Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab
Janssen Research & Development, LLC
Summary
The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).
Eligibility
- Age range
- 18–74 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: For all arms: * Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening * Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the Myasthenia gravis foundation of America (MGFA) clinical classification class II a/b, III a/b, or IV a/b at screening and positive for acetylcholine receptor (AChR) antibodies * Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater…
Interventions
- DrugNipocalimab
Nipocalimab will be administered intravenously.
- DrugEfgartigimod
Efgartigimod will be administered intravenously.
Locations (12)
- The Neurology GroupPomona, California
- Advanced Neurology of ColoradoFort Collins, Colorado
- University of ConnecticutFarmington, Connecticut
- SFM Clinical Research LLCBoca Raton, Florida
- HSHS St. Elizabeth's HospitalO'Fallon, Illinois
- Henry Ford HospitalDetroit, Michigan