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
Immunovant Sciences GmbH
231 participants
May 27, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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)
Exclusion Criteria3
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)
* 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)
• Placebo SC QW for 12 weeks (Period 1)
* Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3)
Locations(75)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07039916