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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Site Number - 1015
  Tucson, Arizona, United States Recruiting
• Site Number -1014
  Concord, California, United States Recruiting
• Site Number - 1013
  Aurora, Colorado, United States Recruiting
• Site Number - 1024
  Doral, Florida, United States Recruiting
• Site Number - 1008
  Hialeah, Florida, United States Recruiting
• Site Number - 1000
  Miami, Florida, United States Recruiting

+113 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Central Study Contact
• Email: clinicaltrials@immunovant.com
• Phone: 18007970414

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• YB-101 for Graves' Disease: safety, dosing, and how it works

  This study tests YB-101 versus placebo in adults with Graves' disease to see if it is safe, tolerated, and whether it can help thyroid symptoms over about 40 weeks.

  Recruiting at 25 sites Phase 2 Yarrow Bioscience, Inc. · Gilbert, Arizona and 31 other locations · NCT07682896

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.