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Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)

StatusCompleted
PhasePhase 3
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 6 more changesShow less
    • Trial completed
    • Final enrollment: 866 participants (planned 750)
    • Primary completion date changed from estimate of Sep 2026 to Aug 31, 2026
    • Study completion date changed from estimate of Oct 2026 to Sep 18, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Secondary endpoints revised (4)v10
  3. Study sites: 89 to 83
    • Primary completion date: Apr 2026 to Sep 2026
    • Study completion date: Apr 2026 to Oct 2026
    v9
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 89 of 89 sites
    v8
  5. Study sites: 87 to 89v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 85 to 87v6
  2. Study sites: 78 to 85v5
  3. Site details revised at 19 of 78 sitesv4
  4. Study sites: 74 to 78v3
  5. Study sites: 4 to 74
    • Start date changed from estimate of Feb 2025 to Mar 11, 2025
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
Trial Details
NCT Number NCT06846515
Lead Sponsor Arthrosi Therapeutics
Conditions
(from sponsor)		 Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
Related terms Arthritis, Gouty, Gout, Hyperuricemia
Enrollment 866 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov