Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Lesinurad

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.