A Proof-of-Concept Study of AC-201 to Prevent Gout Flares

Inclusion Criteria: * Male or female age 20 to 80 years, inclusive * Meets at least 6 of the 12 American College of Rheumatology preliminary criteria (1977) for the classification of acute arthritis of primary gout, OR have proven tophus or documented monosodium urate (MSU) crystals in the joint fluid * Serum uric acid ≥7.5 mg/dL at screening * Experienced ≥2 gouty arthritis flares within one year prior to screening Exclusion Criteria: * Occurrence of a gouty arthritis flare ongoing at screening or during the screening period through baseline * Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 4 weeks prior to screening * Use of colchicine, glucocorticoids, NSAIDs, or COX-2 inhibitors within 1 week prior to screening * Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases with arthritis, or any condition requiring chronic daily use of pain medication * History of allergy to any components of study medication, including diacerein * Allergy, contraindication, or intolerance to febuxostat * Contraindication or allergy to NSAIDs * Severe renal impairment * Any prior use of biologic anti-inflammatory therapy, such as IL-1 modulators, tumor necrosis factor inhibitors, IL-6 inhibitors, or T-cell costimulation modulator