Combining Lesinurad With Allopurinol in Inadequate Responders (CLEAR 2)

April 20, 2016 updated by: Ardea Biosciences, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Allopurinol is the standard of care for the treatment of gout. Nevertheless, most patients treated with allopurinol do not achieve the recommended sUA target of < 6.0 mg/dL and need additional therapy to achieve the target. Probenecid and benzbromarone are URAT1 inhibitors, generally recommended as second-line agents for patients who are either resistant to or intolerant of allopurinol. However, benzbromarone is not available in the US and probenecid is rarely used. Consequently, there is a clear unmet medical need for a new safe and effective therapy for gout, such as lesinurad, a potent URAT1 inhibitor, that can be used in combination with allopurinol in patients not responding adequately to allopurinol monotherapy so that very high rates of response can be achieved by nearly all gout patients, rather than a minority.The subjects selected for this study will have moderate to severe gout with an inadequate response to allopurinol

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
610

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown,, New South Wales, Australia, 2050
      • Wollongong, New South Wales, Australia, 2522
    • Queensland
      • Bisbane, Queensland, Australia, 4152
      • Herston, Queensland, Australia, 4029
    • South Australia
      • Woodville South, South Australia, Australia, 5011
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Heidelberg West, Victoria, Australia, 3081
    • Western Australia
      • Perth, Western Australia, Australia, 6001
      • Shenton Park, Western Australia, Australia, 6008
  • Belgium
      • Gozee, Belgium, 6534
      • Kortrijk, Belgium, 8500
      • Lommel, Belgium, 3920
      • Mouscron, Belgium, 7700
      • Yvoir, Belgium, 5530
    • Limburg
      • Genk, Limburg, Belgium, 3600
  • Canada
      • Quebec, Canada, G1V3M7
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
      • Kamloops, British Columbia, Canada, V2C 1K7
      • Penticton, British Columbia, Canada, V2A 5C8
    • Newfoundland and Labrador
      • Paradise, Newfoundland and Labrador, Canada, A1L 1E5
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 2M5
    • Ontario
      • Corunna, Ontario, Canada, N0N 1G0
      • Kitchener, Ontario, Canada, N2M 5N6
      • Kitchener, Ontario, Canada, N2G 1H6
      • London, Ontario, Canada, N6A 5R8
      • Sudbury, Ontario, Canada, P3E 1H5
      • Sudbury, Ontario, Canada, P3A 1Y8
      • Thornhill, Ontario, Canada, L4J 1W3
      • Toronto, Ontario, Canada, M9W 4L6
  • Germany
      • Berlin, Germany, 14059
      • Dresden, Germany, 01307
      • Dresden, Germany, 01069
      • Eichstatt, Germany, 85072
      • Goch, Germany, 47574
      • Leipzig, Germany, 04109
      • Mannheim, Germany, 68161
      • Munich, Germany, 80336
      • Osnabruck, Germany, 49074
    • Sachsen
      • Kamenz, Sachsen, Germany, 01917
  • New Zealand
      • Auckland, New Zealand, 2025
      • Auckland, New Zealand, 1023
      • Takapuna, New Zealand, 0626
    • Bay of Plenty
      • Tauranga, Bay of Plenty, New Zealand, 3143
    • Christchurch
      • Becken ham, Christchurch, New Zealand, 8024
    • Hamilton
      • Garden Place, Hamilton, New Zealand, 3240
    • Rotorua
      • Bay of Plenty, Rotorua, New Zealand, 3010
  • Poland
      • Katowice, Poland, 40 954
      • Konskie, Poland, 26-200
      • Krakow, Poland, 31-501
      • Poznan, Poland, 60-773
      • Radom, Poland, 26 610
      • Warszawa, Poland, 01-192
      • Warszawa, Poland, 01-868
      • Wroclaw, Poland, 53-114
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-510
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-430
    • Warminsko-Mazurskie
      • Elblag, Warminsko-Mazurskie, Poland, 82 300
  • South Africa
      • Cape Town, South Africa, 7500
      • Durban, South Africa, 4001
      • East London, South Africa, 5201
      • Paarl, South Africa, 7646
      • Pretoria, South Africa, 0002
      • Pretoria, South Africa, 0084
      • Soweto, South Africa, 1804
      • Thabazimbi, South Africa, 0380
      • Witbank, South Africa, 1035
      • Worcester, South Africa, 6850
    • Bloemfontein
      • Fichardt Park, Bloemfontein, South Africa, 9301
    • Cape Town
      • Rondebosch, Cape Town, South Africa, 7700
    • Durban
      • Newlands, Durban, South Africa, 4037
      • Silverglen, Durban, South Africa, 4092
    • Johannesburg
      • Newtown, Johannesburg, South Africa, 2113
      • Parktown, Johannesburg, South Africa, 2193
      • Radiokop, Johannesburg, South Africa, 7700
    • Western Cape
      • Stellenbosch, Western Cape, South Africa, 7600
  • Spain
      • Merida, Spain, 06800
    • Galicia
      • La Coruna, Galicia, Spain, 15006
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
  • Switzerland
      • Lausanne, Switzerland, 1011
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
      • Kharkiv, Ukraine, 61176
      • Kharkiv, Ukraine, 61157
      • Kyiv, Ukraine, 03680
      • Kyiv, Ukraine, 01680
      • Lutsk, Ukraine, 43024
      • Poltava, Ukraine, 36011
      • Vinnytsia, Ukraine, 21018
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Chandler, Arizona, United States, 85224
      • Mesa, Arizona, United States, 85203
