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

Last updated: September 26, 2025
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

3

Condition

Collagen Vascular Diseases

Connective Tissue Diseases

Sarcopenia

Treatment

Placebo

IMVT-1402

Clinical Study ID

NCT07039916
IMVT-1402-3101
2024-515979-35-00
  • Ages 18-75
  • All Genders

Study Summary

This is a 26-week study 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 I, II, III, or IV 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: Placebo
Phase: 3
Study Start date:
May 27, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Site Number - 1017

    Phoenix, Arizona 85028
    United States

    Site Not Available

  • Site Number - 1017

    Phoenix 5308655, Arizona 5551752 85028
    United States

    Active - Recruiting

  • Site Number - 1025

    Scottsdale 5313457, Arizona 5551752 85251
    United States

    Active - Recruiting

  • Site Number - 1010

    Carlsbad, California 92011
    United States

    Site Not Available

  • Site Number - 1029

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Site Number - 1004

    San Francisco, California 94143
    United States

    Site Not Available

  • Site Number - 1010

    Carlsbad 5334223, California 5332921 92011
    United States

    Active - Recruiting

  • Site Number - 1029

    Rancho Mirage 5386015, California 5332921 92270
    United States

    Active - Recruiting

  • Site Number - 1004

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • Site Number - 1027

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Site Number - 1027

    Fort Collins 5577147, Colorado 5417618 80528
    United States

    Active - Recruiting

  • Site Number - 1024

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

    Active - Recruiting

  • Site Number - 1006

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Site Number - 1002

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Site Number - 1006

    Clearwater 4151316, Florida 4155751 33761
    United States

    Active - Recruiting

  • Site Number - 1037

    Ormond Beach 4167178, Florida 4155751 32174
    United States

    Active - Recruiting

  • Site Number - 1002

    Port Charlotte 4169130, Florida 4155751 33952
    United States

    Active - Recruiting

  • Site Number - 1014

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Site Number - 1014

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Active - Recruiting

  • Site Number - 1005

    East Lansing, Michigan 48824
    United States

    Site Not Available

  • Site Number - 1005

    East Lansing 4991640, Michigan 5001836 48824
    United States

    Active - Recruiting

  • Site Number - 1019

    Totowa, New Jersey 07503
    United States

    Site Not Available

  • Site Number - 1019

    Totowa 5105455, New Jersey 5101760 07512
    United States

    Active - Recruiting

  • Site Number - 1034

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Site Number - 1020

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Active - Recruiting

  • Site Number - 1013

    Durham 4464368, North Carolina 4482348 27710
    United States

    Active - Recruiting

  • Site Number - 1011

    Yukon, Oklahoma 73099
    United States

    Site Not Available

  • Site Number - 1011

    Yukon 4556165, Oklahoma 4544379 73099
    United States

    Active - Recruiting

  • Site Number - 1031

    Eugene, Oregon 97477
    United States

    Site Not Available

  • Site Number - 1031

    Eugene 5725846, Oregon 5744337 97477
    United States

    Active - Recruiting

  • Site Number - 1015

    Charleston, South Carolina 29486
    United States

    Site Not Available

  • Site Number - 1015

    Charleston 4574324, South Carolina 4597040 29486
    United States

    Active - Recruiting

  • Site Number - 1003

    Dallas, Texas 75206
    United States

    Site Not Available

  • Site Number - 1003

    Dallas 4684888, Texas 4736286 75206
    United States

    Active - Recruiting

  • Site Number - 1009

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Active - Recruiting

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