Evaluating Claseprubart Treatment for Generalized Myasthenia Gravis in Adults A Phase 3 Randomized Study

What this Trial Is About

Researchers are evaluating the drug claseprubart in adults with generalized myasthenia gravis gMG in this Phase 3 clinical trial. The study aims to assess the effectiveness, safety, and tolerability of claseprubart for improving daily living activities affected by gMG. Participants must have confirmed gMG with specific antibody and clinical test criteria and meet certain severity scores. The study includes several periods an initial screening lasting up to 12 weeks to determine eligibility a 17-week randomized, blinded, controlled treatment period where participants receive either an intravenous loading dose of claseprubart or placebo followed by subcutaneous injections every two weeks an optional extended treatment phase lasting 104 weeks, including both blinded and open-label extensions and a 40-week safety follow-up period. Participants may receive different dosing schedules or placebo as part of the randomized groups. During the study, participants will undergo various assessments such as the Myasthenia Gravis Activities of Daily Living MG-ADL scale, Quantitative Myasthenia Gravis QMG scale, and Myasthenia Gravis Composite MGC scale to measure symptom changes. Safety is monitored throughout all study periods by tracking adverse events, blood tests including complement levels and drug antibody presence, and serum drug concentrations. The total duration of participation can extend up to approximately 161 weeks including all phases.

A Phase 3 Study to Evaluate Claseprubart in Adults With Generalized Myasthenia Gravis (EMERGE)