Myasthenia Gravis Inebilizumab Trial (MINT)

March 19, 2024 updated by: Amgen

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Actual)

238

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1023AAB
        • Viela Bio Investigative Site - 2001
      • Buenos Aires, Argentina, C1199ABB
        • VielaBio Investigative Site - 2002
      • Buenos Aires, Argentina, C1221ADC
        • Viela Bio Investigative Site - 2003
  • Belarus
      • Grodno, Belarus, 230030
        • Viela Bio Investigative Site - 5203
      • Minsk, Belarus, 220114
        • Viela Bio Investigative Site - 5204
      • Vitebsk, Belarus, 210009
        • Viela Bio Investigative Site - 5201
  • Brazil
      • Porto Alegre, Brazil, 90035-001
        • VielaBio Investigative Site - 2201
      • Porto Alegre, Brazil, 90840-440
        • VielaBio Investigative Site - 2203
      • Ribeirão Preto, Brazil, 14051-140
        • VielaBio Investigative Site - 2207
      • San Paolo, Brazil, 01228-000
        • VielaBio Investigative Site - 2206
      • São Paulo, Brazil, 08270-120
        • Viela Bio Investigative Site - 2205
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Viela Bio Investigative Site - 1102
    • Quebec
      • Montréal, Quebec, Canada, H2X 3J4
        • Viela Bio Investigative Site - 1101
      • Montréal, Quebec, Canada, H3A 2B4
        • Viela Bio Investigative Site - 1103
  • China
      • Beijing, China, 100029
        • Viela Bio Investigative Site 4009
      • Beijing, China, 100053
        • Viela Bio Investigative Site - 4007
      • Beijing, China, 100070
        • Viela Bio Investigative Site 4003
      • Guiyang, China, 550004
        • Viela Bio Investigative Site - 4005
      • Hunan, China, 410008
        • Viela Bio Investigative site 4010
      • Jinan, China, 250012
        • Viela Bio Investigative Site - 4011
      • Shanghai, China, 201107
        • Viela Bio Investigative Site - 4006
      • Suzhou, China, 215006
        • Viela Bio Investigative Site - 4008
      • Tianjin, China, 300052
        • Viela Bio Investigative Site - 4004
      • Xi'an, China, 710038
        • Viela Bio Investigative Site 4012
  • Denmark
      • Copenhagen, Denmark, 2100
        • Viela Bio Investigative Site - 5601
  • France
      • Lille Cedex, France, 59037
        • Viela Bio Investigative Site - 3003
      • Nice Cedex 01, France, 06001
        • Viela Bio Investigative Site - 3001
      • Strasbourg, France, 67098
        • Viela Bio Investigative Site - 3002
  • Germany
      • Essen, Germany, 45122
        • VielaBio Investigative Site - 3101
  • India
      • Bangalore, India, 560002
        • Viela Bio Investigative Site - 4104
      • Lucknow, India, 226014
        • Viela Bio investigative Site - 4105
      • Manipala, India, 576104
        • Viela Bio Investigative Site - 4103
      • Nashik, India, 422002
        • Viela Bio Investigative Site - 4102
      • Pune, India, 411004
        • Viela Bio Investigative Site - 4109
      • Surat, India, 395002
        • Viela Bio Investigative Site - 4101
    • Maharashtra
      • Nagpur, Maharashtra, India, 440012
        • Viela Bio Investigative Site - 4113
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Viela Bio Investigative Site - 4112
  • Italy
      • Milano, Italy, 20122
        • Viela Bio Investigative Site - 3204
      • Milano, Italy, 20133
        • Viela Bio Investigative Site - 3203
      • Pavia, Italy, 27100
        • Viela Bio Investigative Site - 3201
      • Rome, Italy, 168
        • Viela Bio Investigative Site - 3202
  • Japan
      • Chiba, Japan, 260-8677
        • Viela Bio Investigative Site - 4402
      • Chiba, Japan, 286-8520
        • Viela Bio Investigative Site - 4410
      • Fukuoka, Japan, 812-8582
        • Viela Bio Investigative Site 4409
      • Hanamaki, Japan, 025-0082
        • Viela Bio Investigative Site - 4401
      • Hokkaido, Japan, 041-8680
        • VielaBio Investigative Site - 4408
      • Hyōgo, Japan, 663-8501
        • Viela Bio Investigative Site - 4406
      • Miyagi, Japan, 983-8520
        • Viela Bio Investigative Site 4405
      • Moriguchi, Japan, 570-8507
        • Viela Bio Investigative Site - 4413
      • Morioka-shi, Japan, 020-8505
        • VielaBio Investigative Site - 4407
      • Saitama, Japan, 350-8550
        • Viela Bio Investigative Site - 4404
  • Korea, Republic of
      • Seoul, Korea, Republic of, 3722
        • Viela Bio Investigative Site - 4202
      • Seoul, Korea, Republic of, 5030
        • Viela Bio Investigative Site - 4203
      • Seoul, Korea, Republic of, 6351
        • Viela Bio Investigative Site - 4201
  • Poland
      • Katowice, Poland, 40-635
        • Viela Bio Investigative Site - 3302
      • Katowice, Poland, 40-752
        • Viela Bio Investigative Site - 3303
      • Kraków, Poland, 31-505
        • Viela Bio Investigative Site - 3301
      • Poznań, Poland
        • Viela Bio Investigative Site - 3311
      • Poznań, Poland, 60-693
        • Med Polonia Sp. z o.o - 3311
      • Warszawa, Poland, 01-868
        • Viela Bio Investigative Site - 3310
  • Russian Federation
      • Barnaul, Russian Federation, 656045
        • Viela Bio Investigative Site - 5303
      • Nizhny Novgorod, Russian Federation, 603126
        • Viela Bio Investigative Site - 5302
      • Novosibirsk, Russian Federation, 630087
        • Viela Bio Investigative Site - 5304
      • Rostov-on-Don, Russian Federation, 344015
        • Viela Bio Investigative Site - 5311
      • Rostov-on-Don, Russian Federation, 344022
        • Viela Bio Investigative Site - 5309
      • Saint Petersburg, Russian Federation, 197110
        • Viela Bio Investigative Site - 5308
      • Samara, Russian Federation, 443095
        • Viela Bio Investigative Site - 5305
      • Ufa, Russian Federation, 450083
        • Viela Bio Investigative Site - 5312
  • Spain
      • Badalona, Spain, 8916
        • Viela Bio Investigative Site - 3403
      • Barcelona, Spain, 8003
        • Viela Bio Investigative Site - 3402
      • Córdoba, Spain, 14004
        • Viela Bio Investigative Site - 3404
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Viela Bio investigative Site - 4605
      • New Taipei City, Taiwan, 235
        • Viela Bio Investigative Site 4608
      • Tainan, Taiwan, 704
        • Viela Bio Investigative Site - 4606
      • Taipei, Taiwan, 10002
        • Viela Bio Investigative Site - 4604
      • Taipei, Taiwan, 111
        • Viela Bio Investigative Site - 4603
      • Taipei, Taiwan, 11217
        • Viela Bio Investigative Site -4607
      • Taoyuan City, Taiwan, 333
        • Viela Bio Investigative Site - 4602
  • Turkey
      • Ankara, Turkey, 6230
        • Viela Bio Investigative Site - 3903
      • Kocaeli, Turkey, 41380
        • Viela Bio Investigative Site - 3905
      • İzmir, Turkey, 35100
        • Viela Bio Investigative Site - 3901
      • İzmir, Turkey, 35330
        • Viela Bio Investigative Site - 3902
  • Ukraine
      • Dnipro, Ukraine, 49005
        • Viela Bio Investigative Site - 5103
      • Ivano-Frankivs'k, Ukraine, 76493
        • Viela Bio Investigative Site - 5105
      • Lutsk, Ukraine, 43005
        • Viela Bio Investigative Site - 5104
      • Vinnytsia, Ukraine, 21050
        • Viela Bio Investigative Site - 5106
  • United States
    • California
      • Orange, California, United States, 92868
        • Viela Bio Investigative Site - 1015
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Viela Bio Investigative Site - 1002
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Viela Bio Investigative Center - 1024
    • Florida
      • Tampa, Florida, United States, 33612
        • Viela Bio Investigative Site - 1005
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Viela Bio Investigative Site - 1016
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Viela Bio Investigative Site - 1012
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Viela Bio Investigative Site - 1018
    • Ohio
      • Canton, Ohio, United States, 44718
        • Viela Bio Investigative Site - 1025
      • Cincinnati, Ohio, United States, 45219
        • Viela Bio Investigative Site - 1001
      • Columbus, Ohio, United States, 43210
        • Viela Bio Investigative Site - 1009
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Viela Bio Investigative Site - 1008
    • Texas
      • Austin, Texas, United States, 78759
        • Viela Bio Investigative Site - 1019
      • Houston, Texas, United States, 77030
        • Viela Bio Investigative Site - 1003
      • San Antonio, Texas, United States, 78229
        • Viela Bio Investigative Site - 1014
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Viela Bio Investigative Site - 1017
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Viela Bio Investigative Site - 1004
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Viela Bio Investigative Site - 1006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
Until Week 156 the overall study population, the AChR-Ab+ population, and for the MuSK-Ab+ population

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2020

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

November 29, 2027

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIB0551.P3.S1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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