Myasthenia Gravis Inebilizumab Trial (MINT)

May 1, 2026 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 2023.

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

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

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
      • São Paulo, Brazil, 08270-120
        • Viela Bio Investigative Site - 2205
      • São Paulo, Brazil, 01228-000
        • VielaBio Investigative Site - 2206
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Viela Bio Investigative Site - 1102
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • Viela Bio Investigative Site - 1101
      • Montreal, 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, France, 59037
        • Viela Bio Investigative Site - 3003
      • Nice, 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
      • Manipal, 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
      • Nagpur, Maharashtra, India, 440003
        • Viela Bio Investigative Site - 4107
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Viela Bio Investigative Site - 4112
  • Italy
      • Milan, Italy, 20122
        • Viela Bio Investigative Site - 3204
      • Milan, 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
      • Fukuoka, 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, Japan, 020-8505
        • VielaBio Investigative Site - 4407
      • Saitama, Japan, 350-8550
        • Viela Bio Investigative Site - 4404
  • Poland
      • Katowice, Poland, 40-635
        • Viela Bio Investigative Site - 3302
      • Katowice, Poland, 40-752
        • Viela Bio Investigative Site - 3303
      • Krakow, Poland, 31-505
        • Viela Bio Investigative Site - 3301
      • Poznan, Poland, 60-693
        • Med Polonia Sp. z o.o - 3311
      • Warsaw, Poland, 01-868
        • Viela Bio Investigative Site - 3310
  • Russia
      • Barnaul, Russia, 656045
        • Viela Bio Investigative Site - 5303
      • Nizhny Novgorod, Russia, 603126
        • Viela Bio Investigative Site - 5302
      • Novosibirsk, Russia, 630087
        • Viela Bio Investigative Site - 5304
      • Rostov-on-Don, Russia, 344015
        • Viela Bio Investigative Site - 5311
      • Rostov-on-Don, Russia, 344022
        • Viela Bio Investigative Site - 5309
      • Saint Petersburg, Russia, 197110
        • Viela Bio Investigative Site - 5308
      • Samara, Russia, 443095
        • Viela Bio Investigative Site - 5305
      • Ufa, Russia, 450083
        • Viela Bio Investigative Site - 5312
    • Altayskiy Kray
      • Barnaul, Altayskiy Kray, Russia, 656043
        • Viela Bio Investigative Site - 5313
  • South Korea
      • Seoul, South Korea, 3722
        • Viela Bio Investigative Site - 4202
      • Seoul, South Korea, 5030
        • Viela Bio Investigative Site - 4203
      • Seoul, South Korea, 6351
        • Viela Bio Investigative Site - 4201
  • 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 (Türkiye)
      • Ankara, Turkey (Türkiye), 6230
        • Viela Bio Investigative Site - 3903
      • Izmir, Turkey (Türkiye), 35100
        • Viela Bio Investigative Site - 3901
      • Izmir, Turkey (Türkiye), 35330
        • Viela Bio Investigative Site - 3902
      • Kocaeli, Turkey (Türkiye), 41380
        • Viela Bio Investigative Site - 3905
  • Ukraine
      • Dnipro, Ukraine, 49005
        • Viela Bio Investigative Site - 5103
      • Dnipro, Ukraine, 49089
        • Viela Bio Investigative Site - 5108
      • Ivano-Frankivsk, 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 D.C., District of Columbia, United States, 20010
        • Viela Bio Investigative Center - 1024
    • Florida
      • Tampa, Florida, United States, 33612
        • Viela Bio Investigative Site - 1005
    • 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
Measure Description
Time Frame
Change From Baseline at Week 26 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the Overall Study Population
Time Frame: Baseline and Week 26

MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease

Outcome measure is reported for the overall population.
Baseline and Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score at Week 26 in the Overall Study Population
Time Frame: Baseline and Week 26

The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease.

Outcome measure is reported for the overall population.
Baseline and Week 26
Change From Baseline at Week 26 in MG-ADL Score in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: Baseline and Week 26

MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease.

Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Baseline and Week 26
Change From Baseline in QMG Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: Baseline and Week 26

The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease.

Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Baseline and Week 26
Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in the Overall Study Population
Time Frame: Up to Week 26

MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease.

