A Study to Test the Safety and Effectiveness of Aritinercept Injections for Adults With Generalized Myasthenia Gravis

What this Trial Is About

Researchers are evaluating aritinercept in adults diagnosed with generalized myasthenia gravis gMG, a condition characterized by muscle weakness. This study aims to assess the safety, how well patients tolerate aritinercept, its effectiveness, and how the drug is processed and affects the body. The study is a phase 12 clinical trial sponsored by Aurinia Pharmaceuticals Inc. and uses a randomized, double-blind, placebo-controlled design. Participants will be assigned randomly to receive either aritinercept or a placebo by subcutaneous injection during the double-blind treatment period. Following this, all participants will receive open-label aritinercept injections. The study uses a sequential model and includes treatment periods lasting up to 73 weeks. Throughout the study, participants will be monitored to track adverse events and evaluate changes in their myasthenia gravis symptoms using the MG-ADL scale. Safety and tolerability will be assessed from baseline through study completion. The total study duration for participants may last up to approximately 73 weeks, including follow-up visits and evaluations.

Study of Aritinercept in Patients With Generalized Myasthenia Gravis