Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)

A Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Tranilast in Combination With Allopurinol in Patients With Moderate to Severe Gout (TAnGO)

This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout.

Inclusion Criteria:

• Male or female, aged 18 to 80
• Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the presence of at least one gout tophus or gouty arthritis
• Hyperuricemia with a sUA ≥8.0 mg/dL

Exclusion Criteria:

• Pregnant or nursing
• Known hypersensitivity to any of the components of tranilast or allopurinol
• Known history of xanthinuria or kidney stones
• Use of an investigational drug within 30 days
• Presence of, or history of, cancer with the exception of completely excised, non-metastatic squamous cell and basal cell carcinomas of the skin
• Subject is planning or likely to require a surgical procedure during the study