NCT01510769

Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat

A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects With Tophaceous Gout

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.

Detailed description

Febuxostat is an XO (Xanthine Oxidase) Inhibitor approved Urate Lowering Therapy (ULT) for patients with gout. Although febuxostat has been demonstrated to be superior to allopurinol in lowering serum urate (sUA) to \< 6mg/dL in 3 randomized, controlled clinical trials, proportions of subjects experiencing a reduction in tophus area and gout flares were not significantly different compared to allopurinol. Although this study will allow subjects who are naïve to ULT to enroll, it is anticipated that the majority of subjects will currently be taking or have previously experienced XO Inhibitor therapy. This trial will enroll a population of subjects with high uric acid body burden, as all must demonstrate the presence of tophi.

Conditions

• Tophaceous Gout

Interventions

Type	Name	Description
DRUG	Lesinurad	Tablets, 400 mg once daily (QD)
DRUG	Lesinurad	Tablets, 200 mg QD
DRUG	Placebo	Tablets, Placebo QD
DRUG	Febuxostat	80 mg

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-01-16
• Last updated: 2016-05-26
• Results posted: 2016-05-26

Locations

124 sites across 6 countries: United States, Australia, Canada, New Zealand, Poland, Switzerland