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New pill could tame overactive thyroid in Graves' disease

NCT ID NCT06984627

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This phase 2 trial tests two doses of rilzabrutinib, an oral drug, in 30 adults with Graves' disease (with or without eye problems). The main goal is to see if the drug lowers high thyroid hormone levels over 16 weeks. Researchers will also monitor safety and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rilzabrutinib
What this could lead to
If successful, this could point toward a new oral treatment option for Graves' disease that helps control thyroid hormone levels without lifelong medication.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply broadly. The drug may not effectively lower thyroid hormones or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants who have a confirmed diagnosis of Graves' disease with active hyperthyroidism, with or without active Graves' orbitopathy at the time of screening. * A subset of participants will have a diagnosis of active Graves' orbitopathy, as confirmed by ophthalmic exam at screening and a clinical activity score (CAS) ≥3 for the most severely affected eye, and associated with one or more of the following: lid retraction ≥2 mm, moderate or severe soft tissue involvement, proptosis ≥2 mm, and/or intermittent or constant diplopia. * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * History of hyperthyroidism not caused by Graves' disease (eg, hyperthyroidism due to toxic multinodular goiter, autonomous thyroid nodule, acute inflammatory thyroiditis). * History of thyroid storm or at high risk of developing thyroid storm as determined by evaluating clinician. * Enlarged thyroid goiter causing upper airway obstruction and/or requiring surgical intervention during the study period. * For participant with Graves' orbitopathy, requires immediate surgical ophthalmological intervention or is planning corrective surgery/irradiation during the course of the study. * Sight threatening Graves' orbitopathy or decreased visual acuity due to optic neuropathy within the last 6 months. * Corneal decompensation unresponsive to medical management. * Onset of Graves' orbitopathy symptoms \>9 months prior to baseline. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

Graves disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Graves disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    15 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Investigational Site Number : 1240001

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Investigational Site Number : 1240002

    RECRUITING

    Surrey, British Columbia, V3T 4G8, Canada

  • Investigational Site Number : 1240003

    RECRUITING

    Calgary, Alberta, T2N 4L7, Canada

  • Investigational Site Number : 2760001

    RECRUITING

    Frankfurt, 60590, Germany

  • Investigational Site Number : 2760002

    RECRUITING

    Essen, 45147, Germany

  • Investigational Site Number : 3800001

    RECRUITING

    Milan, Milano, 20122, Italy

  • Investigational Site Number : 3800002

    RECRUITING

    Pisa, 56126, Italy

  • Investigational Site Number : 3800003

    RECRUITING

    Palermo, 90127, Italy

  • Investigational Site Number : 3800004

    RECRUITING

    Milan, Milano, 20132, Italy

  • Investigational Site Number : 3800005

    RECRUITING

    Merano, Bolzano / Bozen, 39100, Italy

  • Investigational Site Number : 7240001

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240002

    RECRUITING

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Investigational Site Number : 7240004

    RECRUITING

    Seville, Sevilla, 41009, Spain

  • Investigational Site Number : 8260001

    RECRUITING

    Newcastle upon Tyne, England, NE2 4HH, United Kingdom

  • Investigational Site Number : 8260003

    RECRUITING

    Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom

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