Evaluating Safety and Effectiveness of Empasiprubart IV in Adults with AChR-Ab Positive Generalized Myasthenia Gravis

What this Trial Is About

Researchers are evaluating empasiprubart IV monotherapy in adults with AChR-Ab seropositive generalized myasthenia gravis gMG as part of the ADAPT Forward platform study. This Phase 2a trial aims to assess the safety, tolerability, and effectiveness of empasiprubart compared to placebo to find the best treatment approach that reduces side effects and improves quality of life for people with this condition. Eligible participants will be randomly assigned to receive either empasiprubart intravenously or a placebo during the double-blinded treatment period lasting up to 12 weeks. After this, all participants will receive open-label subcutaneous efgartigimod PH20 via pre-filled syringe during the safety follow-up period. The total study duration for each participant is approximately 45 weeks. During the study, participants will be monitored for adverse events and serious adverse events. Researchers will assess changes in muscle strength and daily living activities using scales like MG-ADL and QMG scores at various timepoints. Participants will have regular visits during the treatment and follow-up periods for assessments, safety monitoring, and to track treatment effects over time.

ADAPT Forward 2 - ISA2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis