Have any questions? 706-721-6582 or cts@augusta.edu
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
Clinical Trial
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
This study involves an investigational drug called ravulizumab (referred to as study drug). This study drug is being developed to treat generalized Myasthenia Gravis (gMG) by blocking complement activity. Complement activity is part of your immune system which fights against infections. In patients with gMG, abnormal complement activity is present, which causes damage to the structures in the body that are responsible for neuromuscular transmission. The purpose of this study is to evaluate the safety and efficacy of ravulizumab intravenous (IV; in the vein) in subjects with gMG.
Eligibility Criteria
- Inclusion Criteria: Have a documented history of generalized Myasthenia Gravis (MG) for at least 6 months before the screening visit with documentation stating that you are positive for AChR. Have a Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening and Myasthenia Gravis Activities of Daily Living (MG-ADL) profile of ? 6 at screening and baseline (Day 1). Exclusion Criteria: Have received treatment with rituximab within 6 months prior to Screening or have received treatment with eculizumab at any time. Have an active or untreated thymoma; a history of malignant thymoma unless deemed cured by adequate treatment and with no evidence of it reoccuring for ? 5 years before the screening visit; and a history of thymectomy within the 12 months prior to the screening visit.
RESEARCH. INNOVATION. DISCOVERY.