A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)
Description
Phase
N/AInclusion and Exclusion Criteria
- - Male or female patients ≥18 years old - Diagnosis of MG made by the following tests:
- Positive serologic test for anti-AChR Abs as confirmed at screening, and
- One of the following:
- History of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation, or
- History of positive anticholinesterase test, e.g. edrophonium chloride test, or
- Subject has demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician. - MGFA Clinical Classification Class II to IV at screening. - MG-ADL total score must be ≥6 at screening. - Subjects who have:
- Failed treatment with at least two immunosuppressive agents. Or,
- Failed treatment with at least one immunosuppressive agent and require chronic plasma exchange or IVIg Key
- History of thymoma or other neoplasms of the thymus
- History of thymectomy within 12 months prior to screening
- MGFA Class I or MG crisis at screening (MGFA Class V)
- Use of rituximab within 6 months prior to screening
- Use of IVIg or PE within 4 weeks prior to screening
Sites
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