NCT06229145

A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout

A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous KRYSTEXXA® (Pegloticase) Administered Every 4 Weeks Compared With KRYSTEXXA Administered Every 2 Weeks With Co-administration of Weekly Doses of Methotrexate, Followed by an Open-label Extension, in Participants With Uncontrolled Refractory Gout (FORWARD II)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to \< 6 mg/dL for at least 80% of the time.

Detailed description

Acquired from Horizon in 2024.

Conditions

• Gout

Interventions

Type	Name	Description
BIOLOGICAL	Pegloticase	IV infusion
DRUG	Methotrexate	Oral

Timeline

• Start date: 2024-03-18
• Primary completion: 2025-07-30
• Completion: 2026-03-11
• First posted: 2024-01-29
• Last updated: 2026-04-09

Locations

74 sites across 1 country: United States

Regulatory

• FDA-regulated drug study