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

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

Recruiting
18-75 years
All
Phase 2

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Overview

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

Inclusion Criteria:

  • Participants with the ability to understand the requirements of the trial, provide written 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 Criteria:

  • Have previously been treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
  • Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.
  • Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
  • Additional exclusion criteria are defined in the protocol.

Study details
    Graves' Disease

NCT07018323

Immunovant Sciences GmbH

16 October 2025

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