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
Janssen Research & Development, LLC
199 participants
Jul 15, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Nipocalimab will be administered as an IV infusion.
Matching placebo will be administered as an IV infusion.
Nipocalimab will be administered subcutaneously.
Locations(112)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04951622