Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis

Last updated: March 5, 2026
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

3

Condition

Connective Tissue Diseases

Myasthenia Gravis Generalised

Sarcopenia

Treatment

IMVT-1402

Placebo

Clinical Study ID

NCT07039916
IMVT-1402-3101
2024-515979-35-00
  • Ages 18-80
  • All Genders

Study Summary

The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with the ability to understand the requirements of the trial, providewritten informed consent, and comply with the trial protocol procedures.

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

  • Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visitand Baseline Visit (Day 1)

Additional inclusion criteria are defined in the protocol.

Exclusion

Exclusion Criteria:

  • Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit.

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

  • Have any active or untreated malignant thymoma

Additional exclusion criteria are defined in the protocol.

Study Design

Total Participants: 231
Treatment Group(s): 2
Primary Treatment: IMVT-1402
Phase: 3
Study Start date:
May 27, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Site Number - 3201

    Brno, 60300
    Czechia

    Active - Recruiting

  • Site Number - 3201

    Brno 3078610, 60300
    Czechia

    Site Not Available

  • Site Number - 3601

    Copenhagen, 2177
    Denmark

    Active - Recruiting

  • Site Number - 3601

    Copenhagen 2618425, 2177
    Denmark

    Site Not Available

  • Site Number - 8001

    Tbilisi, 159
    Georgia

    Active - Recruiting

  • Site Number - 8002

    Tbilisi, 0114
    Georgia

    Active - Recruiting

  • Site Number - 8003

    Tbilisi, 114
    Georgia

    Active - Recruiting

  • Site Number - 8001

    Tbilisi 611717, 159
    Georgia

    Active - Recruiting

  • Site Number - 8002

    Tbilisi 611717, 0114
    Georgia

    Active - Recruiting

  • Site Number - 8003

    Tbilisi 611717, 114
    Georgia

    Site Not Available

  • Site Number - 6502

    Bochum, 44791
    Germany

    Active - Recruiting

  • Site Number - 6502

    Bochum 2947416, 44791
    Germany

    Site Not Available

  • Site Number - 6504

    Goettigen, 37075
    Germany

    Active - Recruiting

  • Site Number - 6503

    Würzburg, 97070
    Germany

    Active - Recruiting

  • Site Number - 6503

    Würzburg 2805615, 97070
    Germany

    Site Not Available

  • Site Number - 3902

    Athens, 12462
    Greece

    Active - Recruiting

  • Site Number - 3902

    Athens 264371, 12462
    Greece

    Site Not Available

  • Site Number - 3901

    Pátrai, 26504
    Greece

    Active - Recruiting

  • Site Number - 3901

    Pátrai 255683, 26504
    Greece

    Site Not Available

  • Site Number - 3904

    Thessaloniki, 54642
    Greece

    Active - Recruiting

  • Site Number - 3904

    Thessaloniki 734077, 54642
    Greece

    Site Not Available

  • Site Number - 7552

    Budapest, 1085
    Hungary

    Active - Recruiting

  • Site Number - 7553

    Budapest, 1204
    Hungary

    Active - Recruiting

  • Site Number - 7552

    Budapest 3054643, 1085
    Hungary

    Site Not Available

  • Site Number - 7553

    Budapest 3054643, 1204
    Hungary

    Active - Recruiting

  • Site Number - 7551

    Kistarcsa, 2143
    Hungary

    Active - Recruiting

  • Site Number - 7551

    Kistarcsa 3050290, 2143
    Hungary

    Site Not Available

  • Site Number - 6003

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Site Number - 6003

    Bergamo 3182164, 24127
    Italy

    Site Not Available

  • Site Number - 6002

    Milan, 20133
    Italy

    Active - Recruiting

  • Site Number - 6002

    Milan 3173435, 20133
    Italy

    Site Not Available

  • Site Number - 6001

    Napoli, 80131
    Italy

    Active - Recruiting

  • Site Number - 6001

    Napoli 9031661, 80131
    Italy

    Site Not Available

  • Site Number - 6004

    Rome, 136
    Italy

    Active - Recruiting

  • Site Number - 6004

    Rome 3169070, 136
    Italy

    Site Not Available

  • Site Number - 3001

    Katowice, 40-123
    Poland

    Active - Recruiting

  • Site Number - 3002

    Krakow, 31-503
    Poland

    Active - Recruiting

  • Site Number - 3003

    Krakow, 31-505
    Poland

    Active - Recruiting

  • Site Number - 3006

    Krakow, 31-324
    Poland

    Active - Recruiting

  • Site Number - 3004

    Lublin, 20-701
    Poland

    Active - Recruiting

  • Site Number - 7502

    Constanța, 900348
    Romania

    Active - Recruiting

  • Site Number - 7502

    Constanța 680963, 900348
    Romania

    Site Not Available

  • Site Number - 7501

    Târgu Mureş, 540136
    Romania

    Active - Recruiting

  • Site Number - 7501

