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

Recruiting now · Phase 2

Conditions studied: Graves' Disease

In brief

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.

Key facts

Study ID

NCT06984627

Run by

Sanofi

People needed

30

Starts

2025-09-02

Expected to finish

2026-09-23

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number : 1240003 — Calgary, Alberta, Canada (enrolling)
• Investigational Site Number : 1240002 — Surrey, British Columbia, Canada (enrolling)
• Investigational Site Number : 1240001 — Sherbrooke, Quebec, Canada (enrolling)
• Investigational Site Number : 2760002 — Essen, Germany (enrolling)
• Investigational Site Number : 2760001 — Frankfurt, Germany (enrolling)
• Investigational Site Number : 3800005 — Merano, Bolzano / Bozen, Italy (enrolling)
• Investigational Site Number : 3800001 — Milan, Milano, Italy (enrolling)
• Investigational Site Number : 3800004 — Milan, Milano, Italy (enrolling)
• Investigational Site Number : 3800003 — Palermo, Italy (enrolling)
• Investigational Site Number : 3800002 — Pisa, Italy (enrolling)
• Investigational Site Number : 7240002 — Barcelona, Catalunya [Cataluña], Spain (enrolling)
• Investigational Site Number : 7240001 — Pamplona, Navarre, Spain (enrolling)
• Investigational Site Number : 7240004 — Seville, Sevilla, Spain (enrolling)
• Investigational Site Number : 8260003 — Milton Keynes, Buckinghamshire, United Kingdom (enrolling)
• Investigational Site Number : 8260001 — Newcastle upon Tyne, England, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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