Myasthenia Gravis Inebilizumab Trial

Phase 3

Recruiting

• Conditions: AChR-Ab+ or MuSK-Ab+ generalized Myasthenia Gravis

• Registration Number: JPRN-jRCT2021210003
• Lead Sponsor: Cardona Ritsuko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 16

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 at the time of screening and randomization between 6 and 10 with > 50% of this score attributed to non-ocular items, or an MG-ADL score 11 or greater.
4. QMG score of 11 or greater.
5. 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 at least 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 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.
Tacrolimus is allowed in Japan only, at a dose of < 3 mg/day, with continued use for at least 6 months prior
to randomization and no dose increase within 4 months prior to randomization.

Exclusion Criteria

1. Receipt within the 4 weeks prior to Day 1:
a. Cyclosporine (except eye drops)
b. Tacrolimus (except topical) (tacrolimus < 3 mg/day is allowed in Japan only)
c. Methotrexate
2. Current use of:
a. Prednisone > 40 mg/day or > 80 mg over a 2-day period (or equivalent dose of other corticosteroids)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at end of the RCP (Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population).