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Study of IMVT-1402 Treatment for Adults with Graves' Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Graves' Disease, which is an autoimmune condition that causes the thyroid gland to produce too much thyroid hormone. The research evaluates a new medication called IMVT-1402, which is given as an injection under the skin.

The purpose of this research is to determine how well IMVT-1402 works compared to placebo in treating adults with Graves' Disease. The study examines the medication's effects on thyroid hormone levels and the need for standard thyroid medications over a 26-week period.

During the study, participants will receive either IMVT-1402 injections or placebo. The medication will be given as a subcutaneous injection, which means it is administered under the skin. The maximum daily dose of the study medication can be up to 600 milligrams. The study will monitor how the treatment affects thyroid hormone levels and overall thyroid function throughout the treatment period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and trial start

    You will be diagnosed with Graves' Disease and currently receiving ATD (Anti-Thyroid Drug) treatment

    Your thyroid hormone levels will be checked to confirm they are above normal despite ATD treatment

    You must be 18 years or older to participate

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either IMVT-1402 or a placebo

    The treatment will be given as an injection under the skin (subcutaneous injection)

    Neither you nor your doctor will know which treatment you are receiving

  3. Step 3

    Early monitoring phase

    Your thyroid hormone levels (T3, T4, and TSH) will be checked at week 2

    Another check of thyroid hormone levels will be performed at week 4

    These tests will determine how your body is responding to the treatment

  4. Step 4

    Main treatment period

    The treatment will continue for a total of 26 weeks

    Regular monitoring of your thyroid function will occur throughout this period

    Your ATD dose may be adjusted based on your response to treatment

  5. Step 5

    Final evaluation

    At week 26, final assessments will be performed to check:

    Whether your thyroid hormone levels have returned to normal range

    If you are able to stop taking ATD medication

    The presence of thyroid antibodies in your blood

Who can join the trial?

5 criteria

  • Must be able to understand the trial requirements and agree to participate by providing written informed consent
  • Must be 18 years of age or older
  • Must have a diagnosis of Graves' Disease with symptoms of overactive thyroid (hyperthyroid) despite being on anti-thyroid drug treatment (medications that reduce thyroid hormone production)
  • Must be willing and able to follow all study procedures and requirements
  • Can be either male or female

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Pregnant or breastfeeding women
  • History of thyroid cancer or suspected thyroid cancer
  • Severe liver problems (as indicated by liver function tests more than 3 times the normal range)
  • Severe kidney disease (requiring dialysis or with severely reduced kidney function)
  • Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
  • Major surgery within 3 months before the start of the study
  • Current participation in other clinical trials
  • History of allergic reactions to similar medications
  • Significant heart problems, including heart failure or recent heart attack
  • Untreated or unstable mental health conditions
  • Active infections that require treatment
  • Use of medications that could interfere with thyroid function tests
  • Alcohol or drug abuse within the past year
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

  • IMVT-1402

    is an investigational medication being studied for the treatment of Graves' Disease, an autoimmune disorder that affects the thyroid gland. This medication is designed to help regulate thyroid hormone levels in adult patients. It works by targeting the immune system's response that causes the thyroid to produce excess hormones in Graves' Disease.

  • Anti-thyroid drugs (ATDs)

    are standard medications used to treat Graves' Disease. These medications help reduce the production of thyroid hormones. In this study, they are used alongside the investigational treatment to monitor how well IMVT-1402 works in helping patients potentially reduce their need for standard thyroid medications.

What is already known about the treatment

IMVT-1402 – An investigational medication being studied in clinical trials for the treatment of Graves' Disease, administered through subcutaneous injection. This novel therapeutic agent belongs to the class of immunological medications and is currently undergoing Phase 2b clinical trials to evaluate its efficacy, safety, and tolerability in adult patients. The medication works by targeting and modifying the immune response that causes thyroid overactivity in Graves' Disease, potentially affecting thyroid hormone levels (T3, T4) and thyroid-stimulating hormone (TSH). IMVT-1402 is being tested against placebo to determine its effectiveness in managing thyroid function and reducing the need for conventional anti-thyroid drugs (ATDs).

Investigated diseases

Graves' Disease - An autoimmune disorder that affects the thyroid gland, causing it to produce excessive amounts of thyroid hormones. The condition typically develops gradually and leads to an overactive thyroid state known as hyperthyroidism. The immune system creates antibodies that stimulate the thyroid gland to grow and produce more thyroid hormones than the body needs. Common manifestations include enlargement of the thyroid gland, changes in energy levels, and alterations in metabolism. The condition can also affect the eyes, causing them to become irritated or protruding.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521920-31-00Protocol codeIMVT-1402-2503Estimated enrolment218 patientsSponsorImmunovant Sciences GmbH

sourced from the EU Clinical Trials Register and site verification

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