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

StatusRecruiting
PhasePhase 2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Aug 25, 2026 → Feb 11, 2027
See other at-risk trials from Sanofi

Record History

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  1. Primary completion pushed from Aug 25, 2026 to Feb 11, 2027
    • Trial sites expanded: 15 → 24 locations
    • Study completion pushed from Sep 23, 2026 to Mar 11, 2027
    • Eligibility criteria expanded, about 10 words
  2. Study sites: 13 to 15v8
  3. Site details revised at 1 of 13 sitesv7
  4. Study sites: 12 to 13v6
  5. Study Status, Eligibilityv5
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  1. Site details revised at 4 of 12 sitesv4
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 30, 2025 to Sep 2, 2025
    • Study sites: 0 to 12
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
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.
Trial Details
NCT Number NCT06984627
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Graves' Disease
Related terms Graves Disease
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov