A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease

  • STATUS
    Recruiting
  • End date
    Sep 23, 2026
  • participants needed
    30
  • sponsor
    Sanofi
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Updated on 14 May 2026
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Summary

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.

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.

Details
Condition Graves' Disease
Age 18years - 75years
Clinical Study IdentifierNCT06984627
SponsorSanofi
Last Modified on14 May 2026

Eligibility

 Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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