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Myasthenia Gravis Inebilizumab Trial (MINT)

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ClinicalTrials.gov Identifier: NCT04524273
Recruitment Status : Active, not recruiting
First Posted : August 24, 2020
Last Update Posted : March 21, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

Condition or disease Intervention/treatment Phase
Myasthenia Gravis Drug: inebilizumab Drug: IV Placebo Phase 3

Detailed Description:

This study is a phase 3, randomized, double-blind, placebo-controlled study, to be conducted at approximately 120 study sites. Approximately 230 participants (188 acetylcholine receptor antibody positive [AChR-Ab+] and 42 muscle-specific tyrosine kinase antibody positive [MuSK-Ab+]) will be enrolled. Participants with Myasthenia Gravis (MG) who are positive for anti-AChR or anti-MuSK antibodies will be enrolled and analyzed. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with Myasthenia Gravis Foundation of America (MGFA) classification II, III, or IV disease, Myasthenia Gravis Activities of Daily Living (MG-ADL) score at screening and randomization between 6 and 10 with > 50% of this score attributed to non-ocular items, or an MG-ADL score >=11, Quantitative Myasthenia Gravis (QMG) score >= 11 at the time of screening and randomization, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study.

All subjects who complete the randomized controlled period (RCP) will have the option to enroll in a 3-year (156 weeks) open-label period.

Study acquired from Horizon in 2024.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study with Open-label Period
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind study in which the IV inebilizumab and the IV placebo are matching in appearance.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 30, 2020
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : November 29, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Inebilizumab, (AChR-Ab+) MG

Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the RCP.

Participants who elect to enter the open label phase (OLP) will receive inebilizumab administered IV on OLP Days 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

 Drug: inebilizumab
Participants will receive IV inebilizumab
Other Names:
  • MEDI-551
  • VIB0551
Placebo Comparator: Placebo, (AChR-Ab+) MG

Participants will receive placebo administered IV on Days 1, 15, and 183 of the RCP.

Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

 Drug: IV Placebo
Participants will receive IV placebo matched to inebilizumab
Experimental: Inebilizumab, (MuSK-Ab+) MG

Participants will receive inebilizumab administered IV on Days 1 and 15 of the RCP.

Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Day 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

 Drug: inebilizumab
Participants will receive IV inebilizumab
Other Names:
  • MEDI-551
  • VIB0551
Placebo Comparator: Placebo, (MuSK-Ab+) MG
Participants will receive placebo administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.
 Drug: IV Placebo
Participants will receive IV placebo matched to inebilizumab


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score. [ Time Frame: Week 26 for the overall study population ]

Secondary Outcome Measures :
  1. Change in Quantitative Myasthenia Gravis (QMG) scores. [ Time Frame: Week 26 for the overall study population, the AChR-Ab+ population and for the MuSK-Ab+ population ]
  2. Proportion of participants with both ≥ 3-point improvement in MG-ADL and did not initiate rescue therapy. [ Time Frame: Between Day 28 and Week 52 for AChR-Ab+ population and Day 28 and Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population ]
  3. Change in MG-ADL at Week 26 [ Time Frame: Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population ]
  4. Time to first gMG exacerbation. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population ]
  5. Change in Myasthenia Gravis Composite (MGC) score. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population ]
  6. Change in Myasthenia Gravis Quality of Life-15, revised (MGQOL-15r) score. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population ]
  7. Change in Patient Global Impression of Change (PGIC) score. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population ]
  8. 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. [ Time Frame: Until Week 156 the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
    2. 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
    3. 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:

    1. Cyclosporine (except eye drops)
    2. Tacrolimus (except topical)
    3. Methotrexate

  2. Current use of:

    1. Corticosteroids (Prednisone > 40 milligram (mg)/day or > 80 mg over a 2-day period (or equivalent dose of other corticosteroids).
    2. Acetylcholinesterase inhibitors (pyridostigmine) > 480 mg/day) or unstable dose in the 2 weeks prior to Day 1.
    3. Azathioprine > 3 mg/kilogram (kg)/day
    4. Mycophenolate mofetil > 3 grams/day or mycophenolic acid > 1440 mg/day
    5. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524273


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04524273    
Other Study ID Numbers: VIB0551.P3.S1
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: March 21, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Myasthenia Gravis
Additional relevant MeSH terms:
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Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases