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Clinical Trials/jRCT2021210003
jRCT2021210003Active, not recruitingNot Applicable

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study with Open-Label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults with Myasthenia Gravis (VIB0551.P3.S1)

Amgen Inc.0 sites16 target enrollmentStarted: August 18, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
16
Primary Endpoint
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Treatment Purpose
Masking
Double Blind

Eligibility Criteria

Ages
18age 0month 0week old over to No limit (—)
Sex
All

Inclusion Criteria

  • •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:
  • •a. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
  • •b. 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
  • •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

  • •Receipt of the following medications 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
  • •Current use of:
  • •a. Corticosteroids (prednisone > 40 mg/day or > 80 mg over a 2-day period [or equivalent dose of other corticosteroids])
  • •b. Acetylcholinesterase inhibitors (pyridostigmine) > 480 mg/day or unstable dose in the 2 weeks prior to Day
  • •c. Azathioprine > 3 mg/kg/day
  • •d. Mycophenolate mofetil > 3 g/day or mycophenolic acid > 1440 mg/day
  • •e. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.

Outcomes

Primary Outcomes

Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score

Time Frame: Week 26

Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 26 in the overall study population (ie, the AChR-Ab+ and MuSK-Ab+ populations)

Secondary Outcomes

  • Change from baseline in Quantitative Myasthenia Gravis (QMG) score at Week 26(Week 26)
  • Change from baseline in MG-ADL score at Week 26(Week 26)
  • Change from baseline in QMG score at Week 26(Week 26)
  • Change from baseline in Myasthenia Gravis Composite (MGC) score at Week 26(Week 26, Week 52)
  • Proportion of subjects with >= 3-point improvement in MG-ADL score at Week 26 and no use of rescue therapy(Week 26, Week 52)
  • Change from baseline in MG-ADL score at Week 52(Week 52)
  • Change from baseline in QMG score at Week 52(Week 52)
  • Change from baseline in Myasthenia Gravis Quality of Life-15 revised (MGQOL-15r) score at Week 26(Week 26, Week 52)
  • Patient Global Impression of Change score at Week 26(Week 26, Week 52)
  • Time to first MG exacerbation by Week 26(Week 26, Week 52)
  • Safety and tolerability of inebilizumab
  • Proportion of subjects with steroid tapered to <= 5 mg/day at Week 26(Week 26, Week 52)
  • Proportion of subjects in whom steroid dose was reduced by >= 50% by Week 26(Week 26, Week 52)
  • Proportion of subjects achieving minimal symptom expression(Week 26)
  • Anti-drug antibody status and titer during the study

Investigators

Sponsor
Amgen Inc.

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