Myasthenia Gravis Inebilizumab Trial

• Status: Recruiting
• Trial end date: 2024-12-28
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Viela Bio

Criteria

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)