Myasthenia Gravis Inebilizumab Trial

Last updated: February 14, 2025
Sponsor: Amgen
Overall Status: Active - Not Recruiting

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Sarcopenia

Treatment

IV Placebo

inebilizumab

Clinical Study ID

NCT04524273
VIB0551.P3.S1
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 thisscore attributed to non-ocular items.

  4. QMG score of 11 or greater.

  5. Participants must be on:

  6. Corticosteroids only, with no dose increase within 4 weeks prior torandomization, or

  7. One allowed non-steroidal immunosuppressive therapy (IST), with continuous usefor at least 6 months prior to randomization and no dose increase within 4months prior to randomization, or

  8. Combination of (1) corticosteroids with no dose increase within 4 weeks priorto randomization and (2) one allowed non-steroidal IST with continuous use forat least 6 months prior to randomization and no dose increase within 4 monthsprior to randomization.

Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.

Exclusion

Exclusion Criteria:

  1. Receipt of the following medications within the 4 weeks prior to Day 1:

  2. Cyclosporine (except eye drops)

  3. Tacrolimus (except topical)

  4. Methotrexate

  5. Current use of:

  6. Corticosteroids (Prednisone > 40 milligram (mg)/day or > 80 mg over a 2-dayperiod (or equivalent dose of other corticosteroids).

  7. Acetylcholinesterase inhibitors (pyridostigmine) > 480 mg/day) or unstable dosein the 2 weeks prior to Day 1.

  8. Azathioprine > 3 mg/kilogram (kg)/day

  9. Mycophenolate mofetil > 3 grams/day or mycophenolic acid > 1440 mg/day

  10. Any IST, alone or in combination with corticosteroids, except for azathioprine,mycophenolate mofetil, and mycophenolic acid.

Study Design

Total Participants: 238
Treatment Group(s): 2
Primary Treatment: IV Placebo
Phase: 3
Study Start date:
October 15, 2020
Estimated Completion Date:
November 29, 2027

Study 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.

Connect with a study center

  • Viela Bio Investigative Site - 2001

    Buenos Aires, C1023AAB
    Argentina

    Site Not Available

  • Viela Bio Investigative Site - 2003

    Buenos Aires, C1221ADC
    Argentina

    Site Not Available

  • VielaBio Investigative Site - 2002

    Buenos Aires, C1199ABB
    Argentina

    Site Not Available

  • Viela Bio Investigative Site - 5203

    Grodno, 230030
    Belarus

    Site Not Available

  • Viela Bio Investigative Site - 5202

    Minsk, 220045
    Belarus

    Site Not Available

  • Viela Bio Investigative Site - 5204

    Minsk, 220114
    Belarus

    Site Not Available

  • Viela Bio Investigative Site - 5201

    Vitebsk, 210009
    Belarus

    Site Not Available

  • VielaBio Investigative Site - 2201

    Porto Alegre, 90035-001
    Brazil

    Site Not Available

  • VielaBio Investigative Site - 2203

    Porto Alegre, 90840-440
    Brazil

    Site Not Available

  • VielaBio Investigative Site - 2207

    Ribeirão Preto, 14051-140
    Brazil

    Site Not Available

  • VielaBio Investigative Site - 2206

    San Paolo, 01228-000
    Brazil

    Site Not Available

  • Viela Bio Investigative Site - 2205

    São Paulo, 08270-120
    Brazil

    Site Not Available

  • VielaBio Investigative Site - 2206

    São Paulo, 01228-000
    Brazil

    Site Not Available

  • Viela Bio Investigative Site - 1102

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Viela Bio Investigative Site - 1101

    Montréal, Quebec H2X 3J4
    Canada

    Site Not Available

  • Viela Bio Investigative Site - 1103

    Montréal, Quebec H3A 2B4
    Canada

    Site Not Available

  • Viela Bio Investigative Site - 1104

    West Vancouver, V7T1C5
    Canada

    Site Not Available

  • Viela Bio Investigative Site - 4007

    Beijing, 100053
    China

    Site Not Available

  • Viela Bio Investigative Site 4003

    Beijing, 100070
    China

    Site Not Available

  • Viela Bio Investigative Site 4009

    Beijing, 100029
    China

    Site Not Available

  • Viela Bio Investigative Site - 4005

    Guiyang, 550004
    China

    Site Not Available

  • Viela Bio Investigative site 4010

    Hunan, 410008
    China

    Site Not Available

  • Viela Bio Investigative Site - 4011

    Jinan, 250012
    China

    Site Not Available

  • Viela Bio Investigative Site - 4006

    Shanghai, 201107
    China

    Site Not Available

  • Viela Bio Investigative Site - 4008

    Suzhou, 215006
    China

    Site Not Available

  • Viela Bio Investigative Site - 4004

    Tianjin, 300052
    China

    Site Not Available

  • Viela Bio Investigative Site 4012

    Xi'an, 710038
    China

    Site Not Available

  • Viela Bio Investigative Site - 5602

    Aarhus, 8200
    Denmark

    Site Not Available

  • Viela Bio Investigative Site - 5601

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Viela Bio Investigative Site - 3003

    Lille Cedex, 59037
    France

    Site Not Available

  • Viela Bio Investigative Site - 3001

    Nice Cedex 01, 06001
    France

    Site Not Available

  • Viela Bio Investigative Site - 3002

    Strasbourg, 67098
    France

    Site Not Available

  • VielaBio Investigative Site - 3101

    Essen, 45122
    Germany

    Site Not Available

  • Viela Bio Investigative Site - 4107

    Nagpur, Maharashtra 440003
    India

    Site Not Available

  • Viela Bio Investigative Site - 4113

    Nagpur, Maharashtra 440012
    India

    Site Not Available

  • Viela Bio Investigative Site - 4111

    Vellore, Tamil Nadu 632517
    India

    Site Not Available

  • Viela Bio Investigative Site - 4112

    Hyderabad, Telangana 500082
    India

    Site Not Available

  • Viela Bio Investigative Site - 4104

    Bangalore, 560002
    India

    Site Not Available

  • Viela Bio investigative Site - 4105

    Lucknow, 226014
    India

    Site Not Available

  • Viela Bio Investigative Site - 4103

    Manipal, 576104
    India

    Site Not Available

  • Viela Bio Investigative Site - 4103

    Manipala, 576104
    India

    Site Not Available

  • Viela Bio Investigative Site - 4102

    Nashik, 422002
    India

    Site Not Available

  • Viela Bio Investigative Site - 4110

    Pondicherry, 605 006
    India

    Site Not Available

  • Viela Bio Investigative Site - 4108

    Pune, 411001
    India

    Site Not Available

  • Viela Bio Investigative Site - 4109

    Pune, 411004
    India

    Site Not Available

  • Viela Bio Investigative Site - 4101

    Surat, 395002
    India

    Site Not Available

  • Viela Bio Investigative Site - 5703

    Haifa, 3109601
    Israel

    Site Not Available

  • Viela Bio Investigative Site - 5701

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Viela Bio Investigative Site - 5702

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Viela Bio Investigative Site - 3203

    Milano, 20133
    Italy

    Site Not Available

  • Viela Bio Investigative Site - 3204

    Milano, 20122
    Italy

    Site Not Available

  • Viela Bio Investigative Site - 3201

    Pavia, 27100
    Italy

    Site Not Available

  • Viela Bio Investigative Site - 3202

    Rome, 168
    Italy

    Site Not Available

  • Viela Bio Investigative Site - 4402

    Chiba, 260-8677
    Japan

    Site Not Available

  • Viela Bio Investigative Site - 4410

    Chiba, 286-8520
    Japan

    Site Not Available

  • Viela Bio Investigative Site 4409

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • Viela Bio Investigative Site - 4401

    Hanamaki, 025-0082
    Japan

    Site Not Available

  • VielaBio Investigative Site - 4408

    Hokkaido, 041-8680
    Japan

    Site Not Available

  • Viela Bio Investigative Site - 4406

    Hyōgo, 663-8501
    Japan

    Site Not Available

  • Viela Bio Investigative Site 4405

    Miyagi, 983-8520
    Japan

    Site Not Available

  • Viela Bio Investigative Site - 4413

    Moriguchi, 570-8507
    Japan

    Site Not Available

  • VielaBio Investigative Site - 4407

    Morioka-shi, 020-8505
    Japan

    Site Not Available

  • Viela Bio Investigative Site - 4404

    Saitama, 350-8550
    Japan

    Site Not Available

  • VielaBio Investigative Site - 4411

    Tokyo, 113-8603
    Japan

    Site Not Available

  • Viela Bio Investigative Site - 4201

    Seoul, 6351
    Korea, Republic of

    Site Not Available

  • Viela Bio Investigative Site - 4202

    Seoul, 3722
    Korea, Republic of

    Site Not Available

  • Viela Bio Investigative Site - 4203

    Seoul, 5030
    Korea, Republic of

    Site Not Available

  • Viela Bio Investigative Site - 3302

    Katowice, 40-635
    Poland

    Site Not Available

  • Viela Bio Investigative Site - 3303

    Katowice, 40-752
    Poland

    Site Not Available

  • Viela Bio Investigative Site - 3306

    Katowice, 40-123
    Poland

    Site Not Available

  • Viela Bio Investigative Site - 3301

    Kraków, 31-505
    Poland

    Site Not Available

  • Viela Bio Investigative Site - 3305

    Nowa Sol, 67-100
    Poland

    Site Not Available

  • Med Polonia Sp. z o.o - 3311

    Poznań, 60-693
    Poland

    Site Not Available

  • Viela Bio Investigative Site - 3311

    Poznań, 60-693
    Poland

    Site Not Available

  • Viela Bio Investigative Site - 3310

    Warszawa, 01-868
    Poland

    Site Not Available

  • Viela Bio Investigative Site - 5313

    Barnaul, Altai Krai 656043
    Russian Federation

    Site Not Available

  • Viela Bio Investigative Site - 5303

    Barnaul, 656045
    Russian Federation

    Site Not Available

  • Viela Bio Investigative Site - 5302

    Nizhny Novgorod, 603126
    Russian Federation

    Site Not Available

  • Viela Bio Investigative Site - 5304

    Novosibirsk, 630087
    Russian Federation

    Site Not Available

  • Viela Bio Investigative Site - 5309

    Rostov-on-Don, 344022
    Russian Federation

    Site Not Available

  • Viela Bio Investigative Site - 5311

    Rostov-on-Don, 344015
    Russian Federation

    Site Not Available

  • Viela Bio Investigative Site - 5308

    Saint Petersburg, 197110
    Russian Federation

    Site Not Available

  • Viela Bio Investigative Site - 5305

    Samara, 443095
    Russian Federation

    Site Not Available

  • Viela Bio Investigative Site - 5306

    Smolensk, 214018
    Russian Federation

    Site Not Available

  • Viela Bio Investigative Site - 5301

    Tomsk, 634009
    Russian Federation

    Site Not Available

  • Viela Bio Investigative Site - 5312

    Ufa, 450083
    Russian Federation

    Site Not Available

  • Viela Bio Investigative Site - 3403

    Badalona, 8916
    Spain

    Site Not Available

  • Viela Bio Investigative Site - 3402

    Barcelona, 8003
    Spain

    Site Not Available

  • Viela Bio Investigative Site - 3404

    Córdoba, 14004
    Spain

    Site Not Available

  • Viela Bio Investigative Site - 3401

    Madrid, 28041
    Spain

    Site Not Available

  • Viela Bio Investigative Site - 4601

    Changhua, 500
    Taiwan

    Site Not Available

  • Viela Bio investigative Site - 4605

    Kaohsiung City, 83301
    Taiwan

    Site Not Available

  • Viela Bio Investigative Site 4608

    New Taipei City, 235
    Taiwan

    Site Not Available

  • Viela Bio Investigative Site - 4606

    Tainan, 704
    Taiwan

    Site Not Available

  • Viela Bio Investigative Site - 4603

    Taipei, 111
    Taiwan

    Site Not Available

  • Viela Bio Investigative Site - 4604

    Taipei, 10002
    Taiwan

    Site Not Available

  • Viela Bio Investigative Site -4607

    Taipei, 11217
    Taiwan

    Site Not Available

  • Viela Bio Investigative Site - 4602

    Taoyuan City, 333
    Taiwan

    Site Not Available

  • Viela Bio Investigative Site - 3903

    Ankara, 6230
    Turkey

    Site Not Available

  • Viela Bio Investigative Site - 3901

    Bornova, 35100
    Turkey

    Site Not Available

  • Viela Bio Investigative Site - 3905

    Kocaeli, 41380
    Turkey

    Site Not Available

  • Viela Bio Investigative Site - 3901

    İzmir, 35100
    Turkey

    Site Not Available

  • Viela Bio Investigative Site - 3902

    İzmir, 35330
    Turkey

    Site Not Available

  • Viela Bio Investigative Site - 5103

    Dnipro, 49005
    Ukraine

    Site Not Available

  • Viela Bio Investigative Site - 5108

    Dnipro, 49089
    Ukraine

    Site Not Available

  • Viela Bio Investigative Site - 5105

    Ivano-Frankivs'k, 76493
    Ukraine

    Site Not Available

  • Viela Bio Investigative Site - 5104

    Lutsk, 43005
    Ukraine

    Site Not Available

  • Viela Bio Investigative Site - 5101

    Lviv, 79010
    Ukraine

    Site Not Available

  • Viela Bio Investigative Site - 5106

    Vinnytsia, 21050
    Ukraine

    Site Not Available

  • Viela Bio Investigative Site - 1010

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1015

    Orange, California 92868
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1013

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1002

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Viela Bio Investigative Center - 1024

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1005

    Tampa, Florida 33612
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1016

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1012

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Viela Bio Investigative Site

    Columbia, Maryland 21046
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1011

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1020

    Great Neck, New York 11021
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1007

    New York, New York 10021
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1018

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1025

    Canton, Ohio 44718
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1001

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1009

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1008

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1019

    Austin, Texas 78759
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1003

    Houston, Texas 77030
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1014

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1017

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1004

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Viela Bio Investigative Site - 1006

    Richmond, Virginia 23298
    United States

    Site Not Available

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