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

Last updated: April 10, 2025
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Thyroid Disease

Thyroid Disorders

Treatment

Placebo

IMVT-1402

Clinical Study ID

NCT06727604
IMVT-1402-2502
2024-516020-33-00
  • Ages 18-75
  • All Genders

Study Summary

This is a 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.

The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine [T3] or free triiodothyronine [FT3]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have documented diagnosis of GD.

  • Have a TSH value < 0.1 mIU/L as assessed by the local laboratory at the ScreeningVisit.

  • Meet one of the following at the Screening Visit:

  • Have been on ATD for ≥ 3 months in the period immediately preceding theScreening Visit and both of the following:

  • Are on ATD at the Screening Visit with an ATD dose a specified amount ofmethimazole or equivalent for the 4-week period immediately preceding theScreening Visit.

  • Are anticipated to be on a stable dose of ATD for the 4-week periodimmediately preceding Randomization.

  • Have been on ATD for ≥ 6 months in the period immediately preceding theScreening Visit and all of the following:

  • Have been treated with ≥ 15 mg/day methimazole or equivalent at any pointduring the participant's treatment history.

  • Are on ATD at the Screening Visit with an ATD dose a specified amount ofmethimazole or equivalent for the 4-week period immediately preceding theScreening Visit.

  • Are anticipated to be on a stable dose of ATD for the 4-week periodimmediately preceding Randomization.

Additional inclusion criteria are defined in the protocol.

Exclusion

Exclusion Criteria:

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

  • Have a T3 (Total T3 or FT3, as available and per standard of care at locallaboratory) or FT4 value < lower limit of normal (LLN) as assessed by the locallaboratory at the Screening Visit.

  • Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6weeks of the Screening Visit.

  • Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxicmultinodular goiter) and/or history of thyroid storm within 6 months of theScreening Visit.

  • 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: 240
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 17, 2024
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Site Number - 1006

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Site Number - 1013

    Englewood, Colorado 80113
    United States

    Active - Recruiting

  • Site Number - 1011

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • Site Number - 1016

    Port Charlotte, Florida 33952
    United States

    Active - Recruiting

  • Site Number - 1012

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • Site Number - 1018

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Site Number - 1007

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

  • Site Number - 1003

    Portland, Oregon 97035
    United States

    Active - Recruiting

  • Site Number - 1015

    Summerville, South Carolina 29485
    United States

    Active - Recruiting

  • Site Number - 1002

    Austin, Texas 78731
    United States

    Active - Recruiting

  • Site Number - 1019

    Dallas, Texas 75208
    United States

    Active - Recruiting

  • Site Number - 1031

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Site Number - 1004

    Mesquite, Texas 75149
    United States

    Active - Recruiting

  • Site Number - 1009

    Round Rock, Texas 78681
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.