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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504152-97-00

Acronym

MOM-M281-011

Enrollment

125

Registered

2023-09-11

Start date

2021-11-26

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Myasthenia Gravis

Brief summary

Average change from baseline (screening and Day 1) in MG-ADL total score over Weeks 22, 23 and 24.

Interventions

DRUGJNJ-80202135

DRUGSaline (placebo) is being used in accordance with the terms of its marketing authorization.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Average change from baseline (screening and Day 1) in MG-ADL total score over Weeks 22, 23 and 24.	—

Countries

Belgium, Czechia, Denmark, France, Germany, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026