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- A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis
Clinical Trial
A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis
TAK-079, also called 'study drug,' is being tested as a possible treatment for myasthenia gravis. The purpose of this study is to see how safe and effective the study drug is, how long it stays in a patient's blood, and to collect information on how the body reacts to the study drug during the 32 weeks of study participation.
Eligibility Criteria
- Inclusion Criteria: Have a diagnosis of myasthenia gravis (MG) supported by a positive test for anti-AChR or anti-MuSK antibodies at screening. 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 with at least 4 points not linked to ocular symptoms. Exclusion Criteria: Have received treatment with rituximab, belimumab, eculizumab, or any monoclonal antibody for immunomodulation within 6 months before first dosing. Have a history of thymoma or other thymic neoplasms; and a history of thymectomy within the 12 months prior to the screening visit.
RESEARCH. INNOVATION. DISCOVERY.