Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.
This study is a phase 3, randomized, double-blind, placebo-controlled study, to be conducted at approximately 100 study sites. Approximately 252 subjects (172 AChR-Ab+ and 80 MuSK-Ab+) will be enrolled. Patients with MG who are positive for anti-AChR or anti-MuSK antibodies will be enrolled and analyzed separately as 2 populations: (1) AChR-Ab+ and (2) MuSK-Ab+. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with MGFA classification II, III, or IV disease, MG-ADL score 6, QMG score 11, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study.
All subjects who complete the randomized controlled period will have the option to enroll in a 1.5-year open-label period.
|Treatment||IV placebo, Inebilizumab|
|Clinical Study Identifier||NCT04524273|
|Last Modified on||24 September 2020|
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