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Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis
RecruitingPhase 3
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
Who can join
Ages 18 to 80 · All sexes
Full eligibility criteria
Inclusion Criteria: * Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures. * Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at the Screening Visit * Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1) Additional inclusion criteria are defined in the protocol. Exclusion Criteria: * Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit. * Have had a thymectomy performed \< 6 months prior to the Screening Visit or have a planned thymectomy during the study * Have any active or untreated malignant thymoma Additional exclusion criteria are defined in the protocol.
About the study
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.
What is being tested
- IMVT-1402 (drug)
- IMVT-1402 (drug)
- Placebo (drug)
- IMVT-1402 (drug)
Sponsor: Immunovant Sciences GmbH · Participants: 231 · Started: May 27, 2025
Contact the study team
- Central Study Contact · Phone: 18007970414
Official record on ClinicalTrials.gov — NCT07039916
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.