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Taking people in United KingdomPhase 2

Rilzabrutinib for adults with Graves' disease

Tests 2 doses of rilzabrutinib in adults with Graves' disease.

Key facts

Who runs it
Sanofi
Where
Milton Keynes and Newcastle upon Tyne, United KingdomSee the 2 sitesAlso in 8 other countries, 22 sites
Trial code
Registry title
A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
Status
Recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
2 Sept 2025
Expected to end
11 Mar 2027
Type of study
Interventional, 2 groups
Treatments tested
  • Rilzabrutinib dose 1
  • Rilzabrutinib dose 2
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Graves' disease and an overactive thyroid, with or without active Graves' eye disease (Graves' orbitopathy).

Age
18 Years to 75 Years
Sex
All sexes can join.
Disease stage
Confirmed Graves' disease with active hyperthyroidism (overactive thyroid). Some people will also have active Graves' orbitopathy: a clinical activity score (CAS) ≥3 in the worse eye, plus one or more of: lid retraction ≥2 mm, moderate or severe soft tissue involvement, proptosis (bulging eye) ≥2 mm, or double vision that comes and goes or is constant.

Main reasons for not taking part

  • Overactive thyroid caused by something other than Graves' disease, such as toxic multinodular goiter or a thyroid nodule.
  • Past thyroid storm, or high risk of it.
  • Large goiter blocking the airway or needing surgery during the study.
  • Eye disease that threatens sight, needs urgent eye surgery, or reduced vision from optic nerve damage in the last 6 months.
  • Graves' orbitopathy symptoms that started >9 months before the study start.

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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
  • Sight threatening Graves' orbitopathy or decreased visual acuity due to optic neuropathy within the last 6 months
  • Corneal decompensation unresponsive to medical management

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in United Kingdom

Also in 8 other countries, 22 sites

  • Milton Keynes, BuckinghamshireHospital not named in the registryTaking people
  • Newcastle upon TyneHospital not named in the registryTaking people

About the trial

What the trial wants to find out

This is a parallel group, Phase 2, 2-arm study to measure the treatment effect and safety of rilzabrutinib dose 1 or rilzabrutinib dose 2 in participants with Graves' disease, with and without Graves' orbitopathy, aged 18 years or older.

Read full original descriptionShow less

Study details include:

* Screening period (up to 4 weeks). * Treatment period (up to 16 weeks). * Follow-up period (4 weeks). The number of visits will be up to 13.

The 2 groups in the trial

  • Rilzabrutinib dose 1Treatment being tested

    Rilzabrutinib

  • Rilzabrutinib dose 2Treatment being tested

    Rilzabrutinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
An Open-label Phase 2 Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
Plain-language title
Rilzabrutinib for adults with Graves' diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06984627, who can take part
Record updated
28 October 2026