Efficacy and Safety Study of Nipocalimab Intravenous Infusions for Generalized Myasthenia Gravis
Research type
Research Study
Full 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
IRAS ID
1003839
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2020-005732-29
Research summary
The purpose of this study is to see if nipocalimab is safe and useful for treating Adults with Generalized Myasthenia Gravis. Myasthenia gravis (MG) is a rare disease that affects the muscles and brain; causes tiredness and weakness in the eye muscles, arms, legs, and neck, and may cause difficulty with breathing. You must be diagnosed with myasthenia gravis to be in this study. Another purpose of this study is to find out how long nipocalimab stays in and acts on your body. This is measured by blood tests. Another purpose is to find out if nipocalimab can cause side effects, which are unexpected or unwanted reactions from taking a medication.
Participates will be enrolled into the Double-Blind Placebo-Controlled Treatment Period which will last for about 24 weeks. Participants in this period of the study will receive either nipocalimab or a placebo.
At the end of the Double-Blind treatment period, the study doctor will determine if participants are eligible to enroll in the Open-Label Extension (OLE) period in which participants would be able to receive nipocalimab infusions for approximately 2-5 years. There also may be a chance that participants may not participate in the Double-Blind Treatment Period of this study but can still enroll in the Open-Label Extension.
About 180 participants will take part in this study worldwide. Participants will be in the study for approximately 2 ½ to 5 years, inclusive of the long-term extension period.REC name
North West - Haydock Research Ethics Committee
REC reference
21/NW/0216
Date of REC Opinion
19 Aug 2021
REC opinion
Further Information Favourable Opinion