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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01493531




Registration number
NCT01493531
Ethics application status
Date submitted
13/12/2011
Date registered
16/12/2011
Date last updated
26/05/2016

Titles & IDs
Public title
Combining Lesinurad With Allopurinol in Inadequate Responders
Scientific title
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Allopurinol Compared to Allopurinol Alone in Subjects With Gout Who Have Had an Inadequate Hypouricemic Response to Standard of Care Allopurinol
Secondary ID [1] 0 0
2011-003767-29
Secondary ID [2] 0 0
RDEA594-302
Universal Trial Number (UTN)
Trial acronym
CLEAR 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lesinurad
Treatment: Drugs - Lesinurad
Treatment: Drugs - Placebo
Treatment: Drugs - Allopurinol

Experimental: lesinurad 200 mg + allopurinol -

Experimental: lesinurad 400 mg + allopurinol -

Placebo Comparator: Placebo + allopurinol -


Treatment: Drugs: Lesinurad
Tablets, 200 mg QD

Treatment: Drugs: Lesinurad
Tablets, 400 mg QD

Treatment: Drugs: Placebo
Tablets, Placebo QD

Treatment: Drugs: Allopurinol
Tablets

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6. - Proportion of subjects with an sUA level that is < 6.0 mg/dL by Month 6.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Gout Flares - Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12.
Timepoint [1] 0 0
12 Months
Secondary outcome [2] 0 0
Subjects With = 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12 - Proportion of subjects with = 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12
Timepoint [2] 0 0
12 months

Eligibility
Key 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 been taking allopurinol as the sole urate-lowering therapy indicated for
the treatment of gout for at least 8 weeks prior to the Screening Visit at a stable,
medically appropriate dose, as determined by the investigator, of at least 300 mg per
day (at least 200 mg for subjects with moderate renal impairment).

- Subject must be able to take gout flare prophylaxis with colchicine or an NSAID
(including Cox-2 selective NSAID) ±PPI.

- Subject has an sUA level = 6.5 mg/dL at the Screening Visit and = 6.0 mg/dL at Day -7
Visit.

- Subject has reported at least 2 gout flares in the prior 12 months.

- Body mass index (BMI) < 45 kg/m2
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject with known hypersensitivity or allergy to allopurinol.

- Subject who is taking any other approved urate-lowering medication that is indicated
for the treatment of gout other than allopurinol within 8 weeks of the Screening
Visit.

- 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 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 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 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Camperdown,
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- Wollongong
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- Bisbane
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- Herston
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- Woodville South
Recruitment hospital [6] 0 0
- Clayton
Recruitment hospital [7] 0 0
- Heidelberg West
Recruitment hospital [8] 0 0
- Perth
Recruitment hospital [9] 0 0
- Shenton Park
Recruitment postcode(s) [1] 0 0
2050 - Camperdown,
Recruitment postcode(s) [2] 0 0
2522 - Wollongong
Recruitment postcode(s) [3] 0 0
4152 - Bisbane
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [8] 0 0
6001 - Perth
Recruitment postcode(s) [9] 0 0
6008 - Shenton Park
Recruitment outside Australia
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Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ardea Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will compare the serum uric acid lowering effects, clinical benefits, and safety
of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who
have had an inadequate response to allopurinol.
Trial website
https://clinicaltrials.gov/show/NCT01493531
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris Storgard, MD
Address 0 0
Ardea Biosciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications