NCT05818085

Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout

A Multicenter, Randomized, Double-blind, Controlled, Phase 2b/3 Study to Assess the Efficacy and Safety of ABP-671 in Participants With Gout

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Atom Therapeutics Co., Ltd · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, Phase 2b/3 study to evaluate the efficacy and safety of ABP-671. Part 1 of the study will compare the efficacy and safety of different doses and regimens of ABP-671 with placebo and allopurinol. Part 2 of the study will compare the dosing regimen(s) of ABP-671 selected from Part 1 with placebo in participants who have not been enrolled for Part 1.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	ABP-671	Low, medium or high dose (Part 1); Selected dose(s) (Part 2)
DRUG	Allopurinol	Standard of care according to American College of Rheumatology (ACR) guideline for the management of gout
OTHER	Placebo	ABP-671 matching placebo

Timeline

• Start date: 2023-08-11
• Primary completion: 2025-01-30
• Completion: 2025-03-30
• First posted: 2023-04-18
• Last updated: 2025-12-22

Locations

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

Regulatory

• FDA-regulated drug study