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A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry
    • Trial sites expanded: 38 → 41 locations
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 7 entries
  2. Trial sites expanded: 29 → 38 locationsv5
  3. Trial sites expanded: 17 → 29 locationsv4
  4. Trial sites expanded: 8 → 17 locationsv3
  5. Recruitment opened
    • Trial sites expanded: 0 → 8 locations
    • Start date changed from estimate of Apr 2026 to May 8, 2026
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.
Trial Details
NCT Number NCT07535034
Lead Sponsor Crystalys Therapeutics
Conditions
(from sponsor)		 Gout
Related terms Gout
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov