A Study of IMVT-1402 for Graves' Disease

This study is for adults aged 18 to 75 with Graves' disease (an autoimmune condition causing an overactive thyroid) who are still experiencing hyperthyroidism (overactive thyroid) despite taking antithyroid drugs (ATD). It's testing a drug called IMVT-1402 to see if it's effective, safe, and well-tolerated. Some participants will receive IMVT-1402, while others will receive a placebo (an inactive substance). The main goal is to see how many participants achieve normal thyroid hormone levels (T3, FT4, and TSH) and can stop taking ATD after 26 weeks. The study aims to enroll 240 participants.

Study design
This study is interventional and plans to enroll 240 participants. It compares IMVT-1402 to a placebo.
What's involved
Participants will receive IMVT-1402 or placebo as a subcutaneous (under the skin) injection once a week for either 26 or 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Week 26, and some participants will receive treatment for 52 weeks.

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NCT06727604

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Immunovant Sciences GmbH
~240 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:IMVT-1402Placebo

At a glance

Recruiting sites
124 of 134 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants who are euthyroid (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26
Measured over Week 26
Graves' Disease

NCT06727604

Where you'd take part

This study runs at 134 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Site Number - 1001

    Los Angeles, Californiano site contact published

    Recruiting

  • Site Number - 1002

    Austin, Texasno site contact published

    Recruiting

  • Site Number - 1003

    Portland, Oregonno site contact published

    Recruiting

  • Site Number - 1004

    Mesquite, Texasno site contact published

    Recruiting

  • Site Number - 1005

    Torrance, Californiano site contact published

    Recruiting

  • Site Number - 1007

    Las Vegas, Nevadano site contact published

    Recruiting

  • Site Number - 1008

    Rochester, Minnesotano site contact published

    Recruiting

  • Site Number - 1009

    Round Rock, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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.

Exclusion

Have previously been successfully 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.
  • Percentage of participants who are euthyroid (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26Week 26