Myasthenia Gravis Trials

Prinicipal Investigator:
Ratna Bhavaraju-Sanka, MD

Study Coordinator:
Yogeet Kaur

MINT: Myasthenia Gravis INebilizumab Trial

Eligibility

1. Male or female subjects ≥ 18 years old.
2. Written informed consent and any locally required authorization
3. Diagnosis of MG
4. Subjects must be on:
a. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
b. One allowed non-steroidal IST, with continuous use for ≥ 6 months prior to randomization and no dose increase within 4 months prior to randomization, or
c. Combination of 1) corticosteroids with no dose increase within 4 weeks prior to randomization and 2) one allowed non-steroidal IST with continuous use for ≥ 6 months prior to randomization and no dose increase within 4 months prior to randomization.
5. Willing and able to comply with the protocol, complete study assessments, and return for follow-up visits.
6. Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective contraception method (Table 1) from the time of screening and for 6 months after the final dose of IP.
7. Non-sterilized males who are sexually active with a female partner of childbearing potential must use a condom from Day 1 for the duration of the study and for 3 months after the last dose of IP
8. Vital signs, electrocardiogram (ECG), and laboratory parameters within the normal ranges at screening, or, if outside normal ranges, deemed not clinically significant by the Investigator.

Treatment Duration
26 or 52 weeks depending on study group. Long-term extension available.