Status:
RECRUITING
A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
Lead Sponsor:
Sanofi
Conditions:
Graves' Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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'...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 23 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06984627
Start Date
September 2 2025
End Date
September 23 2026
Last Update
December 17 2025
Active Locations (12)
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1
Investigational Site Number : 1240003
Calgary, Alberta, Canada, T2N 4L7
2
Investigational Site Number : 1240002
Surrey, British Columbia, Canada, V3T 2V6
3
Investigational Site Number : 1240001
Sherbrooke, Quebec, Canada, J1H 5N4
4
Investigational Site Number : 2760002
Essen, Germany, 45147