    Târgu Mureş 665004, 540136
    Romania

    Site Not Available

  • Site Number - 9001

    Belgrade, 11000
    Serbia

    Active - Recruiting

  • Site Number - 9001

    Belgrade 792680, 11000
    Serbia

    Site Not Available

  • Site Number - 9002

    Niš, 18000
    Serbia

    Active - Recruiting

  • Site Number - 9002

    Niš 787657, 18000
    Serbia

    Site Not Available

  • Site Number - 7103

    Barcelona, 8195
    Spain

    Active - Recruiting

  • Site Number - 7103

    Barcelona 3128760, 8195
    Spain

    Site Not Available

  • Site Number - 7101

    Córdoba, 14011
    Spain

    Active - Recruiting

  • Site Number - 7101

    Córdoba 2519240, 14011
    Spain

    Site Not Available

  • Site Number - 7104

    Madrid, 28034
    Spain

    Active - Recruiting

  • Site Number - 7104

    Madrid 3117735, 28034
    Spain

    Site Not Available

  • Site Number - 7002

    Glasgow, G51 4TF
    United Kingdom

    Active - Recruiting

  • Site Number - 7002

    Glasgow 2648579, G51 4TF
    United Kingdom

    Site Not Available

  • Site Number - 1041

    Mobile, Alabama 36604
    United States

    Active - Recruiting

  • Site Number - 1041

    Mobile 4076598, Alabama 4829764 36604
    United States

    Site Not Available

  • Site Number - 1017

    Phoenix, Arizona 85028
    United States

    Active - Recruiting

  • Site Number - 1025

    Scottsdale, Arizona 85251
    United States

    Active - Recruiting

  • Site Number - 1042

    Tucson, Arizona 85718
    United States

    Active - Recruiting

  • Site Number - 1017

    Phoenix 5308655, Arizona 5551752 85028
    United States

    Site Not Available

  • Site Number - 1025

    Scottsdale 5313457, Arizona 5551752 85251
    United States

    Site Not Available

  • Site Number - 1042

    Tucson 5318313, Arizona 5551752 85718
    United States

    Site Not Available

  • Site Number - 1010

    Carlsbad, California 92011
    United States

    Active - Recruiting

  • Site Number - 1028

    Irvine, California 92697
    United States

    Active - Recruiting

  • Site Number - 1023

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Site Number - 1029

    Rancho Mirage, California 92270
    United States

    Active - Recruiting

  • Site Number - 1004

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Site Number - 1010

    Carlsbad 5334223, California 5332921 92011
    United States

    Site Not Available

  • Site Number - 1028

    Irvine 5359777, California 5332921 92697
    United States

    Site Not Available

  • Site Number - 1023

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • Site Number - 1029

    Rancho Mirage 5386015, California 5332921 92270
    United States

    Site Not Available

  • Site Number - 1004

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • Site Number - 1027

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Site Number - 1027

    Fort Collins 5577147, Colorado 5417618 80528
    United States

    Site Not Available

  • Site Number - 1001

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Site Number - 1001

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Site Number - 1024

    Washington D.C., District of Columbia 20010
    United States

    Active - Recruiting

  • Site Number - 1024

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Site Not Available

  • Site Number - 1006

    Clearwater, Florida 33761
    United States

    Active - Recruiting

  • Site Number - 1037

    Ormond Beach, Florida 32174
    United States

    Active - Recruiting

  • Site Number - 1002

    Port Charlotte, Florida 33952
    United States

    Active - Recruiting

  • Site Number - 1050

    Rockledge, Florida 32955
    United States

    Active - Recruiting

  • Site Number - 1007

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Site Number - 1006

    Clearwater 4151316, Florida 4155751 33761
    United States

    Site Not Available

  • Site Number - 1037

    Ormond Beach 4167178, Florida 4155751 32174
    United States

    Site Not Available

  • Site Number - 1002

    Port Charlotte 4169130, Florida 4155751 33952
    United States

    Site Not Available

  • Site Number - 1050

    Rockledge 4170358, Florida 4155751 32955
    United States

    Site Not Available

  • Site Number - 1007

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Site Number - 1014

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

  • Site Number - 1043

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Site Number - 1014

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Site Not Available

  • Site Number - 1043

    Augusta 4180531, Georgia 4197000 30912
    United States

    Site Not Available

  • Site Number - 1022

    Lexington, Kentucky 40536-0284
    United States

    Active - Recruiting

  • Site Number - 1032

    Nicholasville, Kentucky 40356
    United States

    Active - Recruiting

  • Site Number - 1022

    Lexington 4297983, Kentucky 6254925 40536-0284
    United States

    Site Not Available

  • Site Number - 1032

    Nicholasville 4302561, Kentucky 6254925 40356
    United States

    Site Not Available

  • Site Number - 1046

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • Site Number - 1046

    New Orleans 4335045, Louisiana 4331987 70121
    United States

    Site Not Available

  • Site Number - 1049

    Foxborough, Massachusetts 02035
    United States

    Active - Recruiting

  • Site Number - 1049

    Foxborough 4937222, Massachusetts 6254926 02035
    United States

    Site Not Available

  • Site Number - 1026

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Site Number - 1005

    East Lansing, Michigan 48824
    United States

    Active - Recruiting

  • Site Number - 1026

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Site Number - 1005

    East Lansing 4991640, Michigan 5001836 48824
    United States

    Site Not Available

  • Site Number - 1018

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Site Number - 1018

    Omaha 5074472, Nebraska 5073708 68198
    United States

    Site Not Available

  • Site Number - 1019

    Totowa, New Jersey 07512
    United States

    Active - Recruiting

  • Site Number - 1019

    Totowa 5105455, New Jersey 5101760 07512
    United States

    Site Not Available

  • Site Number - 1034

    New York, New York 10065
    United States

    Active - Recruiting

  • Site Number - 1036

    New York, New York 10021
    United States

    Active - Recruiting

  • Site Number - 1034

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Site Number - 1036

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • Site Number - 1020

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Site Number - 1013

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Site Number - 1044

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Site Number - 1020

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • Site Number - 1013

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Site Number - 1044

    Raleigh 4487042, North Carolina 4482348 27607
    United States

    Site Not Available

  • Site Number - 1038

    Cincinnati, Ohio 45221
    United States

    Active - Recruiting

  • Site Number - 1038

    Cincinnati 4508722, Ohio 5165418 45221
    United States

    Site Not Available

  • Site Number - 1011

    Yukon, Oklahoma 73099
    United States

    Active - Recruiting

  • Site Number - 1011

    Yukon 4556165, Oklahoma 4544379 73099
    United States

    Site Not Available

  • Site Number - 1031

    Eugene, Oregon 97477
    United States

    Active - Recruiting

  • Site Number - 1031

    Eugene 5725846, Oregon 5744337 97477
    United States

    Site Not Available

  • Site Number - 1015

    Charleston, South Carolina 29486
    United States

    Active - Recruiting

  • Site Number - 1030

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Site Number - 1015

    Charleston 4574324, South Carolina 4597040 29486
    United States

    Active - Recruiting

  • Site Number - 1030

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Site Number - 1021

    Memphis, Tennessee 38120
    United States

    Active - Recruiting

  • Site Number - 1021

    Memphis 4641239, Tennessee 4662168 38120
    United States

    Site Not Available

  • Site Number - 1003

    Dallas, Texas 75206
    United States

    Active - Recruiting

  • Site Number - 1047

    Denton, Texas 76208
    United States

    Active - Recruiting

  • Site Number - 1048

    Lubbock, Texas 79414
    United States

    Active - Recruiting

  • Site Number - 1003

    Dallas 4684888, Texas 4736286 75206
    United States

    Site Not Available

  • Site Number - 1047

    Denton 4685907, Texas 4736286 76208
    United States

    Site Not Available

  • Site Number - 1048

    Lubbock 5525577, Texas 4736286 79414
    United States

    Site Not Available

  • Site Number - 1009

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Site Number - 1040

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Site Number - 1009

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

  • Site Number - 1040

    Richmond 4781708, Virginia 6254928 23298
    United States

    Site Not Available

  • Site Number - 1035

    Greenfield, Wisconsin 53228
    United States

    Active - Recruiting

  • Site Number - 1035

    Greenfield 5255068, Wisconsin 5279468 53228
    United States

    Site Not Available

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