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

Date Added
March 8th, 2022
PRO Number
Pro00112238
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
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 drug.

Participants will first 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 through an infusion (IV). Participants with come for an office visit every 2 weeks to obtain the infusion, complete questionnaires, perform safety assessments and lab tests.

At the end of the Double-Blind treatment period, your study doctor will determine if you are eligible to enroll in the Open-Label Extension (OLE) period in which you would be able to receive nipocalimab infusions for approximately 2-5 years. There also may be a chance you did not participate in the Double-Blind Treatment Period of this study but can still enroll in the Open-Label Extension. Participants will complete the same activities in the OLE has the Double-Blind Placebo-Controlled Treatment Period.

The total amount of time the subject would be on the study is about 6 months for the Double-Blind Placebo-Controlled Treatment Period with an additional 2-5 years for the Open-Label Extension (OLE) period.

Institution
MUSC
Recruitment Contact
Aparna Choudhury
843-792-2845
choudhur@musc.edu

PROMISE-MG: Prospective Multicenter Observational Cohort Study of Comparative Effectiveness of Disease-Modifying Treatments for Myasthenia Gravis

Date Added
September 24th, 2018
PRO Number
Pro00077927
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Muscle, Nervous System
Summary

This is an observational study to develop a research registry to collect information from subjects with Myasthenia Gravis (MG) to evaluate the effects of the treatments they receive and to understand how their medical condition and treatment affects their daily life.

Institution
MUSC
Recruitment Contact
Katrina Madden
843-792-9186
maddenka@musc.edu



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