      • Pheonix, Arizona, United States, 85028
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
      • Jonesboro, Arkansas, United States, 72404
      • Little Rock, Arkansas, United States, 72223
    • California
      • Anaheim, California, United States, 92805
      • Gold River, California, United States, 95670
      • Irvine, California, United States, 92618
      • La Jolla, California, United States, 92037
      • Roseville, California, United States, 95661
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92123
      • San Ramon, California, United States, 94582
    • Colorado
      • Colorado Springs, Colorado, United States, 80922
      • Denver, Colorado, United States, 80220
      • Glenwood Springs, Colorado, United States, 81601
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
      • Washington DC, District of Columbia, United States, 20060
    • Florida
      • Boynton Beach, Florida, United States, 33472
      • Brandon, Florida, United States, 33511
      • Fleming Island, Florida, United States, 32003
      • Jacksonville, Florida, United States, 32205
      • Jacksonville, Florida, United States, 32216
      • Jupiter, Florida, United States, 33458
      • Plant City, Florida, United States, 33563
      • Tampa, Florida, United States, 33606
      • Tampa, Florida, United States, 33607
      • Winter Haven, Florida, United States, 33880
    • Georgia
      • Dunwoody, Georgia, United States, 30338
      • Roswell, Georgia, United States, 30075
      • Savannah, Georgia, United States, 31406
    • Idaho
      • Boise, Idaho, United States, 83702
      • Meridian, Idaho, United States, 83642
    • Illinois
      • Addison, Illinois, United States, 60101
      • Chicago, Illinois, United States, 60602
    • Indiana
      • Evansville, Indiana, United States, 47713
    • Kentucky
      • Lexington, Kentucky, United States, 40503
      • Lexington, Kentucky, United States, 40504
    • Maryland
      • Cumberland, Maryland, United States, 21502
      • Wheaton, Maryland, United States, 20902
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
      • Hyannis, Massachusetts, United States, 02601
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Flint, Michigan, United States, 48504
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
    • Missouri
      • Louis, Missouri, United States, 63117
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • Nevada
      • Reno, Nevada, United States, 89502
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • Brooklyn, New York, United States, 11201
      • Brooklyn, New York, United States, 11215
    • North Carolina
      • Calabash, North Carolina, United States, 28467
      • Charlotte, North Carolina, United States, 28210
      • Durham, North Carolina, United States, 27710
      • Hickory, North Carolina, United States, 28602
      • Shelby, North Carolina, United States, 28152
      • Winston-Salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Cleveland, Ohio, United States, 44122
      • Columbus, Ohio, United States, 43203
      • Dayton, Ohio, United States, 45424
      • Franklin, Ohio, United States, 45005
      • Middleburgh Heights, Ohio, United States, 44130
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
    • Oregon
      • Portland, Oregon, United States, 97239
      • Portland, Oregon, United States, 97220
    • Pennsylvania
      • Indiana, Pennsylvania, United States, 15701
      • Scottdale, Pennsylvania, United States, 15683
    • South Carolina
      • Greenville, South Carolina, United States, 29601
      • Greer, South Carolina, United States, 29651
      • Spartanburg, South Carolina, United States, 29303
      • Union, South Carolina, United States, 29379
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
      • Spring Hill, Tennessee, United States, 37174
    • Texas
      • Austin, Texas, United States, 78705
      • Austin, Texas, United States, 78758
      • Houston, Texas, United States, 77074
      • Irving, Texas, United States, 75061
      • Sugarland, Texas, United States, 77479
    • Utah
      • West Layton, Utah, United States, 84041
    • Virginia
      • Danville, Virginia, United States, 24541
      • Richmond, Virginia, United States, 23219
    • Washington
      • Seattle, Washington, United States, 98104
      • Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: lesinurad 200 mg + allopurinol
Drug: Lesinurad
Tablets, 200 mg QD
Drug: Lesinurad
Tablets, 400 mg QD
Drug: Allopurinol
Tablets
EXPERIMENTAL: lesinurad 400 mg + allopurinol
Drug: Lesinurad
Tablets, 200 mg QD
Drug: Lesinurad
Tablets, 400 mg QD
Drug: Allopurinol
Tablets
PLACEBO_COMPARATOR: Placebo + allopurinol
Drug: Placebo
Tablets, Placebo QD
Drug: Allopurinol
Tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.
Time Frame: 6 months
Proportion of subjects with an sUA level that is < 6.0 mg/dL by Month 6.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gout Flares
Time Frame: 12 Months
Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12.
12 Months
Subjects With ≥ 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12
Time Frame: 12 months
Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ardea Biosciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RDEA594-302
  • 2011-003767-29 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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