Myasthenia Gravis Inebilizumab Trial (MINT)

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

Tracking Information

• First Submitted Date: August 10, 2020
• First Posted Date: August 24, 2020
• Last Update Posted Date: March 21, 2024
• Actual Study Start Date: August 30, 2020
• Estimated Primary Completion Date: August 1, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 7, 2024): Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score. [ Time Frame: Week 26 for the overall study population ]
• Original Primary Outcome Measures (submitted: August 19, 2020): 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 ]

Current Secondary Outcome Measures (submitted: March 7, 2024)

• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]

Original Secondary Outcome Measures (submitted: August 19, 2020)

• Change in Quantitative Myasthenia Gravis (QMG) scores. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population ]
• 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 ]
• Change in MG-ADL at Week 26 in the AChR-Ab+ population. (AChR-Ab+ Only) [ Time Frame: Week 26 for AChR-Ab+ population ]
• Time to first exacerbation. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population ]
• Change in Myasthenia Gravis Composite (MGC) score. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population ]
• 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 ]
• Change in Patient Global Impression of Change (PGIC) score. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ 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 randomized controlled period and open-label period. [ Time Frame: Week 52 for AChR-Ab+ population and Week 26 for MuSK-Ab+ population ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Myasthenia Gravis Inebilizumab Trial
• 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
• Brief Summary: Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

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 Type: Interventional
• Study Phase: Phase 3

Study Design

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

• Condition: Myasthenia Gravis

Intervention

• Drug: inebilizumab
  Participants will receive IV inebilizumab
  Other Names:

  • MEDI-551
  • VIB0551
• Drug: IV Placebo
  Participants will receive IV placebo matched to inebilizumab

Study Arms

• 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.

  Intervention: Drug: inebilizumab
• 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.

  Intervention: Drug: IV Placebo
• 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.

  Intervention: Drug: inebilizumab
• 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.
  Intervention: Drug: IV Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 5, 2024): 238
• Original Estimated Enrollment (submitted: August 19, 2020): 252
• Estimated Study Completion Date: November 29, 2027
• Estimated Primary Completion Date: August 1, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Belarus, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United States
• Removed Location Countries: Israel

Administrative Information

• NCT Number: NCT04524273
• Other Study ID Numbers: VIB0551.P3.S1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Amgen
• Original Responsible Party: Viela Bio
• Current Study Sponsor: Amgen
• Original Study Sponsor: Viela Bio
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: March 2024