A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis

2024-515979-35-00 · tracked via the Priya Life Science EU tracker

Sponsor

Immunovant Sciences GmbH

Sponsor type

Pharmaceutical company

Therapeutic area

Nervous System Diseases

Decision date

20/10/2025

Enrollment target

159

Sites

Czechia, Greece, Spain, Italy, Denmark, Germany, Romania, Poland, Hungary

Condition studied

Generalized Myasthenia Gravis

Investigational medicinal product(s)

IMVT-1402Placebo is identical to IMP but with no active substance

Eligibility

Age group

18-64 years, 65+ years

Sex

Female, Male

Primary endpoint

Change from baseline in MG-ADL Score for Antibody-positive Participants

Endpoint detail

Change from baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants, Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1, Percentage of Antibody-Positive Participants with ≥50% Improvement in MG-ADL Score

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 2024-515979-35-00 on CTIS ↗ ← All trials in the EU