NCT04951622

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 199 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Nipocalimab	Nipocalimab will be administered as an IV infusion.
DRUG	Placebo	Matching placebo will be administered as an IV infusion.
DRUG	Nipocalimab SC-LIV	Nipocalimab will be administered subcutaneously.

Timeline

• Start date: 2021-07-15
• Primary completion: 2023-11-17
• Completion: 2029-03-30
• First posted: 2021-07-07
• Last updated: 2026-03-03
• Results posted: 2025-07-23

Locations

112 sites across 17 countries: United States, Australia, Belgium, Canada, China, Czechia, Denmark, France, Germany, Italy, Japan, Mexico, Poland, South Korea, Spain, Sweden, Taiwan

Regulatory

• FDA-regulated drug study