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Recruitment Complete
Sponsor ID
VIB0551.P3.S1

Myasthenia Gravis Inebilizumab TrialMINT

Sponsor ID
VIB0551.P3.S1
Clinicaltrials.gov ID
NCT04524273
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
238
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Baseline to Week 26

Secondary Outcome Measures

Change from baseline in Quantitative Myasthenia Gravis (QMG) scores.

Timeframe: Baseline to Week 52 for AChR-Ab+ population and Week 26 for the overall study population

Proportion of participants with both ≥ 3-point improvement from baseline in MG-ADL and did not initiate rescue therapy.

Timeframe: Baseline to Week 52 for AChR-Ab+ population and Week 26 for the overall study population

Change from baseline in MG-ADL

Timeframe: Baseline to Week 52 for AChR-Ab+ population and Week 26 for the overall study population

Time to first gMG exacerbation.

Timeframe: Day 1 to Week 52 for AChR-Ab+ population and Week 26 for the overall study population

Change from baseline in Myasthenia Gravis Composite (MGC) score.

Timeframe: Baseline to Week 52 for AChR-Ab+ population and Week 26 for the overall study population

Change from baseline in Myasthenia Gravis Quality of Life-15, revised (MGQOL-15r) score.

Timeframe: Baseline to Week 52 for AChR-Ab+ population and Week 26 for the overall study population

Patient Global Impression of Change (PGIC) score.

Timeframe: Week 52 for AChR-Ab+ population and Week 26 for the overall study population

Number of participants with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and treatment-emergent serious adverse events (TESAEs) during the RCP and OLP.

Timeframe: Up to 208 weeks

Proportion of participants with steroid tapered to ≤ 5 mg/day.

Timeframe: Week 52 for AChR-Ab+ population and Week 26 for the overall study population

Proportion of participants with a steroid dose reduction from baseline of ≥ 50%.

Timeframe: Baseline to Week 52 for AChR-Ab+ population and Week 26 for the overall study population

Proportion of participants achieving minimal symptom expression.

Timeframe: Week 26

Proportion of participants with anti-drug antibodies (ADAs) to inebilizumab

Timeframe: Up to 208 weeks

Titers of ADAs

Timeframe: Up to 208 weeks

Locations

Location
Status
Contact Us
Location
Viela Bio Investigative Site - 1010
Scottsdale, Arizona, United States, 85251
Status
Withdrawn
Location
Viela Bio Investigative Site - 1015
Orange, California, United States, 92868
Status
Active, not recruiting
Location
Viela Bio Investigative Site - 1013
Aurora, Colorado, United States, 80045
Status
Withdrawn
Location
Viela Bio Investigative Site - 1002
New Haven, Connecticut, United States, 06519
Status
Active, not recruiting
Location
Viela Bio Investigative Center - 1024
Washington, Washington DC, United States, 20010
Status
Active, not recruiting
Location
Viela Bio Investigative Site - 1005
Tampa, Florida, United States, 33612
Status
Active, not recruiting
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Study Info
Age
18+ years
Condition
  • Myasthenia Gravis
    • Sex
    All
    Trial Dates
    Oct 2020 - May 2024
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Diagnosis of MG with anti-AChR or anti-MuSK antibody. 2. MGFA Clinical Classification Class II, III, or IV. 3. MG-ADL score of 6 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items. 4. QMG score of 11 or greater. 5. 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.
    Exclusion Criteria:
    1. Receipt of the following medications within the 4 weeks prior to Day 1: a. Cyclosporine (except eye drops) b. Tacrolimus (except topical) c. Methotrexate 2. Current use of: a. Corticosteroids (Prednisone > 40 milligram (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 1. c. Azathioprine > 3 mg/kilogram (kg)/day d. Mycophenolate mofetil > 3 grams/day or mycophenolic acid > 1440 mg/day e. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.