NCT07039916

Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 231 (estimated)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	IMVT-1402	• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)
DRUG	IMVT-1402	* Dose 2 SC QW for 12 weeks (Period 1) * Dose 2 SC QW for 14 weeks (Period 2) * Dose 2 SC QW for 52 weeks (Period 3)
DRUG	Placebo	• Placebo SC QW for 12 weeks (Period 1)
DRUG	IMVT-1402	* Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3)

Timeline

• Start date: 2025-05-27
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-06-26
• Last updated: 2026-03-06

Locations

75 sites across 13 countries: United States, Czechia, Denmark, Georgia, Germany, Greece, Hungary, Italy, Poland, Romania, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study