Clinical Trial

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

Recruiting Phase 3
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Summary
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.
Protocol Amendment History 5 changes
notable Trial sites expanded: 49 -> 53 locations 2026-06-19
notable Trial sites expanded: 37 -> 49 locations 2026-06-11
minor Completion moved earlier: 2028-07-18 -> 2028-06-18 2026-06-11
notable Trial sites expanded: 25 -> 37 locations 2026-05-05
notable Trial sites expanded: 17 -> 25 locations 2026-04-01
Trial Details
NCT Number NCT07388498
Lead Sponsor Amgen
Conditions Uncontrolled Gout
Enrollment 270 participants
Start Date 2026-02-09
Primary Completion 2028-06-18 (estimated)
Study Completion 2028-06-18 (estimated)
Updated on ClinicalTrials.gov 2026-07-10