administered to participants with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing standard of care therapy.

Timeline

Start

2019-04-10

Primary completion

2020-06-25

Completion

2020-06-25

Publications

• Antozzi C, Guptill J, Bril V, Gamez J, Meuth SG, Nowak RJ, Quan D, Sevilla T, Jouvin MH, Jin J, Karcher K, Ramchandren S, Sun H, Ling L, Zhu Y, Arroyo S; Vivacity-MG Phase 2 Study Group. Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis: Results From the Randomized Phase 2 Vivacity-MG Study. Neurology. 2024 Jan 23;102(2):e207937. doi: 10.1212/WNL.0000000000207937. Epub 2023 Dec 21.

Drugs

Indications