NCT06276556

Extension Study of ABP-671 in Participants With Gout

A Multicenter, Double-blind, Phase 2b/3 Extension Study to Assess the Safety and Efficacy of ABP-671 in Participants With Gout Who Completed the Double-blind Treatment Period in Study ABP-671-301

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Atom Therapeutics Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3).

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	ABP-671	Participants who were randomized to any of the ABP-671 treatment groups in Part 1 or Part 2 of Study ABP-671-301 will continue to receive the same dose level and dosing regimen during the Treatment Period of this Extension Study. Participants who were randomized to receive placebo in Part 1 or Part 2 of Study ABP-671-301 will receive ABP-671 during the Treatment Period of the Extension Study.
DRUG	Allopurinol	Participants who were randomized to receive allopurinol in Part 1 of Study ABP-671-301 will continue to receive allopurinol during the Treatment Period of the Extension Study.

Timeline

• Start date: 2024-04-22
• Primary completion: 2024-09-05
• Completion: 2024-09-05
• First posted: 2024-02-26
• Last updated: 2025-07-16

Locations

54 sites across 5 countries: United States, Australia, Georgia, Guatemala, Taiwan

Regulatory

• FDA-regulated drug study