The protocol-allowed rescue therapy options included intravenous immunoglobulin (IVIg) and therapeutic plasma exchange (PLEX).

Outcome measure is reported for the overall population.
Up to Week 26
Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 26 and no Use of Rescue Therapy Between Day 28 and Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: Up to Week 26

MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease.

The protocol-allowed rescue therapy options included IVIg and PLEX.

Outcome measure is reported in Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Up to Week 26
Percentage of Participants With Both ≥ 3-point Improvement in MG-ADL Score at Week 52 and no Use of Rescue Therapy Between Day 28 and Week 52 in Anti-AChR-Ab+ Population
Time Frame: Up to Week 52

MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease.

The protocol-allowed rescue therapy options included IVIg and PLEX.

Outcome measure is reported for the Anti-AChR-Ab+ population.
Up to Week 52
Percentage of Participants With no Use of Rescue Therapy Between Day 28 and Week 52 in Anti-AChR-Ab+ Population
Time Frame: Up to Week 52

The protocol-allowed rescue therapy options included corticosteroids, IVIg and PLEX.

Outcome measure is reported for the Anti-AChR-Ab+ population.
Up to Week 52
Change From Baseline in MG-ADL Score at Week 52 in the Anti-AChR-Ab+ Population
Time Frame: Baseline and Week 52

MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease.

Outcome measure is reported for the Anti-AChR-Ab+ population.
Baseline and Week 52
Change From Baseline in QMG Score at Week 52 in the Anti-AChR-Ab+ Population
Time Frame: Baseline and Week 52

The QMG score is a validated outcome comprised of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item). Each item has a possible score of between 0 and 3 points. The total score range is 0-39 points, with higher score indicating more severe disease.

Outcome measure is reported for the Anti-AChR-Ab+ population.
Baseline and Week 52
Change From Baseline in Myasthenia Gravis Composite (MGC) Score at Week 26 in the Overall Study Population
Time Frame: Baseline and Week 26

The MGC score consists of test items from MG-ADL score and the QMG score, with weighted response options. Scores range from 0-50, with higher scores indicating worse disease manifestations.

Outcome measure is reported for the overall population.
Baseline and Week 26
Change From Baseline in MGC Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: Baseline and Week 26

The MGC score consists of test items from MG-ADL score and the QMG score, with weighted response options. Scores range from 0-50, with higher scores indicating worse disease manifestations.

Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Baseline and Week 26
Change From Baseline in MGC Score at Week 52 in Anti-AChR-Ab+ Population
Time Frame: Baseline and Week 52

The MGC score consists of test items from MG-ADL score and the QMG score, with weighted response options. Scores range from 0-50, with higher scores indicating worse disease manifestations.

Outcome measure is reported for the Anti-AChR-Ab+ population.
Baseline and Week 52
Change From Baseline in Myasthenia Gravis Quality of Life-15, Revised (MGQOL-15r) Score at Week 26 in the Overall Study Population
Time Frame: Baseline and Week 26

MGQOL-15r score is a validated, patient-scored instrument, which measures the impact of MG on health-related quality of life (HRQoL). The 15 items in the questionnaire evaluate mobility (9 items), symptoms (3 items), general contentment (1 item), and emotional well-being (2 items) domains. Each item is rated on a 3-point scale ranging from 0 ("not at all") to 2 ("very much") based on their experience "over the past few weeks." Items scores are summed to generate a total score ranging from 0-45, with higher score indicating worse HRQoL.

Outcome measure is reported for the overall population.
Baseline and Week 26
Change From Baseline in MGQOL-15r Score at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: Baseline and Week 26

MGQOL-15r score is a validated, patient-scored instrument, which measures the impact of MG on health-related quality of life (HRQoL). The 15 items in the questionnaire evaluate mobility (9 items), symptoms (3 items), general contentment (1 item), and emotional well-being (2 items) domains. Each item is rated on a 3-point scale ranging from 0 ("not at all") to 2 ("very much") based on their experience "over the past few weeks." Items scores are summed to generate a total score ranging from 0-45, with higher score indicating worse HRQoL.

