Recruiting
Phase 3

IMVT-1402

Sponsor:

Immunovant Sciences GmbH

Code:

NCT07039916

Conditions

Generalized Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

IMVT-1402

IMVT-1402

Placebo

IMVT-1402

Study Details

Brief 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.

Conditions

Generalized Myasthenia Gravis

Study ID

NCT07039916

Start date

May 27, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants with the ability to understand the requirements of the trial, provide written 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 Visit and Baseline Visit (Day 1)

Additional inclusion criteria are defined in the protocol.

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 a planned thymectomy during the study
  • Have any active or untreated malignant thymoma

Additional exclusion criteria are defined in the protocol.

Study Design

Enrollment

231 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: IMVT-1402 Dose 1

experimental: Group 2: IMVT-1402 Dose 2

placebo comparator: Placebo/ IMVT-1402

Interventions

IMVT-1402

• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)

IMVT-1402

  • Dose 2 SC QW for 12 weeks (Period 1)
  • Dose 2 SC QW for 14 weeks (Period 2)
  • Dose 2 SC QW for 52 weeks (Period 3)

Placebo

• Placebo SC QW for 12 weeks (Period 1)

IMVT-1402

  • Dose 1 SC QW for 14 weeks (Period 2)
  • Dose 1 SC QW for 52 weeks (Period 3)

Primary outcome measure

  • Change from Baseline in MG-ADL Score for Antibody-positive Participants [ Time Frame: Baseline to Week 12 ]

Central Contacts and Locations

Central contacts

Central Study Contact

18007970414clinicaltrials@immunovant.com

Locations

Site Number - 1056

Recruiting

Huntsville, Alabama, United States, 35801

Site Number - 1041

Recruiting

Mobile, Alabama, United States, 36604

Site Number - 1017

Recruiting

Phoenix, Arizona, United States, 85028

Site Number - 1025

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Scottsdale, Arizona, United States, 85251

Site Number - 1042

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Tucson, Arizona, United States, 85718

Site Number - 1010

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Carlsbad, California, United States, 92011

Site Number - 1028

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Irvine, California, United States, 92697

Site Number - 1023

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Los Angeles, California, United States, 90033

Site Number - 1029

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Rancho Mirage, California, United States, 92270

Site Number - 1004

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San Francisco, California, United States, 94143

Site Number - 1027

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Fort Collins, Colorado, United States, 80528

Site Number - 1001

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New Haven, Connecticut, United States, 06510

Site Number - 1024

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

Site Number - 1006

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Clearwater, Florida, United States, 33761

Site Number - 1037

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Ormond Beach, Florida, United States, 32174

Site Number - 1002

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Port Charlotte, Florida, United States, 33952

Site Number - 1050

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Rockledge, Florida, United States, 32955

Site Number - 1007

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Tampa, Florida, United States, 33612

Site Number - 1014

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Atlanta, Georgia, United States, 30329

Site Number - 1043

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Augusta, Georgia, United States, 30912

Site Number - 1054

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Schaumburg, Illinois, United States, 60173

Site Number - 1022

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Lexington, Kentucky, United States, 40536-0284

Site Number - 1032

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Nicholasville, Kentucky, United States, 40356

Site Number - 1046

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New Orleans, Louisiana, United States, 70121

Site Number - 1049

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Foxborough, Massachusetts, United States, 02035

Site Number - 1026

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Detroit, Michigan, United States, 48201

Site Number - 1005

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East Lansing, Michigan, United States, 48824

Site Number - 1018

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Omaha, Nebraska, United States, 68198

Site Number - 1019

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Totowa, New Jersey, United States, 07512

Site Number - 1036

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New York, New York, United States, 10021

Site Number - 1034

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New York, New York, United States, 10065

Site Number - 1020

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Chapel Hill, North Carolina, United States, 27599

Site Number - 1013

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Durham, North Carolina, United States, 27710

Site Number - 1044

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Raleigh, North Carolina, United States, 27607

Site Number - 1038

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Cincinnati, Ohio, United States, 45221

Site Number - 1045

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Oklahoma City, Oklahoma, United States, 73104

Site Number - 1011

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Yukon, Oklahoma, United States, 73099

Site Number - 1031

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Eugene, Oregon, United States, 97477

Site Number - 1030

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Charleston, South Carolina, United States, 29425

Site Number - 1015

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Charleston, South Carolina, United States, 29486

Site Number - 1021

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Memphis, Tennessee, United States, 38120

Site Number - 1003

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Dallas, Texas, United States, 75206

Site Number - 1047

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Denton, Texas, United States, 76208

Site Number - 1057

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Houston, Texas, United States, 77054

Site Number - 1048

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Lubbock, Texas, United States, 79414

Site Number - 1009

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Charlottesville, Virginia, United States, 22903

Site Number - 1040

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Richmond, Virginia, United States, 23298

Site Number - 1035

Recruiting

Greenfield, Wisconsin, United States, 53228

More Information

Sponsor

Immunovant Sciences GmbH

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • IMVT-1402
  • Generalized Myasthenia Gravis
  • Acetylcholine receptor
  • Muscle-specific kinase
  • Autoantibody
  • Lipoprotein receptor-related protein 4
  • Autoimmune disease
  • Neonatal fragment crystallizable receptor (FcRn)
  • Imeroprubart

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Immunovant Sciences GmbH on 2026-07-30.