A Double-blind, Randomized Controlled Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of Pegloticase Administration Via Subcutaneous and Intravenous Routes Both With Methotrexate in Participants With Uncontrolled Gout

StatusRecruiting
PhasePhase 3
SponsorAmgen
Started

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Record History

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  1. Trial sites expanded: 71 → 75 locations
    • Eligibility criteria shortened, about 8 words
  2. Trial sites expanded: 63 → 71 locationsv12
  3. Trial sites expanded: 57 → 63 locationsv11
  4. Study sites: 56 to 57v10
  5. Study sites: 55 to 56v9
  6. Study sites: 53 to 55v8
  7. Trial sites expanded: 49 → 53 locationsv7
  8. Trial sites expanded: 37 → 49 locations
    • Study completion moved earlier from Jul 18, 2028 to Jun 18, 2028
    • Primary completion date: May 23, 2028 to Jun 18, 2028
    v6
  9. Trial sites expanded: 25 → 37 locationsv5
  10. Trial sites expanded: 17 → 25 locationsv4
  11. Study sites: 1 to 17v3
  12. Start date changed from estimate of Feb 19, 2026 to Feb 9, 2026v2
  13. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Amgen
169 trials monitored
See 11 trials at risk
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to \< 6 mg/dL for at least 80% of the time during Month 6.
Trial Details
NCT Number NCT07388498
Lead Sponsor Amgen
Conditions
(from sponsor)		 Uncontrolled Gout
Enrollment 270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov