Myasthenia Gravis Inebilizumab Trial

  • STATUS
    Recruiting
  • End date
    Dec 28, 2024
  • participants needed
    252
  • sponsor
    Viela Bio
Updated on 24 September 2020
corticosteroids
azathioprine
anti-musk antibody

Summary

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

Description

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.

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

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Eligibility

Yes No Not Sure

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)
Methotrexate
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 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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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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