Outcome measure is reported in Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Baseline and Week 26
Change From Baseline in MGQOL-15r Score at Week 52 in Anti-AChR-Ab+ Population
Time Frame: Baseline and Week 52

MGQOL-15r score is a validated, patient-scored instrument, which measures the impact of MG on health-related quality of life (HRQoL). The 15 items in the questionnaire evaluate mobility (9 items), symptoms (3 items), general contentment (1 item), and emotional well-being (2 items) domains. Each item is rated on a 3-point scale ranging from 0 ("not at all") to 2 ("very much") based on their experience "over the past few weeks." Items scores are summed to generate a total score ranging from 0-45, with higher score indicating worse HRQoL.

Outcome Measure is reported for the Anti-AChR-Ab+ population.
Baseline and Week 52
Percentage of Participants With Patient Global Impression of Change (PGIC) Scores at Week 26 in the Overall Study Population
Time Frame: Week 26

The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a participant's rating of overall improvement. Participant rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse",

Outcome measure is reported for the overall population.
Week 26
Percentage of Participants With PGIC Scores at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: Week 26

The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a participant's rating of overall improvement. Participants rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".

Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Week 26
Percentage of Participants With PGIC Scores at Week 52 in Anti-AChR-Ab+ Population
Time Frame: Week 52

The self-report measure PGIC score reflects a participant's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a participant's rating of overall improvement. participants rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".

Outcome measure is reported for the Anti-AChR-Ab+ population.
Week 52
Percentage of Participants Experiencing Exacerbation by Week 26 in the Overall Study Population
Time Frame: Up to Week 26

An exacerbation was defined as one of the following:

  • Use of protocol defined rescue therapy, or
  • Myasthenic crisis, defined as worsening of myasthenic weakness requiring intubation or non-invasive ventilation to avoid intubation, except when these measures are employed during routine postoperative management, or
  • Significant symptomatic worsening to a score of 3 or a 2-point worsening from baseline on any one of the individual MG-ADL items other than double vision or eyelid droop.

Outcome measure is reported for the overall population.
Up to Week 26
Percentage of Participants Experiencing Exacerbation by Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: Up to Week 26

An exacerbation was defined as one of the following:

  • Use of protocol defined rescue therapy, or
  • Myasthenic crisis, defined as worsening of myasthenic weakness requiring intubation or non-invasive ventilation to avoid intubation, except when these measures are employed during routine postoperative management, or
  • Significant symptomatic worsening to a score of 3 or a 2-point worsening from baseline on any one of the individual MG-ADL items other than double vision or eyelid droop.

Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Up to Week 26
Percentage of Participants Experiencing Exacerbation by Week 52 in Anti-AChR-Ab+ Population
Time Frame: Up to Week 52

An exacerbation was defined as one of the following:

  • Use of protocol defined rescue therapy, or
  • Myasthenic crisis, defined as worsening of myasthenic weakness requiring intubation or non-invasive ventilation to avoid intubation, except when these measures are employed during routine postoperative management, or
  • Significant symptomatic worsening to a score of 3 or a 2-point worsening from baseline on any one of the individual MG-ADL items other than double vision or eyelid droop.

Outcome measure is reported for the Anti-AChR-Ab+ population.
Up to Week 52
Percentage of Participants Achieving Minimal Symptom Expression (MSE) at Week 26
Time Frame: From Day 28 to Week 26

MSE was defined as MG-ADL= 0 or 1.

Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK+ populations.
From Day 28 to Week 26
Percentage of Participants With Steroid Tapered to ≤ 5 mg/Day Steroid at Week 26 in the Overall Study Population
Time Frame: Week 26
Outcome measure is reported for the overall population.
Week 26
Percentage of Participants With Steroid Tapered to ≤ 5 mg/Day Steroid at Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: Week 26
Outcome measure is reported in Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Week 26
Percentage of Participants With Steroid Tapered to ≤ 5 mg/Day Steroid at Week 52 in Anti-AChR-Ab+ Population
Time Frame: Week 52
Outcome measure is reported for the Anti-AChR-Ab+ population.
Week 52
Percentage of Participants Who Achieved ≥ 50% Steroid Reduction at Week 26 in the Overall Study Population
Time Frame: Week 26
Outcome measure is reported for the overall population.
Week 26
Percentage of Participants Who Achieved ≥ 50% Steroid Reduction at Week 26 in the Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: Week 26
Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Week 26
Percentage of Participants Who Achieved ≥ 50% Steroid Reduction at Week 52 in the Anti-AChR-Ab+ Population
Time Frame: Week 52
Outcome measure is reported for the Anti-AChR-Ab+ population.
Week 52
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs), AE of Special Interest (AESIs) and Serious TEAEs (SAEs).
Time Frame: For RCP AE reporting: from Day 1 to the end of RCP or cutoff date (up to 65.4 weeks)

An AE is any untoward medical occurrence associated with the use of the IP, whether or not it is considered related. Clinically significant changes from baseline in clinical laboratory results, vital signs and ECGs were also reported as AEs.

An AESI is an event of medical interest specific to the understanding of the IP and which may require close monitoring and collection of additional information.

A SAE is considered "serious" if it results in any of the following outcomes:

  • Death;
  • A life-threatening AE. An event is considered "life-threatening" if its occurrence places the patient or subject at immediate risk of death;
  • Inpatient hospitalization or prolongation of existing hospitalization;
  • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
  • A congenital anomaly/birth defect;
  • May require medical or surgical intervention to prevent one of the outcomes listed in this definition.
For RCP AE reporting: from Day 1 to the end of RCP or cutoff date (up to 65.4 weeks)
Percentage of Participants With Anti-drug Antibodies (ADA) by Week 26 in the Overall Study Population
Time Frame: From Baseline to Week 26

Treatment emergent ADA were defined as ADA positive post-baseline only or boosted pre-existing ADA titer.

Outcome measure is reported for the overall population.
From Baseline to Week 26
Percentage of Participants With ADA by Week 26 in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: From Baseline to Week 26

Treatment emergent ADA were defined as ADA positive post-baseline only or boosted pre-existing ADA titer.

Outcome measure is reported in Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
From Baseline to Week 26
Percentage of Participants With ADA by Week 52 in Anti-AChR-Ab+ Population
Time Frame: From Baseline to Week 52

Treatment emergent ADA were defined as ADA positive post-baseline only or boosted pre-existing ADA titer.

Outcome measure is reported for the Anti-AChR-Ab+ population.
From Baseline to Week 52
Time to Maximum Serum Concentration (Tmax) of Inebilizumab in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: Days 1 and 15 for Anti-MuSK-Ab+ population; Days 1, 15 and 183 (Week 26) for Anti-AChR-Ab+ population

On inebilizumab dosing days, inebilizumab pharmacokinetic (PK) serum samples were collected pre-dose and approximately 15 minutes (± 5 minutes) after completion of the IP infusion.

Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Days 1 and 15 for Anti-MuSK-Ab+ population; Days 1, 15 and 183 (Week 26) for Anti-AChR-Ab+ population
Maximum Observed Serum Concentration (Cmax) of Inebilizumab in Anti-AChR-Ab+ and Anti-MuSK-Ab+ Populations
Time Frame: Days 1 and 15 for Anti-MuSK-Ab+ population; Days 1, 15 and 183 (Week 26) for Anti-AChR-Ab+ population

On inebilizumab dosing days, inebilizumab PK serum samples were collected pre-dose and approximately 15 minutes (± 5 minutes) after completion of the IP infusion.

Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Days 1 and 15 for Anti-MuSK-Ab+ population; Days 1, 15 and 183 (Week 26) for Anti-AChR-Ab+ population
Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab
Time Frame: Days 1 and 15 for Anti-MuSK-Ab+ population; Days 1, 15 and 183 (Week 26) for Anti-AChR-Ab+ population

On inebilizumab dosing days, inebilizumab PK serum samples were collected pre-dose and approximately 15 minutes (± 5 minutes) after completion of the IP infusion.

Outcome measure is reported for the Anti-AChR-Ab+ and Anti-MuSK-Ab+ populations.
Days 1 and 15 for Anti-MuSK-Ab+ population; Days 1, 15 and 183 (Week 26) for Anti-AChR-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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

October 15, 2020

Primary Completion (Actual)

May 28, 2024

Study Completion (Estimated)

June 7, 2029

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)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

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.

Clinical Trials on Myasthenia Gravis

Clinical Trials on inebilizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe