Status:
ACTIVE_NOT_RECRUITING
Myasthenia Gravis Inebilizumab Trial
Lead Sponsor:
Amgen
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.
Detailed Description
This study is a phase 3, randomized, double-blind, placebo-controlled study, to be conducted at approximately 120 study sites. Approximately 230 participants (188 acetylcholine receptor antibody posit...
Eligibility Criteria
Inclusion
- Diagnosis of MG with anti-AChR or anti-MuSK antibody.
- MGFA Clinical Classification Class II, III, or IV.
- MG-ADL score of 6 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items.
- QMG score of 11 or greater.
- Participants must be on:
- Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
- One allowed non-steroidal immunosuppressive therapy (IST), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or
- 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
- Receipt of the following medications within the 4 weeks prior to Day 1:
- Cyclosporine (except eye drops)
- Tacrolimus (except topical)
- Methotrexate
- Current use of:
- Corticosteroids (Prednisone \> 40 milligram (mg)/day or \> 80 mg over a 2-day period (or equivalent dose of other corticosteroids).
- Acetylcholinesterase inhibitors (pyridostigmine) \> 480 mg/day) or unstable dose in the 2 weeks prior to Day 1.
- Azathioprine \> 3 mg/kilogram (kg)/day
- Mycophenolate mofetil \> 3 grams/day or mycophenolic acid \> 1440 mg/day
- Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2027
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04524273
Start Date
October 15 2020
End Date
November 29 2027
Last Update
February 20 2025
Active Locations (104)
Enter a location and click search to find clinical trials sorted by distance.
1
Viela Bio Investigative Site - 1015
Orange, California, United States, 92868
2
Viela Bio Investigative Site - 1002
New Haven, Connecticut, United States, 06519
3
Viela Bio Investigative Center - 1024
Washington D.C., District of Columbia, United States, 20010
4
Viela Bio Investigative Site - 1005
Tampa, Florida, United States, 33612