A Phase 2a Platform Study Evaluating Safety and Effectiveness of Multiple Treatments for Adults With Myasthenia Gravis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of different drug treatments in people with myasthenia gravis, a condition that affects muscle strength. This platform study uses a single master protocol to test multiple treatment regimens in separate groups called intervention-specific appendixes ISAs. The goal is to find the best treatments that reduce side effects and improve quality of life for patients with this disease. The study includes various treatment groups, such as those receiving intravenous infusions of efgartigimod, empasiprubart, or placebo, and subcutaneous administration of efgartigimod PH20 via pre-filled syringe. Each ISA has its own screening, treatment, and safety follow-up periods, which vary in length and design. Two ISAs are included one evaluating empasiprubart as add-on therapy to efgartigimod in people with partial responses, and another assessing empasiprubart monotherapy. Participants are involved in screening and treatment phases, with assessments of safety, tolerability, and effectiveness lasting up to about seven years depending on the ISA. Researchers will monitor clinical symptoms, side effects, and quality of life during and after treatment. The study aims to gather detailed information on how well these drug regimens work and their impact on patients living with myasthenia gravis.

ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis