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- A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy, safety, and tolerability of iptacopan in patients with generalized Myasthenia Gravis (gMG), followed by an open label extension phase
Clinical Trial
A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy, safety, and tolerability of iptacopan in patients with generalized Myasthenia Gravis (gMG), followed by an open label extension phase
The main goal of this study is to look at the effectiveness and safety of an experimental drug called ?iptacopan? in people who have been diagnosed with generalized myasthenia gravis (gMG) and are positive for AChR antibodies.
Eligibility Criteria
- Inclusion Criteria: You are diagnosed with gMG with confirmed documentation and supported by a physical exam and confirmed positive for AChR-Antibodies at screening. You have an MG-ADL total score ?6 at screening and the day 1 visit, with more than 50% of the score due to nonocular symptoms. Exclusion Criteria: You had a thymectomy within 6 months of screening or plan to have one during the study. You have a history of cancer, treated or untreated, within the past 5 years.
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