Myasthenia Gravis Inebilizumab Trial

  • End date
    Dec 28, 2024
  • participants needed
  • sponsor
    Viela Bio
Updated on 24 September 2020
Jack Ratchford, MD
Primary Contact
Viela Bio Investigative Site (5.5 mi away) Contact
anti-musk antibody


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.

Treatment IV placebo, Inebilizumab
Clinical Study IdentifierNCT04524273
SponsorViela Bio
Last Modified on24 September 2020

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Myasthenia Gravis generalised or Myasthenia Gravis (Chronic Weakness) or Myasthenia Gravis?
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
Subjects must be on
Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
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
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

Receipt within the 4 weeks prior to Day 1
Cyclosporine (except eye drops)
Tacrolimus (except topical)
Current use of
Prednisone > 40 mg/day or > 80 mg over a 2-day period (or equivalent dose of other corticosteroids)
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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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