A Study 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
About This Trial
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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
Nipocalimab
Nipocalimab will be administered as an IV infusion.
Placebo
Matching placebo will be administered as an IV infusion.
Nipocalimab SC-LIV
Nipocalimab will be administered subcutaneously.