Actively Recruiting
Phase 4 Study to Evaluate Oral Corticosteroid Reduction in Adults With Generalized Myasthenia Gravis Treated With Ravulizumab
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-04-09
75
Participants Needed
12
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a specific oral corticosteroid OCS tapering schedule to reduce steroid use in adults with acetylcholine receptor positive generalized myasthenia gravis gMG who are treated with intravenous ravulizumab. This phase 4, multicenter, single-arm study aims to assess both the effectiveness and safety of gradually lowering OCS doses while managing gMG symptoms. Participants will follow a predefined oral corticosteroid tapering schedule during the study period until they complete the tapering process. They will continue receiving ravulizumab as part of their standard medical care, along with prednisone or prednisolone as needed. The treatment period lasts up to approximately 32 weeks, focusing on reducing or discontinuing OCS while monitoring disease status. Throughout the study, researchers will assess how many participants can reduce their daily OCS dose to 5 mg or less, or stop it entirely, without worsening gMG for at least four weeks. They will also track changes in quality of life, daily living activities, and glucocorticoid toxicity. Participants will undergo regular evaluations and safety monitoring during the study, which runs from March 2026 to August 2027.
CONDITIONS
Brief Title
A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
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