NCT07388498

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

A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uncontrolled Gout

Interventions

Type	Name	Description
DRUG	Pegloticase	Participants will receive pegloticase either SC or IV.
DRUG	Methotrexate	MTX will be administered orally.

Timeline

• Start date: 2026-02-09
• Primary completion: 2028-05-23
• Completion: 2028-07-18
• First posted: 2026-02-05
• Last updated: 2026-03-31

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study