Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic [PD]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.
Inclusion Criteria:
Exclusion Criteria:
Participate-In-This-Study1@its.jnj.com844-434-4210
Boca Raton, Florida 33487, United States
Guangzhou, 510405, China
Xi'an, 710038, China
Provence-Alpes-Côte d'Azur, 06000, France
Provence-Alpes-Côte d'Azur, 06000, France
Naples, 80138, Italy
Itabashi Ku, 173 8606, Japan
Kawasaki Shi, 216 8511, Japan
Kita Gun, 761 0793, Japan
Nishinomiya-Shi, 663-8501, Japan
Shiwa-gun, 028-3695, Japan