Myasthenia Gravis Inebilizumab Trial (MINT)
Diseases of the Nervous System
What is the purpose of this trial?
This study is a phase 3, randomized, double-blind, placebo-controlled study, to be conducted at approximately 100 study sites. Approximately 270 subjects (188 AChR-Ab+ and 82 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.
- Ages18 years and older
- Trial withViela Bio, Inc.
- Start Date04/01/2021
- End Date06/30/2023
- Last Updated11/04/2021
- Study HIC#2000029503