NCT05586971

Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients

A Randomized, Multi-regional, Double-blind, Double-dummy Parallel-group, Placebo and Allopurinol-controlled Phase 3 Study to Assess the Efficacy and Safety of Tigulixostat in Gout Patients With Hyperuricemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,202 (actual)
• Sponsor: LG Chem · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

Conditions

• Gout
• Hyperuricemia
• Gout Flare
• Tophi

Interventions

Type	Name	Description
DRUG	Tigulixostat	Xanthine Oxidase Inhibitor
DRUG	Allopurinol	Xanthine Oxidase Inhibitor
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2023-03-30
• Primary completion: 2025-05-06
• Completion: 2025-05-06
• First posted: 2022-10-19
• Last updated: 2025-07-22

Locations

279 sites across 21 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Colombia, Czechia, France, Georgia, Germany, Italy, Lithuania, Malaysia, New Zealand, Philippines, Poland, South Korea, Spain, Taiwan, Thailand

Regulatory

• FDA-regulated drug study