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Clinical trial

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

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Last updated:15th Aug 2023
Identifier: NCT04951622
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis ID: NCT04951622

Sponsor: Janssen Research & Development, LLC
Information provided by: Janssen Research & Development, LLC (Responsible Party)
Last Update Posted: 2023-08-16

Brief 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).

Detailed Description:
Myasthenia gravis (MG) is a rare, heterogeneous, neuromuscular disease characterized by fluctuating, fatigable muscle weakness. MG is caused by pathogenic autoantibodies that impair cholinergic transmission in the postsynaptic membrane at the neuromuscular junction and impair or prevent muscle contraction. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human, aglycosylated immunoglobulin (Ig)G1 monoclonal antibody (mAb) designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal Fc receptor (FcRn). This study will consist of a screening phase (up to 4 weeks), treatment phase (a 24-week double-blind placebo-controlled phase, and an open-label extension [OLE] phase [up to 2 years]) and a follow-up safety visit (up to 8 weeks after last infusion of study intervention). Efficacy evaluations will include assessments such as Myasthenia Gravis - Activities of Daily Living (MG-ADL) score. Safety evaluations (such as adverse events, physical examination, vital signs, electrocardiogram [ECG], and clinical laboratory tests) will be performed. The overall duration of study will be up to 4 years and 8 months.

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

Drug: Nipocalimab
Drug: Placebo

Category Value
Study Start (Estimated) 2021-07-15
Primary Completion (Estimated) 2023-11-01
Study Completion 2026-04-17
Enrollment (Estimated) 198
Study Type Interventional
Phase Phase 3
Other Study ID Numbers CR109046
2020-005732-29 (EudraCT Number)
MOM-M281-011 (Other Identifier) (OTHER: Janssen Research & Development, LLC)

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