Phase III Study to Test the Safety and Effectiveness of Remibrutinib Compared to Placebo in Adults With Generalized Myasthenia Gravis on Standard Treatment, Including an Open-Label Extension

What this Trial Is About

Researchers are evaluating the efficacy, safety, and tolerability of remibrutinib compared to a placebo in adult patients with Generalized Myasthenia Gravis gMG who are already on stable standard-of-care treatments. This multicenter Phase III study is randomized, double-blind, and placebo-controlled, aiming to provide important information about remibrutinibs impact on gMG symptoms. Participants will be randomly assigned to one of two groups one receiving remibrutinib tablets orally, and the other receiving matching placebo tablets, both during a 6-month core treatment period. Following this, participants can join an extension phase lasting up to 60 months, where all will receive open-label remibrutinib tablets orally. During the study, participants will undergo various assessments to monitor their symptoms and quality of life, including the Myasthenia Gravis Activity of Daily Living MG-ADL score and other clinical scales. Safety and tolerability will also be closely observed throughout the core and extension periods. The total duration of participation may extend up to nearly six years, including both study phases.

A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis