Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-05-14; most recent amendment 2026-07-06.
Status change: Not Yet Recruiting → Recruiting 2025-09-04
Trial Details
NCT Number NCT06984627
Lead Sponsor Sanofi
Conditions Graves' Disease
Enrollment 30 participants
Start Date 2025-09-02
Primary Completion 2026-08-25 (estimated)
Study Completion 2026-09-23 (estimated)
Updated on ClinicalTrials.gov 2026-07-07