Phase 3 Study to Test the Safety and Effectiveness of IMVT-1402 in Adults with Mild to Severe Generalized Myasthenia Gravis

What this Trial Is About

Researchers are studying the effects of IMVT-1402 in adults with mild to severe generalized myasthenia gravis, a condition affecting muscle strength. This Phase 3 trial aims to evaluate the efficacy, safety, and tolerability of IMVT-1402 as a treatment option compared to a placebo. The study is randomized and triple-blinded to ensure reliable results. Participants will receive one of two doses of IMVT-1402 or a placebo, all administered by subcutaneous injection once weekly. The treatment periods include an initial 12-week phase, followed by extended dosing periods of 14 weeks and 52 weeks for some groups. The study is designed to assess responses across these timeframes. During the trial, participants will be monitored through various assessments including the MG activities of daily living MG-ADL score and the Quantitative Myasthenia Gravis QMG score. The main outcome focuses on changes in MG-ADL from baseline to week 12. Safety and tolerability will also be tracked throughout the treatment and follow-up periods. The overall participation may last up to several months depending on the treatment group.

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