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Myasthenia Gravis Inebilizumab Trial (MINT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04524273
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : October 20, 2022
Sponsor:
Information provided by (Responsible Party):
Viela Bio (acquired by Horizon Therapeutics)

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 100 study sites. Approximately 270 subjects (188 AChR-Ab+ and 82 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 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 : June 30, 2023
Estimated Study Completion Date : December 28, 2024

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 randomized controlled period.

During the open-label period, participants will receive inebilizumab administered IV on Days 1 and 183.

 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 and 15 and on Day 183 of the randomized controlled period.

During the open label period, participants will receive inebilizumab administered IV on Days 1, 15 and 183.

 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 randomized controlled period.

During the open-label period, participants will receive inebilizumab administered IV on Days 1 and 183

 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 randomized controlled period.

During the open label period, participants will receive inebilizumab administered IV on Days 1, 15 and 183

 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 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population ]

Secondary Outcome Measures :
  1. Change in Quantitative Myasthenia Gravis (QMG) scores. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population ]
  2. Proportion of subjects with both (1) ≥ 3-point improvement in MG-ADL and (2) no use of rescue therapy. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population ]
  3. Change in MG-ADL at Week 26 in the AChR-Ab+ population. (AChR-Ab+ Only) [ Time Frame: Week 26 for AChR-Ab+ population ]
  4. Time to first exacerbation. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population ]
  5. Change in Myasthenia Gravis Composite (MGC) score. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for 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 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 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 randomized controlled period and open-label period. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for 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. Subjects must be on:

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

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

  2. Current use of:

    1. Prednisone > 40 mg/day or > 80 mg over a 2-day period (or equivalent dose of other corticosteroids)
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


Contacts
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Contact: Horizon Therapeutics 1-866-479-6742 clinicaltrials@horizontherapeutics.com

Locations
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Sponsors and Collaborators
Viela Bio (acquired by Horizon Therapeutics)
Investigators
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Study Director: Nishi Rampal, MD Horizon Therapeutics
More Information
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Responsible Party: Viela Bio (acquired by Horizon Therapeutics)
ClinicalTrials.gov Identifier: NCT04524273    
Other Study ID Numbers: VIB0551.P3.S1
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: October 20, 2022
Last Verified: October 2022

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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 Viela Bio (acquired by Horizon Therapeutics):
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