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GoutPhase 3CLEAR 2NCT01493531

Combining Lesinurad With Allopurinol in Inadequate Responders

A Phase 3 study testing Lesinurad and Allopurinol in people with Gout, run by Ardea Biosciences, Inc. at 175 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Gout
What is being tested?
Lesinurad and Allopurinol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
610 participants
Where
175 sitesin 11 countries
Study dates
Dec 2011to Jul 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

175 sites in 11 countries.

175 sites in 11 countries

United States88 sites

  • Study site

    Addison, Illinois, 60101

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Anaheim, California, 92805

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Austin, Texas, 78705

  • Study site

    Austin, Texas, 78758

  • Study site

    Boise, Idaho, 83702

  • Study site

    Boynton Beach, Florida, 33472

  • Study site

    Brandon, Florida, 33511

  • Study site

    Brooklyn, New York, 11201

  • Study site

    Brooklyn, New York, 11215

  • Study site

    Calabash, North Carolina, 28467

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Chicago, Illinois, 60602

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Colorado Springs, Colorado, 80922

  • Study site

    Columbus, Ohio, 43203

  • Study site

    Cumberland, Maryland, 21502

  • Study site

    Danville, Virginia, 24541

  • Study site

    Dayton, Ohio, 45424

  • Study site

    Denver, Colorado, 80220

  • Study site

    Dunwoody, Georgia, 30338

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Evansville, Indiana, 47713

  • Study site

    Fall River, Massachusetts, 02720

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Fleming Island, Florida, 32003

  • Study site

    Flint, Michigan, 48504

  • Study site

    Franklin, Ohio, 45005

  • Study site

    Glenwood Springs, Colorado, 81601

  • Study site

    Gold River, California, 95670

  • Study site

    Greenville, South Carolina, 29601

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Houston, Texas, 77074

  • Study site

    Hyannis, Massachusetts, 02601

  • Study site

    Indiana, Pennsylvania, 15701

  • Study site

    Irvine, California, 92618

  • Study site

    Irving, Texas, 75061

  • Study site

    Jacksonville, Florida, 32205

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Jonesboro, Arkansas, 72404

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Knoxville, Tennessee, 37919

  • Study site

    La Jolla, California, 92037

  • Study site

    Lexington, Kentucky, 40503

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Little Rock, Arkansas, 72223

  • Study site

    Louis, Missouri, 63117

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Mesa, Arizona, 85203

  • Study site

    Middleburg Heights, Ohio, 44130

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Olive Branch, Mississippi, 38654

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Pheonix, Arizona, 85028

  • Study site

    Plant City, Florida, 33563

  • Study site

    Portland, Oregon, 97220

  • Study site

    Portland, Oregon, 97239

  • Study site

    Reno, Nevada, 89502

  • Study site

    Richmond, Virginia, 23219

  • Study site

    Roseville, California, 95661

  • Study site

    Roswell, Georgia, 30075

  • Study site

    San Diego, California, 92108

  • Study site

    San Diego, California, 92123

  • Study site

    San Ramon, California, 94582

  • Study site

    Savannah, Georgia, 31406

  • Study site

    Scottdale, Pennsylvania, 15683

  • Study site

    Seattle, Washington, 98104

  • Study site

    Shelby, North Carolina, 28152

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    Spring Hill, Tennessee, 37174

  • Study site

    Sugarland, Texas, 77479

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tampa, Florida, 33606

  • Study site

    Tampa, Florida, 33607

  • Study site

    Trumbull, Connecticut, 06611

  • Study site

    Union, South Carolina, 29379

  • Study site

    Washington D.C., District of Columbia, 20060

  • Study site

    Washington D.C., District of Columbia, 20422

  • Study site

    West Layton, Utah, 84041

  • Study site

    Wheaton, Maryland, 20902

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winter Haven, Florida, 33880

