Myasthenia Gravis is a rare autoimmune disorder in which the immune system mistakenly attacks the connection between nerves and muscles, leading to varying degrees of muscle weakness. A specific form called AChR-Ab seropositive Generalized Myasthenia Gravis is identified by the presence of antibodies that target the acetylcholine receptor. The study evaluates two investigational medicines: Vyvgart, a solution that contains the active substance efgartigimod alfa and is administered by subcutaneous injection (a shot given under the skin), and Empasiprubart, which is given through an IV infusion (the medicine is slowly delivered into a vein). A matching placebo that looks the same but contains no active drug is also included.
The purpose of the study is to determine the safety and tolerability of these regimens in people with this condition. Participants are randomly assigned to receive either the active medication or the placebo, and neither the participants nor the study staff know which treatment is given. Over a period of several weeks, participants attend regular visits where vital signs, laboratory tests, and symptom questionnaires such as the MG-ADL (a simple survey that asks about daily activities affected by muscle weakness) are collected to monitor any side effects and changes in disease symptoms.
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