NCT06984627 A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease
| NCT ID | NCT06984627 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sanofi |
| Condition | Graves' Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-02 |
| Primary Completion | 2026-08-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-09-02 with a primary completion date of 2026-08-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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' 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.
Eligibility Criteria
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.
Contact & Investigator
Trial Transparency email recommended (Toll free for US & Canada)
✉ Contact-US@sanofi.com📞 800-633-1610
Frequently Asked Questions
Who can join the NCT06984627 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Graves' Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06984627 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06984627 currently recruiting?
Yes, NCT06984627 is actively recruiting participants. Contact the research team at Contact-US@sanofi.com for enrollment information.
Where is the NCT06984627 trial being conducted?
This trial is being conducted at Calgary, Canada, Surrey, Canada, Sherbrooke, Canada, Essen, Germany and 9 additional locations.
Who is sponsoring the NCT06984627 clinical trial?
NCT06984627 is sponsored by Sanofi. The trial plans to enroll 30 participants.