Myasthenia Gravis Inebilizumab Trial
Myasthenia Gravis Inebilizumab Trial
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.
Inclusion Criteria:

 1. Diagnosis of MG with anti-AChR or anti-MuSK antibody.

 2. MGFA Clinical Classification Class II, III, or IV.

 3. MG-ADL score of 6 or greater at screening and at randomization with > 50% of this
 score attributed to non-ocular items.

 4. QMG score of 11 or greater.

 5. Subjects must be on:

 1. Corticosteroids only, with no dose increase within 4 weeks prior to
 randomization, or

 2. One allowed non-steroidal IST, with continuous use for at least 6 months prior to
 randomization and no dose increase within 4 months prior to randomization, or

 3. 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 at
 least 6 months prior to randomization and no dose increase within 4 months prior
 to randomization.

 Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate
 mofetil, and mycophenolic acid.

 Exclusion Criteria:

 1. Receipt within the 4 weeks prior to Day 1:

 1. Cyclosporine (except eye drops)

 2. Tacrolimus (except topical)

 3. Methotrexate

 2. Current use of:

 1. Prednisone > 40 mg/day or > 80 mg over a 2-day period (or equivalent dose of
 other corticosteroids)