Evaluate The Efficacy And Safety Of Alxn2050 In Adult Participants With Generalized Myasthenia Gravis
Posted Date: Feb 7, 2022
- Investigator: Hani Kushlaf
- Specialties: Neurology, Neuromuscular Disorders
- Type of Study: Drug
Approximately 70 eligible participants will be randomized on Day 1 in a 2:1:2 ratio to 1 of 3 treatment groups: ALXN2050 180 mg twice daily (bid) (Group 1), ALXN2050 120 mg bid (Group 2), or placebo (Group 3). Participants randomized to Group 1 and Group 2 will receive ALXN2050 during the Primary Evaluation Period (PEP; 8 weeks) and the Extended Treatment Period (ETP; 26 weeks). Participants in Group 3 will receive placebo treatment during the PEP and at the end of the PEP, will be rerandomized in a 1:1 ratio to receive either ALXN2050 180 mg bid (Group 3a) or ALXN2050 120 mg bid (Group 3b). During the Open-label Extension (OLE) Period (up to approximately 1.5 years), all participants will receive ALXN2050 and will be switched to the optimal dose of ALXN2050 if that dose has been identified during the study, as long as the participant has completed the first 34 weeks of treatment.
Myasthenia Gravis, Mg
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