Conditions: Tophaceous Gout
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 330
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Lesinurad intervention 2: Lesinurad intervention 3: Placebo intervention 4: Febuxostat
Intervention descriptions: intervention 1: Tablets, 400 mg once daily (QD) intervention 2: Tablets, 200 mg QD intervention 3: Tablets, Placebo QD intervention 4: 80 mg

Protocol document: