Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

Last updated: August 6, 2024
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Not Recruiting

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Neuropathy

Myasthenia Gravis Generalised

Treatment

Matching Placebo SC

Batoclimab 340 mg SC weekly

Batoclimab 680 mg SC weekly

Clinical Study ID

NCT05403541
IMVT-1401-3101
  • Ages > 18
  • All Genders

Study Summary

The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3). Participants who complete Period 3 are eligible to participate in Period 4 (Optional Long-Term extension) according to their treatment assignment in Period 3.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Are ≥ 18 years of age at the Screening Visit.

  2. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA)classification Class II, III, or IVa at the Screening Visit.

  3. Have a QMG score ≥ 11 at the Screening and Baseline Visits.

  4. Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.

  5. Additional inclusion criteria are defined in the protocol.

Exclusion

Exclusion Criteria:

  1. Have experienced myasthenic crisis within 3 months of the Screening Visit.

  2. Have had a thymectomy performed < 6 months prior to the Screening Visit or have aplanned thymectomy during the study period.

  3. Have any active or untreated malignant thymoma.

  4. Have received any agent or therapy (exclusive of those identified within inclusioncriteria) with immunosuppressive properties (e.g., stem cell therapy,chemotherapies) within the past year.

  5. Have used anti-FcRn treatment within 3 months prior to the Screening Visit or have adocumented history of non-response to prior anti-FcRn treatment.

  6. Additional exclusion criteria are defined in the protocol.

Study Design

Total Participants: 240
Treatment Group(s): 4
Primary Treatment: Matching Placebo SC
Phase: 3
Study Start date:
June 27, 2022
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • Site Number - 5001

    Buenos Aires, C1428AQK
    Argentina

    Site Not Available

  • Site Number - 5002

    Buenos Aires, 4190
    Argentina

    Site Not Available

  • Site Number - 5003

    Rosario, S2000
    Argentina

    Site Not Available

  • Site Number - 5501

    Ribeirão Preto, 14051-140
    Brazil

    Site Not Available

  • Site Number- 5503

    Rio De Janeiro, 22640-100
    Brazil

    Site Not Available

  • Site Number -2001

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Site Number - 2003

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Site Number - 2002

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Site Number - 2004

    Montreal, Quebec H3A 2B4
    Canada

    Site Not Available

  • Site Number -2004

    Montreal, Quebec H3A 2B4
    Canada

    Active - Recruiting

  • Site Number - 8005

    Tbilisi, 0179
    Georgia

    Site Not Available

  • Site Number -8001

    Tbilisi, 00160
    Georgia

    Site Not Available

  • Site Number -8002

    Tbilisi, 00114
    Georgia

    Site Not Available

  • Site Number -8003

    Tbilisi, 00186
    Georgia

    Site Not Available

  • Site Number -8004

    Tbilisi, 00114
    Georgia

    Site Not Available

  • Site Number - 6507

    Berlin, 10117
    Germany

    Site Not Available

  • Site Number - 6506

    Bochum, 44791
    Germany

    Site Not Available

  • Site Number - 6501

    Hamburg, 20246
    Germany

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  • Site Number - 6503

    Jena, 7747
    Germany

    Site Not Available

  • Site Number -6504

    Leipzig, 04103
    Germany

    Site Not Available

  • Site Number -6502

    Würzburg, 97074
    Germany

    Site Not Available

  • Site Number -7553

    Budapest, 1082
    Hungary

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  • Site Number - 7552

    Kistarcsa, 2143
    Hungary

    Site Not Available

  • Site Number - 6004

    Bergamo, 24127
    Italy

    Site Not Available

  • Site Number -6006

    Brescia, 25123
    Italy

    Site Not Available

  • Site Number - 6002

    Genova, 16132
    Italy

    Site Not Available

  • Site Number - 6003

    Milano, 20133
    Italy

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  • Site Number - 6007

    Napoli, 80131
    Italy

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  • Site Number -6001

    Napoli, 80131
    Italy

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  • Site Number -6005

    Roma, 00189
    Italy

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  • Site Number - 4020

    Asahikawa-shi, 078-8510
    Japan

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  • Site Number - 4014

    Fuchu-shi, 183-0042
    Japan

    Site Not Available

  • Site Number -4014

    Fuchu-shi, 183-0042
    Japan

    Active - Recruiting

  • Site Number - 4002

    Hanamaki-shi, 025-0082
    Japan

    Site Not Available

  • Site Number - 4013

    Higashimatsushima, 355-0005
    Japan

    Site Not Available

  • Site Number - 4006

    Kagawa, 761-0793
    Japan

    Site Not Available

  • Site Number - 4009

    Kawasaki-shi, 216-8511
    Japan

    Site Not Available

  • Site Number - 4012

    Koriyama-shi, 963-8563
    Japan

    Site Not Available

  • Site Number - 4007

    Koshigaya-shi, 343-8555
    Japan

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  • Site Number - 4011

    Matsuyama-shi, 791-8026
    Japan

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  • Site Number - 4008

    Miyagi, 983-8520
    Japan

    Site Not Available

  • Site Number - 4003

    Narita-shi, 286-8520
    Japan

    Site Not Available

  • Site Number - 4001

    Osaka, 589-8511
    Japan

    Site Not Available

  • Site Number - 4004

    Osaka, 565-0871
    Japan

    Site Not Available

  • Site Number - 4010

    Osaka, 534-0021
    Japan

    Site Not Available

  • Site Number - 4005

    Tokyo, 160-0023
    Japan

    Site Not Available

  • Site Number - 4018

    Toyama-shi, 930-0194
    Japan

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  • Site Number - 4015

    Yokohama, 236-0004
    Japan

    Site Not Available

  • Site Number - 4016

    Yokohama-shi, 222-0036
    Japan

    Site Not Available

  • Site Number - 4019

    Yokohama-shi, 230-8765
    Japan

    Site Not Available

  • Site Number -4016

    Yokohama-shi, 222-0036
    Japan

    Active - Recruiting

  • Site Number - 4017

    Yonago-shi, 683-8504
    Japan

    Site Not Available

  • Site Number -4017

    Yonago-shi, 683-8504
    Japan

    Active - Recruiting

  • Site Number -4505

    Daegu, 41944
    Korea, Republic of

    Site Not Available

  • Site Number -4501

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Site Number - 2601

    Mexico City, 06700
    Mexico

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  • Site Number - 3007

    Gdańsk, 80-214
    Poland

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  • Site Number -3001

    Katowice, 40-123
    Poland

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  • Site Number - 3003

    Krakow, 31-503
    Poland

    Site Not Available

  • Site Number -3004

    Krakow, 31-324
    Poland

    Site Not Available

  • Site Number -3002

    Kraków, 31-505
    Poland

    Site Not Available

  • Site Number - 3008

    Lublin, 20-701
    Poland

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  • Site Number -3006

    Poznań, 61-731
    Poland

    Site Not Available

  • Site Number - 3005

    Warszawa, 01-684
    Poland

    Site Not Available

  • Site Number -7502

    Constanta, 900628
    Romania

    Site Not Available

  • Site Number -7501

    Targu Mures, 540136
    Romania

    Site Not Available

  • Site Number -7503

    Timişoara, 300723
    Romania

    Site Not Available

  • Site Number - 9001

    Belgrade, 11000
    Serbia

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  • Site Number - 9002

    Niš, 1800
    Serbia

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  • Site Number -3502

    Barcelona, 08195
    Spain

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  • Site Number -3505

    Barcelona, 8041
    Spain

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  • Site Number -3504

    Cordoba, 14011
    Spain

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  • Site Number -3501

    Madrid, 028034
    Spain

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  • Site Number -3503

    Madrid, 28046
    Spain

    Site Not Available

  • Site Number - 7001

    Liverpool, L9 7LJ
    United Kingdom

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  • Site Number - 7002

    Sheffield, S102JF
    United Kingdom

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  • Site Number -1022

    Phoenix, Arizona 85028
    United States

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  • Site Number -1029

    Scottsdale, Arizona 85251
    United States

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  • Site Number -1002

    Carlsbad, California 92011
    United States

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  • Site Number -1009

    Irvine, California 92697
    United States

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  • Site Number - 1012

    Olive View, California 91342
    United States

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  • Site Number -1032

    San Francisco, California 94143
    United States

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  • Site Number - 1027

    Aurora, Colorado 80045
    United States

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  • Site Number - 1025

    New Haven, Connecticut 06519
    United States

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  • Site Number -1017

    Boca Raton, Florida 33487
    United States

    Site Not Available

  • Site Number -1007

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Site Number -1010

    Maitland, Florida 32751
    United States

    Site Not Available

  • Site Number - 1020

    Miami, Florida 33136
    United States

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  • Site Number -1019

    Orlando, Florida 32806
    United States

    Site Not Available

  • Site Number - 1028

    Port Charlotte, Florida 33952
    United States

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  • Site Number - 1015

    Tampa, Florida 33612
    United States

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  • Site Number -1011

    Fairway, Kansas 66205
    United States

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  • Site Number -1003

    Lexington, Kentucky 40536
    United States

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  • Site Number -1013

    East Lansing, Michigan 48824
    United States

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  • Site Number - 1024

    Minneapolis, Minnesota 55414
    United States

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  • Site Number - 1021

    Buffalo, New York 14203
    United States

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  • Site Number - 1018

    Chapel Hill, North Carolina 27599
    United States

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  • Site Number - 1008

    Durham, North Carolina 27710
    United States

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  • Site Number -1004

    Cleveland, Ohio 44195
    United States

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  • Site Number -1006

    Portland, Oregon 97239
    United States

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  • Site Number - 1023

    Philadelphia, Pennsylvania 19104
    United States

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  • Site Number - 1030

    Charleston, South Carolina 29425
    United States

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  • Site Number - 1026

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Site Number -1001

    Austin, Texas 78759
    United States

    Site Not Available

  • Site Number -1016

    Dallas, Texas 75206
    United States

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  • Site Number - 1034

    Houston, Texas 77030
    United States

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  • Site Number - 1014

    Round Rock, Texas 78681
    United States

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  • Site Number -1031

    Murray, Utah 84107
    United States

    Site Not Available

  • Site Number -1005

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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