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

Study identifier:RDEA594-304

ClinicalTrials.gov identifier:NCT01510769

EudraCT identifier:2011-003768-55

CTIS identifier:N/A

Study Complete

Official Title

A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects with Tophaceous Gout

Medical condition

Tophaceous Gout

Phase

Phase 3

Healthy volunteers

Study drug

Lesinurad, Placebo, Febuxostat

Sex

All

Actual Enrollment

330

Study type

Interventional

Age

18 Years - 85 Years

Date

Study Start Date: 01 Jan 2012

Primary Completion Date: 01 Jun 2014

Study Completion Date: 01 Jun 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2016 by Ardea Biosciences, Inc.

Collaborators

Inclusion and exclusion 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 is willing to adhere to the visit/protocol schedules.
- Subject meets the diagnosis of gout as per the American Rheumatism Association
- Criteria for the Classification of Acute Arthritis of Primary Gout.
- Subject meets one of the following criteria:
- Subjects who are not currently taking an approved ULT must have an sUA value of ≥ 8 mg/dL (476 µmol/L).
- Subjects entering the study on a medically appropriate dose of febuxostat or allopurinol must have an sUA value of ≥ 6.0 mg/dL (357 µmol/L).
- Subject must be able to take gout flare prophylaxis with colchicine or non-steroidal anti-inflammatory drug (NSAID) (including Cox-2 selective NSAID) ± PPI.
- Subject with at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 20 mm in the longest diameter.
- Body mass index (BMI) < 45 kg/m2

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.

No locations available

Arms	Assigned Interventions
Experimental: lesinurad 400 mg + febuxostat 80 mg	Drug: Lesinurad Tablets, 400 mg once daily (QD) Drug: Febuxostat 80 mg
Experimental: lesinurad 200 mg + febuxostat 80 mg	Drug: Lesinurad Tablets, 200 mg QD Drug: Febuxostat 80 mg
Placebo Comparator: placebo + febuxostat 80 mg	Drug: Placebo Tablets, Placebo QD Drug: Febuxostat 80 mg

Documents available

http://www.gouttrial.com
Download

Contacts

Contact

L Grubbs

858-652-6599

Investigators

Principal Investigator

Chris Storgard

Ardea Biosciences, Inc.