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Study on the Effects and Safety of Rilzabrutinib 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 evaluates the effectiveness and safety of rilzabrutinib as a treatment for Graves' disease. Graves' disease is an autoimmune disorder that causes the thyroid gland to produce too much thyroid hormone (hyperthyroidism). This excess thyroid activity can lead to symptoms such as rapid heartbeat, weight loss, anxiety, and in some cases, eye problems known as Graves' orbitopathy, which can cause bulging eyes, double vision, and eyelid retraction.

The purpose of this research is to determine if rilzabrutinib can reduce thyroid activity in people with Graves' disease. The study is open-label, which means both the participants and researchers know which treatment is being given. The medication targets specific components of the immune system that are involved in the disease process.

During the study, participants will receive rilzabrutinib and be monitored for changes in thyroid hormone levels (FT3 and FT4) and any side effects that may occur. Some participants in the study will have the eye-related symptoms of Graves' disease (Graves' orbitopathy). The researchers will evaluate how the medication affects both the thyroid function and these eye-related symptoms.

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

    Initial Screening

    Your participation begins with confirming your Graves' disease diagnosis with active hyperthyroidism. Some participants may also have active Graves' orbitopathy, which affects the eyes.

    If you have Graves' orbitopathy, this will be confirmed through an eye examination and a clinical activity score of 3 or higher in your most affected eye, along with symptoms such as lid retraction, soft tissue involvement, proptosis (bulging eyes), or double vision.

  2. Step 2

    Starting Treatment

    You will receive rilzabrutinib, which comes as a film-coated tablet. This is an open-label study, which means both you and the study doctor will know which medication you are taking.

    The study will monitor how rilzabrutinib affects your thyroid activity. You will need to take the medication as prescribed by your study doctor for the duration of the trial.

  3. Step 3

    Regular Monitoring

    Throughout the study, your thyroid hormone levels will be measured regularly, specifically Free T4 (FT4) and Free T3 (FT3) levels. These are hormones produced by your thyroid gland that are typically elevated in Graves' disease.

    The study will track the percent change in these hormone levels from your starting values, and whether they return to normal ranges during treatment.

  4. Step 4

    Safety Assessments

    You will undergo regular safety assessments to monitor for any side effects or health changes during the study.

    The study team will record any treatment-emergent adverse events (side effects that appear after starting treatment), serious adverse events, and adverse events of special interest.

  5. Step 5

    Contraception Requirements

    If you are able to have children, you must use effective contraception methods throughout the study period, consistent with local regulations for clinical trial participants.

  6. Step 6

    Study Completion

    The study is expected to run until July 2025, with final results analyzed by August 2026.

    After completing the treatment period, there may be a follow-up period to monitor your health after stopping the study medication.

Who can join the trial?

8 criteria

  • You must have a confirmed diagnosis of Graves' disease with active hyperthyroidism (overactive thyroid that produces too much hormone)
  • You may or may not have active Graves' orbitopathy (eye problems related to Graves' disease)
  • Some participants will need to have active eye problems with a clinical activity score (CAS) of 3 or higher in their most affected eye
  • These eye problems must include at least one of the following:
    • Lid retraction of 2 mm or more (eyelid pulled back too far)
    • Moderate or severe soft tissue involvement (swelling around the eyes)
    • Proptosis of 2 mm or more (bulging eyes)
    • Diplopia (double vision) that occurs occasionally or all the time
    • You must be willing to use contraception methods that comply with local regulations for clinical trial participants

Who cannot join the trial?

11 criteria

  • You cannot participate if you have had your thyroid gland removed (total or partial thyroidectomy).
  • You cannot participate if you've received radioactive iodine treatment (a treatment that uses radiation to damage thyroid cells).
  • You cannot participate if you're pregnant, breastfeeding, or planning to become pregnant during the study.
  • You cannot participate if you have serious liver problems or liver disease.
  • You cannot participate if you have serious kidney problems or kidney disease.
  • You cannot participate if you have active or serious infections.
  • You cannot participate if you have a history of blood clots.
  • You cannot participate if you have any other serious medical conditions that the study doctor thinks could make it unsafe for you to participate.
  • You cannot participate if you're currently using certain medications that might interact with the study drug.
  • You cannot participate if you have participated in another clinical trial within the past 30 days.
  • You cannot participate if you have allergies to the study drug or similar medications.
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Investigated drugs

Rilzabrutinib is a medication being studied to treat Graves' disease. It works by targeting and blocking a specific enzyme called Bruton's tyrosine kinase (BTK) that plays a role in the immune system. By inhibiting this enzyme, rilzabrutinib may help reduce the abnormal immune response that causes the thyroid gland to become overactive in people with Graves' disease.

What is already known about the treatment

Rilzabrutinib – This is an oral medication taken by mouth in pill form that is currently being investigated in clinical trials for treating Graves' disease, an autoimmune disorder affecting the thyroid gland. Rilzabrutinib works by inhibiting Bruton's tyrosine kinase (BTK), an enzyme important in B-cell function, thereby potentially reducing the autoimmune response that causes thyroid overactivity in Graves' disease. It belongs to the class of medications known as BTK inhibitors, which are being studied for various autoimmune conditions. The medication has not yet received full regulatory approval for Graves' disease treatment and is still undergoing Phase 2 clinical trials to determine its efficacy and safety profile.

Investigated diseases

Graves' disease - An autoimmune disorder that causes the thyroid gland to produce excessive thyroid hormones, a condition known as hyperthyroidism. In Graves' disease, the immune system creates antibodies that stimulate the thyroid gland, leading to overproduction of thyroid hormones such as free thyroxine (FT4) and free triiodothyronine (FT3). Common symptoms include weight loss, increased heart rate, anxiety, tremors, fatigue, and heat intolerance. Some patients may develop eye problems called Graves' ophthalmopathy, which can cause bulging eyes, double vision, and eye irritation. The disease typically develops gradually and may fluctuate in severity over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521023-75-00Protocol codePDY18663Estimated enrolment59 patientsSponsorSanofi-Aventis Recherche & Developpement

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).