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Clinical Trials in the EU / 2025-521130-28-00
Ongoing Phase III

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

2025-521130-28-00 · tracked via the Priya Life Science EU tracker
Sponsor
Janssen Cilag International
Sponsor type
Pharmaceutical company
Therapeutic area
Immune System Diseases
Decision date
10/12/2025
Enrollment target
29
Sites
Austria, Germany, Spain, Italy

Condition studied

generalized myasthenia gravis

Investigational medicinal product(s)

EFGARTIGIMOD ALFAJNJ-80202135

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Averaged mean change from baseline in Myasthenia GravisActivities of Daily Living (MG-ADL) total score over Weeks 8 to 12 between Arms 1 and 2. Averaged mean percent change from baseline in total IgG over Weeks 8 to 12 between Arms 1 and 2.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-521130-28-00 on CTIS ↗ ← All trials in the EU