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IMVT-1402 as a treatment for adults with Graves' disease

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease

Phase 2 Interventional Immunovant Sciences GmbH · NCT07018323

This trial tests whether IMVT-1402 can lower thyroid overactivity in adults with Graves' disease who remain hyperthyroid despite antithyroid drugs.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment210 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorImmunovant Sciences GmbH Industry-sponsored
Locations126 sites (Tucson, Arizona and 125 other locations)
Trial IDNCT07018323 on ClinicalTrials.gov

What this trial studies

This is a global, multi-center, randomized, double-blind, placebo-controlled Phase 2b trial comparing IMVT-1402 to placebo in adults with Graves' disease who remain hyperthyroid despite antithyroid drug therapy. Adult participants who meet eligibility will be randomized to receive IMVT-1402 or placebo and followed for measures of thyroid function, safety, and tolerability. The study specifically excludes people who have had successful radioactive iodine therapy or total thyroidectomy and those with certain other autoimmune conditions or severe active thyroid eye disease. Outcomes will include changes in thyroid hormone levels, clinical hyperthyroid symptoms, and adverse events over the treatment period.

Who should consider this trial

Good fit: Adults (≥18 years) with Graves' disease who remain hyperthyroid despite antithyroid drug treatment, who have not had radioactive iodine or total thyroidectomy and who do not have disqualifying autoimmune disease or severe active thyroid eye disease, are the intended participants.

Not a fit: Patients already cured by radioactive iodine or thyroidectomy, those with other autoimmune diseases requiring treatment, or those with moderate-to-severe active thyroid eye disease needing immediate therapy are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, IMVT-1402 could lower pathogenic thyroid-stimulating autoantibodies, improve thyroid hormone control and symptoms, and reduce the need for radioactive iodine or surgery.

How similar studies have performed: Approaches that reduce pathogenic IgG autoantibodies have shown benefit in other antibody-mediated diseases, but this specific agent for Graves' disease is still under clinical investigation and not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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.
* Additional exclusion criteria are defined in the protocol.

Where this trial is running

Tucson, Arizona and 125 other locations

+76 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Graves' DiseaseIMVT-1402Graves' diseaseThyroid-Stimulating Hormone ReceptorImmunoglobulin GAntithyroid drugImeroprubart
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.