Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients

Inclusion Criteria

• Known gout patients (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout
• Patients who have been taking at least 200 mg/day of allopurinol as the sole ULT for at least two weeks with a sUA of ≥ 6.5 mg/dL and ≤ 12 mg/dL at screening and ≥ 6.0 mg/dL and ≤ 12 mg/dL at Week -1 (Visit 2) randomization visit.

-OR -

• Patients who are not on ULT or are taking allopurinol 42 kg/m2
• Current or expected requirement for anticoagulant therapy (except for aspirin ≤ 325 mg/day)
• Rheumatoid arthritis or other autoimmune disease requiring ongoing treatment
• Current or expected treatment with potent CYP3A4 inhibitors (See Appendix 6), cytotoxic agents (azathioprine, mercaptopurine, cyclosporine, cyclophosphamide, etc.), ranolazine, digoxin, theophylline, sulphonylureas, thiazolidinediones, diuretics, atypical antipsychotic agents, ampicillin, amoxicillin or phenytoin
• Chronic treatment with NSAIDs (use to treat acute flares are permitted).
• Current or expected treatment with systemic corticosteroids (except topical, ophthalmic, intra-articular, or inhaled at a dose < 1600 μg/day) other than to treat acute flare
• Known hypersensitivity to allopurinol, colchicine, or aspirin
• Treatment with any other investigational therapy within the 30 days prior to screening, or patients who received at least one dose of study drug while enrolled in any previous or concomitant MBX-102 trial
• Any other condition that compromises the ability of the patient to provide informed consent or to comply with the objectives and procedures of this protocol, as judged by the investigator and/or medical monitor.