Assessing IMVT-1402 for treating Graves' disease in adults

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

PHASE2 · Immunovant Sciences GmbH · NCT06727604

This study is testing a new treatment called IMVT-1402 to see if it can help adults with Graves' disease who still have high thyroid levels despite taking other medications.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorImmunovant Sciences GmbH (industry)
Locations133 sites (Phoenix, Arizona and 132 other locations)
Trial IDNCT06727604 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, safety, and tolerability of IMVT-1402 in adult participants diagnosed with Graves' disease who remain hyperthyroid despite treatment with antithyroid drugs. Participants will be assessed for changes in thyroid hormone levels and ATD dosage over a 26-week period. The study compares the effects of IMVT-1402 against a placebo to determine its effectiveness in managing the condition.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with Graves' disease who have been on antithyroid drugs for at least three months and have a TSH level below 0.1 mIU/L.

Not a fit: Patients who have not been on antithyroid drugs or those with TSH levels above 0.1 mIU/L may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Graves' disease who do not respond adequately to current medications.

How similar studies have performed: Other studies have explored treatments for Graves' disease, but the specific approach of using IMVT-1402 is novel and has not been widely tested.

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

Phoenix, Arizona and 132 other locations

+83 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 →

Conditions: Graves' Disease, IMVT-1402, Anti Thyroid Drug, Hyperthyroidism, Autoimmune thyroid disease, Imeroprubart

Last reviewed 2026-05-15 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.