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
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b, III a/b, or IVa/b at screening * Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 6 at screening and baseline * Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol * A woman of childbearing potential must have a negative highly sen…
Interventions
- DrugNipocalimab
Nipocalimab will be administered as an IV infusion.
- DrugPlacebo
Matching placebo will be administered as an IV infusion.
- DrugNipocalimab SC-LIV
Nipocalimab will be administered subcutaneously.
Locations (112)
- Neuromuscular Research Center and ClinicParadise Valley, Arizona
- HonorHealth NeurologyScottsdale, Arizona
- University of Southern CaliforniaLos Angeles, California
- Stanford UniversityPalo Alto, California
- Care Access ResearchPasadena, California
- University of Colorado Anschutz Medical CampusAurora, Colorado