Evaluating Telitacicept Compared to Placebo for Treating Generalized Myasthenia Gravis Including Open-Label Extension

What this Trial Is About

Generalized myasthenia gravis gMG is an autoimmune disorder that causes muscle weakness due to autoantibodies affecting nerve-to-muscle communication. This research evaluates the safety and effectiveness of telitacicept, a drug designed to target immune system proteins involved in the disease. The study is a Phase 3, randomized, double-blind, placebo-controlled trial with an open-label extension to further assess telitacicepts impact on gMG symptoms. Participants receive either telitacicept or a placebo through subcutaneous injections during the 24-week double-blind treatment period. Afterward, eligible participants may continue in a 48-week open-label extension where all receive telitacicept, followed by a variable extended open-label period until telitacicept is approved or further development ends. The study includes a 4-week screening phase before treatment and an 8-week follow-up after treatment completion. Throughout the trial, participants undergo assessments including muscle strength and daily living activity scores to measure treatment effects. Researchers monitor safety, quality of life, and muscle function using tools like the Myasthenia Gravis-Activities of Daily Living MG-ADL and Quantitative Myasthenia Gravis QMG scores. Study visits and evaluations track progress over the treatment and extension phases, with a total study duration depending on the participants time in the extended open-label period.

A Study of Telitacicept for the Treatment of Generalized Myasthenia Gravis (UPSTREAM MG)