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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
Started2026-02-09
View on ClinicalTrials.gov ↗
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.

Amendment history 7 changes detected by DataLookout

2026-09-04
minor
Trial sites expanded: 63 → 71 locations
2026-08-08
minor
Trial sites expanded: 57 → 63 locations
2026-06-19
minor
Trial sites expanded: 49 → 53 locations
2026-06-11
minor
Trial sites expanded: 37 → 49 locations
2026-06-11
minor
Completion moved earlier: 2028-07-18 → 2028-06-18
2026-05-05
minor
Trial sites expanded: 25 → 37 locations
2026-04-01
minor
Trial sites expanded: 17 → 25 locations
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 2026-09-03