Combination Treatment Study in Subjects with Tophaceous Gout With Lesinurad and Febuxostat - CRYSTAL

Exclusion Criteria

• - Subject with known hypersensitivity or allergy to febuxostat.
• - Subject who is taking any approved urate-lowering medication other than allopurinol or febuxostat that is indicated for the treatment of gout within 8 weeks of the Screening Visit.
• - Subject who previously received pegloticase.
• - Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
• - Subject with a history or suspicion of drug abuse within the past 5 years.
• - Subject with a history of myositis/myopathy or rhabdomyolysis.
• - Subject that requires or may require systemic immunosuppressive or immunomodulatory treatment.
• - Subject with known or suspected human immunodeficiency virus (HIV) infection.
• - Subject with a positive test for active hepatitis B or hepatitis C infection.
• - Subject with a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.
• - Subject within the last 12 months with: unstable angina, New York Heart Association thrombosis; or subjects currently receiving anticoagulants.
• - Subject with uncontrolled hypertension.
• - Subject with an estimated creatinine clearance < 30 mL/min.
• - Subjects with a creatine kinase > 2.5 x ULN at any time during the Screening Period.
• - Subject with active peptic ulcer disease requiring treatment.
• - Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.
• - Subject receiving chronic treatment with more than 325 mg of salicylates per day.
• - Subject taking valpromide, progabide, or valproic acid.
• - Subject who has received an investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit.
• - Subject with any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.