clinical trial · NCT04951622
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Janssen Research & Development, LLC·phase3·recruiting·n = 199
Myasthenia GravisNipocalimabPlaceboNipocalimab SC-LIV
brief 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.
started
Jul 15, 2021
primary completion
Nov 17, 2023
completion
Mar 29, 2029
last updated
Jul 27, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol