Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07217587

Comparative Efficacy of Nipocalimab and Efgartigimod in Participants With Generalized Myasthenia Gravis

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

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
115 (estimated)
Sponsor
Janssen Research & Development, LLC · Industry
Sex
All
Age
18 Years – 74 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGNipocalimabNipocalimab will be administered intravenously.
DRUGEfgartigimodEfgartigimod will be administered intravenously.

Timeline

Start date
2026-01-05
Primary completion
2027-09-28
Completion
2028-12-11
First posted
2025-10-16
Last updated
2026-04-13

Locations

8 sites across 2 countries: United States, Israel

Regulatory

Source: ClinicalTrials.gov record NCT07217587. Inclusion in this directory is not an endorsement.