NCT05253833

Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout

A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study With Two Optional Extensions to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous Gout Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Arthrosi Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.

Conditions

• Gout
• Arthritis, Gouty
• Hyperuricemia
• Gout Chronic

Interventions

Type	Name	Description
DRUG	AR882 Dose 1	Solid Oral Capsule
DRUG	AR882 Dose 2	Solid Oral Capsule
DRUG	Allopurinol Tablet	Solid tablet

Timeline

• Start date: 2022-08-12
• Primary completion: 2024-08-13
• Completion: 2024-10-28
• First posted: 2022-02-24
• Last updated: 2025-01-29

Locations

12 sites across 3 countries: United States, New Zealand, Taiwan

Regulatory

• FDA-regulated drug study