Phase 2a Study Evaluating Empasiprubart IV Added to Efgartigimod IV for Adults With AChR-Ab Positive Generalized Myasthenia Gravis Showing Partial Response

What this Trial Is About

This research aims to evaluate the safety and therapeutic importance of empasiprubart as an add-on treatment to efgartigimod in adults with AChR-Ab seropositive generalized myasthenia gravis who have a partial clinical response to efgartigimod. It is part of the ADAPT Forward platform study, which looks at the safety and effectiveness of different drugs to find the best ways to reduce side effects and improve quality of life for people with myasthenia gravis. Participants first complete screening and then enter a run-in period part A receiving efgartigimod intravenously. Those eligible move on to the add-on period part B, receiving both efgartigimod and empasiprubart intravenously. Participants not eligible for part B continue to a safety follow-up period part C where they receive efgartigimod only. The total study duration is approximately 54 weeks per participant. Throughout the study, participants undergo assessments including monitoring for adverse events, measuring changes in MG-ADL and QMG scores, and evaluating clinical responses. Researchers track safety and efficacy up to 21 weeks during parts A and B. Participants have scheduled visits for treatment and safety evaluations, with ongoing observation through the safety follow-up period to monitor treatment effects and side effects.

ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod