Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients

Exclusion Criteria

• •Receiving treatment with allopurinol, colchicine, probenecid, benzbromarone, or febuxostat within two weeks or pegloticase within six months prior to screening
• •Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder or organ transplant)
• •Diagnosis of xanthinuria
• •Fractional excretion of urate \> 10% at screening
• •History of documented or suspected kidney stones
• •Known infection with the human immunodeficiency virus (HIV) or history of viral hepatitis type B or C
• •A diagnosis of illicit drug or alcohol dependence or abuse within one year of screening
• •History of upper gastrointestinal (GI) bleeding, documented peptic ulcer disease (unless known H. pylori infection treated successfully without recurrence), within three years of screening
• •History of stroke, transient ischemic attack (TIA), acute myocardial infarction (MI), congestive heart failure (NYHA Class II-IV), angina pectoris, coronary intervention procedure (including but not limited to angioplasty, stent placement, coronary revascularization), lower extremity bypass procedure, systemic or intracoronary fibrinolytic therapy within five years of screening
• •History of cancer within five years of screening, with the following exceptions: adequately treated non-melanomatous skin cancers, non-metastatic prostate cancer or in situ cervical cancer
• •Patients with a history of bladder cancer, active bladder cancer or hematuria
• •Body mass index (BMI) \> 42 kg/m2 at screening
• •Current or expected requirement for anticoagulant therapy (except for aspirin ≤ 325 mg/day, clopidogrel \[Plavix\] ≤ 75 mg/day, or prasugrel \[Effient\] ≤ 10 mg/day)
• •Use of any of the following within eight weeks prior to screening: potent CYP3A4 inhibitors, cytotoxic agents (including azathioprine, mercaptopurine, cyclosporine, cyclophosphamide, etc.), ranolazine, digoxin, theophylline, sulphonylureas, thiazolidinediones (e.g., rosiglitazone or pioglitazone), atypical antipsychotic agents, ampicillin, amoxicillin, loop diuretics or phenytoin
• •Chronic treatment with NSAIDs (except for as needed \[prn\] use to treat acute events); per protocol a short course of oral NSAIDs may be used to treat flares during the study
• •Current or expected chronic treatment with systemic corticosteroids (topical, ophthalmic, intra-articular or inhaled corticosteroid at a dose \< 1600 μg/day is permitted); per protocol a short course of oral corticosteroid may be used to treat flares occurring during the study
• •History of intra-articular steroid injection to treat flare within four weeks of screening
• •Known hypersensitivity or intolerance to allopurinol or colchicine
• •Treatment with any other investigational therapy within 30 days or within five half lives, whichever is longer, prior to screening
• •Patients who received arhalofenate in a previous trial
• •Any other condition(s) that would compromise the safety of the patient, prevent compliance with the study protocol including ability to use an electronic diary, or compromise the quality of the clinical study, as judged by the Investigator and/or Medical Monitor