Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
Condition: Gout
MeSH terms: Gout
Intervention: lesinurad; Placebo
Intervention description: Tablets, 400 mg QD; Tablets, Placebo QD
Intervention MeSH terms: Lesinurad
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Gout

Summary:

      This study will assess the serum uric acid lowering effects and safety of lesinurad compared
      to placebo in patients who are intolerant or have a contraindication to allopurinol or
      febuxostat.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is able to understand the study procedures, the risks involved and willing to
             provide written informed consent before the first study related activity.

          -  Subject meets the diagnosis of gout as per the American Rheumatism Association
             Criteria for the Classification of Acute Arthritis of Primary Gout.

          -  Subject has an sUA level ≥ 6.5 mg/dL at the Screening and Day -7 Visits.

          -  Subject must be able to take gout flare prophylaxis with colchicine or NSAID
             (including Cox-2 selective NSAID) ± PPI.

          -  Subject has a history (either by medical record or subject interview) of intolerance
             or a contraindication to either allopurinol or febuxostat.

          -  Body mass index (BMI) < 45 kg/m2

        Exclusion Criteria:

          -  Subject who is taking any other approved urate-lowering medication that is indicated
             for the treatment of gout at the Screening Visit.

          -  Subject with a documented history or suspicion of kidney stones.

          -  Subject who is pregnant or breastfeeding.

          -  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 that requires or may require systemic immunosuppressive or immunomodulatory
             treatment.

          -  Subject with a 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
             class III or IV heart failure, myocardial infarction, stroke, or deep venous
             thrombosis; or subjects currently receiving anticoagulants.

          -  Subject with uncontrolled hypertension.

          -  Subject with an estimated creatinine clearance < 30 mL/min.

          -  Subject with active peptic ulcer disease requiring treatment.

          -  Subject with active liver disease, or hepatic dysfunction.

          -  Subject receiving chronic treatment with more than 325 mg 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.