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Long-Term Study of Imeroprubart in Adults With Graves' Disease

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study is being done in adults with Graves’ Disease, a condition in which the immune system makes the thyroid gland work too hard. The treatment being studied is IMVT-1402 (imeroprubart), given as a subcutaneous injection, which means an injection under the skin. The purpose of the study is to see how well this treatment works over time and whether it is safe and well tolerated.

The study follows people for a long period and looks at whether normal thyroid function can be kept after treatment has been stopped. During the study, adults receive the study medicine and are then observed over time to see whether thyroid levels remain stable without ATD (anti-thyroid drugs, medicines that lower thyroid hormone). Some participants may stop the study medicine earlier or later than others as part of the study plan. The study also checks whether TRAb (thyroid-stimulating hormone receptor antibodies, proteins made by the immune system that can affect the thyroid) are no longer found in the blood.

The study is designed as a long-term extension, meaning it continues to follow people who have already taken part in earlier research with this medicine. Information is collected over many months, with the main follow-up lasting up to 52 weeks after treatment changes. The study uses groups of participants to compare how long thyroid control lasts after stopping treatment and how often the disease returns, also called a relapse.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Trial entry and group assignment

    At the start of the study, you join a long-term extension study for adults with Graves' disease.

    Your study group may be group a, group b, or group c. The study follows each group over time and compares whether thyroid function stays normal after treatment changes.

  2. Step 2

    Study treatment with imvt-1402

    You receive imvt-1402, which contains imeroprubart, as a subcutaneous injection (an injection under the skin).

    The dose is 600 mg per dose. The source data do not state how often the dose is given or how long it is continued for each person.

  3. Step 3

    Thyroid medicine is stopped when required by the study

    The study measures whether you stay euthyroid, which means your thyroid levels stay in the normal range.

    The study also checks whether you remain off atd, which means you are not taking antithyroid drugs (medicines used to lower thyroid activity).

  4. Step 4

    Follow-up through week 26

    By week 26, the study checks whether you are still euthyroid and off atd.

    For group a, the study also checks whether you are seronegative for trab, which means a blood test for trab (thyrotropin receptor antibodies, antibodies linked to Graves' disease) is negative.

  5. Step 5

    Follow-up through week 52

    By week 52, the study checks whether you remain euthyroid, off atd, and off imvt-1402.

    The study also looks for the earliest date of a confirmed relapse, which means the return of disease signs or abnormal thyroid levels after improvement.

  6. Step 6

    Long-term observation during the study period

    The study continues to follow the effect and safety of imvt-1402 for up to 52 weeks after the start of this extension study for each participant.

    The overall study is planned to run from the estimated start date of 2026-05-15 to the estimated end date of 2030-03-30.

Who can join the trial?

1 criterion

  • Participants must have completed Study IMVT-1402-2502 or Study IMVT-1402-2503.

Who cannot join the trial?

2 criteria

  • They cannot take part if they permanently stopped the study medicine during the treatment period in the earlier study. This means they stopped the investigational medicine and did not restart it.
  • They cannot take part if they met the study stopping criteria at any time before the earlier study ended. Study stopping criteria are the specific medical or safety rules that require a participant to stop being in the study.
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Investigated drugs

IMVT-1402 is the study medicine being tested in this trial. It is given as a shot under the skin. The trial is looking at whether it can help people with Graves' disease keep normal thyroid levels without needing anti-thyroid medicine and without continuing IMVT-1402. Researchers are also checking how safe it is and how well patients tolerate it over time.

What is already known about the treatment

Imeroprubart - Imeroprubart is given as a solution for injection under the skin, usually by subcutaneous use, in this study. It is an investigational medicine, meaning it is still being studied and is not yet a routine treatment in standard medical practice. It is being developed for Graves’ disease, a condition where the immune system overstimulates the thyroid gland, and it belongs to a group of medicines called monoclonal antibodies, which are designed to attach to a specific target in the body. At the molecular level, it works by binding to that target and blocking a signal that helps drive the disease process, which may help reduce thyroid overactivity and keep thyroid levels normal.

Investigated diseases

Graves disease - Graves disease is an autoimmune disorder in which the immune system causes the thyroid gland to make too much thyroid hormone. It usually develops gradually, with symptoms such as weight loss, shakiness, fast heartbeat, heat intolerance, and anxiety. The disease can come and go, and hormone levels may shift over time. In some people, the thyroid remains overactive for long periods, while in others it may settle into a quieter phase.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524001-33-00Protocol codeIMVT-1402-2505Estimated enrolment372 patientsSponsorImmunovant Sciences GmbH

sourced from the EU Clinical Trials Register and site verification

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