Other trials in United States

South Africa18 sites

  • Study site

    Cape Town, 7500

  • Study site

    Durban, 4001

  • Study site

    East London, 5201

  • Study site

    Fichardtpark, Bloemfontein, 9301

  • Study site

    Newlands, Durban, 4037

  • Study site

    Newtown, Johannesburg, 2113

  • Study site

    Paarl, 7646

  • Study site

    Parktown, Johannesburg, 2193

  • Study site

    Pretoria, 0002

  • Study site

    Pretoria, 0084

  • Study site

    Radiokop, Johannesburg, 7700

  • Study site

    Rondebosch, Cape Town, 7700

  • Study site

    Silverglen, Durban, 4092

  • Study site

    Soweto, 1804

  • Study site

    Stellenbosch, Western Cape, 7600

  • Study site

    Thabazimbi, 0380

  • Study site

    Witbank, 1035

  • Study site

    Worcester, 6850

Other trials in South Africa

Canada14 sites

  • Study site

    Coquitlam, British Columbia, V3K 3P4

  • Study site

    Corunna, Ontario, N0N 1G0

  • Study site

    Greater Sudbury, Ontario, P3A 1Y8

  • Study site

    Greater Sudbury, Ontario, P3E 1H5

  • Study site

    Halifax, Nova Scotia, B3K 2M5

  • Study site

    Kamloops, British Columbia, V2C 1K7

  • Study site

    Kitchener, Ontario, N2G 1H6

  • Study site

    Kitchener, Ontario, N2M 5N6

  • Study site

    London, Ontario, N6A 5R8

  • Study site

    Paradise, Newfoundland and Labrador, A1L 1E5

  • Study site

    Penticton, British Columbia, V2A 5C8

  • Study site

    Québec, Quebec, G1V3M7

  • Study site

    Thornhill, Ontario, L4J 1W3

  • Study site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

Poland11 sites

  • Study site

    Bialystok, Podlaskie Voivodeship, 15-430

  • Study site

    Elblag, Warmian-Masurian Voivodeship, 82 300

  • Study site

    Gmina Końskie, 26-200

  • Study site

    Katowice, 40 954

  • Study site

    Krakow, Lesser Poland Voivodeship, 30-510

  • Study site

    Krakow, 31-501

  • Study site

    Poznan, 60-773

  • Study site

    Radom, 26 610

  • Study site

    Warsaw, 01-192

  • Study site

    Warsaw, 01-868

  • Study site

    Wroclaw, 53-114

Other trials in Poland

Germany10 sites

  • Study site

    Berlin, 14059

  • Study site

    Dresden, 01069

  • Study site

    Dresden, 01307

  • Study site

    Eichstätt, 85072

  • Study site

    Goch, 47574

  • Study site

    Kamenz, Saxony, 01917

  • Study site

    Leipzig, 04109

  • Study site

    Mannheim, 68161

  • Study site

    Munich, 80336

  • Study site

    Osnabrück, 49074

Other trials in Germany

Australia9 sites

  • Study site

    Bisbane, Queensland, 4152

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Heidelberg West, Victoria, 3081

  • Study site

    Herston, Queensland, 4029

  • Study site

    Perth, Western Australia, 6001

  • Study site

    Shenton Park, Western Australia, 6008

  • Study site

    Wollongong, New South Wales, 2522

  • Study site

    Woodville South, South Australia, 5011

Other trials in Australia

Ukraine8 sites

  • Study site

    Dnipropetrovsk, 49005

  • Study site

    Kharkiv, 61157

  • Study site

    Kharkiv, 61176

  • Study site

    Kyiv, 01680

  • Study site

    Kyiv, 03680

  • Study site

    Lutsk, 43024

  • Study site

    Poltava, 36011

  • Study site

    Vinnytsia, 21018

Other trials in Ukraine

New Zealand7 sites

  • Study site

    Auckland, 1023

  • Study site

    Auckland, 2025

  • Study site

    Bay of Plenty, Rotorua, 3010

  • Study site

    Beckenham, Christchurch, 8024

  • Study site

    Garden Place, Hamilton, 3240

  • Study site

    Takapuna, 0626

  • Study site

    Tauranga, Bay of Plenty, 3143

Other trials in New Zealand

Belgium6 sites

  • Study site

    Genk, Limburg, 3600

  • Study site

    Gozée, 6534

  • Study site

    Kortrijk, 8500

  • Study site

    Lommel, 3920

  • Study site

    Mouscron, 7700

  • Study site

    Yvoir, 5530

Other trials in Belgium

Spain3 sites

  • Study site

    A Coruña, Galicia, 15006

  • Study site

    Barakaldo, Vizcaya, 48903

  • Study site

    Mérida, 06800

Other trials in Spain

Switzerland1 site

  • Study site

    Lausanne, 1011

Other trials in Switzerland

About this study

Official 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

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.

Read the 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

Conditions
Gout
Being tested
Lesinurad, Placebo, Allopurinol
Keywords
Gout
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LesinuradDrug

    Tablets, 200 mg QD

  • LesinuradDrug

    Tablets, 400 mg QD

  • PlaceboDrug

    Tablets, Placebo QD

  • AllopurinolDrug

    Tablets

Study groups in NCT01493531
Study groupRoleWhat they receive
lesinurad 200 mg + allopurinolExperimentalNot described
Receives: Drug: Lesinurad; Drug: Allopurinol
lesinurad 400 mg + allopurinolExperimentalNot described
Receives: Drug: Lesinurad; Drug: Allopurinol
Placebo + allopurinolPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Allopurinol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (2)

  1. 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.

    Measured: 12 Months

  2. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionMay 2014
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
610 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01493531
Sponsor's protocol ID
RDEA594-302
Other IDs
2011-003767-29
Acronym
CLEAR 2
Status last verified
Apr 2016
First submitted
13 Dec 2011
Last updated
26 May 2016
Data monitoring committee
Yes

Publications

  • Topless R, Noorbaloochi S, Merriman TR, Singh JA. Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout. Semin Arthritis Rheum. 2022 Oct;56:152057. doi: 10.1016/j.semarthrit.2022.152057. Epub 2022 Jun 29.

    PubMed 35835008

  • Bardin T, Keenan RT, Khanna PP, Kopicko J, Fung M, Bhakta N, Adler S, Storgard C, Baumgartner S, So A. Lesinurad in combination with allopurinol: a randomised, double-blind, placebo-controlled study in patients with gout with inadequate response to standard of care (the multinational CLEAR 2 study). Ann Rheum Dis. 2017 May;76(5):811-820. doi: 10.1136/annrheumdis-2016-209213. Epub 2016 Nov 7.

    PubMed 27821644

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lesinurad and Allopurinol in people with Gout, run by Ardea Biosciences, Inc. at 175 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, South Africa, Canada, Poland, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01493531, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2016.

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