A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

Last updated: August 14, 2025
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Thyroid Disease

Thyroid Disorders

Treatment

Placebo

IMVT-1402

Clinical Study ID

NCT07018323
IMVT-1402-2503
2025-521920-31-00
  • Ages 18-75
  • All Genders

Study Summary

This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.

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.

  • Male or female participants aged ≥ 18 years.

  • Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.

  • Other, more specific inclusion criteria are defined in the protocol.

Exclusion

Exclusion Criteria:

  • Have previously been treated with radioactive iodine (RAI) therapy or have undergonetotal thyroidectomy.

  • Have an autoimmune disease other than GD requiring treatment that, in theInvestigator's judgment, puts the participant at undue risk.

  • Have moderate-to-severe active thyroid eye disease (TED) and are expected to requireimmediate surgical intervention and/or are planning corrective surgery/irradiationor medical therapy for TED during study participation.

  • Additional exclusion criteria are defined in the protocol.

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 19, 2025
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Site Number - 1008

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Site Number - 1000

    Miami, Florida 33143
    United States

    Active - Recruiting

  • Site Number - 1020

    Columbus, Georgia 31904
    United States

    Active - Recruiting

  • Site Number - 1001

    Morehead City, North Carolina 27577
    United States

    Active - Recruiting

  • Site Number - 1002

    El Paso, Texas 79935
    United States

    Active - Recruiting

  • Site Number - 1003

    Fort Worth, Texas 76132
    United States

    Active - Recruiting

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