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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Uncontrolled Gout

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Amgen

Last updated on ClinicalTrials.gov

October 19, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites