Active — Not RecruitingPhase 3

Myasthenia Gravis Inebilizumab Trial

United States238 participantsStarted 2020-10-15

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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

Change From Baseline at Week 26 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the Overall Study Population

Timeframe: Baseline and Week 26

NCT IDNCT04524273

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-28

Results submitted2025-12-16

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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