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GoutPhase 3CLEAR 1NCT01510158

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 165 sites in United States.

Completed

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

Official record
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Trial summary

This study that 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
607 participants
Where
165 sitesUnited States
Study dates
Jan 2012to Aug 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 Nonsteroidal anti-inflammatory drug (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

165 sites in 1 country.

165 sites in 1 country

United States165 sites

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Altoona, Pennsylvania, 16602

  • Study site

    Ann Arbor, Michigan, 48106

  • Study site

    Ashland, Oregon, 97520

  • Study site

    Athens, Alabama, 35611

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Austin, Texas, 78756

  • Study site

    Belle Vernon, Pennsylvania, 15012

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Birmingham, Alabama, 35213

  • Study site

    Birmingham, Alabama, 35242

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Bountiful, Utah, 84010

  • Study site

    Brentwood, Tennessee, 37027

  • Study site

    Brooksville, Florida, 34601

  • Study site

    Cedar Rapids, Iowa, 52403

  • Study site

    Chesapeake, Virginia, 23320

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Clairton, Pennsylvania, 15025

  • Study site

    Clearwater, Florida, 33765

  • Study site

    Colorado Springs, Colorado, 80907

  • Study site

    Colorado Springs, Colorado, 80918

  • Study site

    Columbia, South Carolina, 29204

  • Study site

    Columbus, Ohio, 43235

  • Study site

    Conyers, Georgia, 30013

  • Study site

    Corpus Christi, Texas, 78414

  • Study site

    Covina, California, 91723

  • Study site

    Dallas, Texas, 75218

  • Study site

    Dayton, Ohio, 45417

  • Study site

    Daytona Beach, Florida, 32114

  • Study site

    Denver, Colorado, 80230

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    East Bradenton, Florida, 34208

  • Study site

    El Paso, Texas, 79902

  • Study site

    Elizabethtown, Kentucky, 41701

  • Study site

    Endwell, New York, 13760

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Eunice, Louisiana, 70535

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Florissant, Missouri, 63031

  • Study site

    Fort Worth, Texas, 76135

  • Study site

    Franklin, Indiana, 46131

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Glendale, Arizona, 85308

  • Study site

    Glendale, California, 91204

  • Study site

    Goodyear, Arizona, 85395

  • Study site

    Greensboro, North Carolina, 27405

  • Study site

    Gulf Shores, Alabama, 36542

  • Study site

    Gurnee, Illinois, 60031

  • Study site

    Hazelwood, Missouri, 63042

  • Study site

    Honolulu, Hawaii, 96814

  • Study site

    Houston, Texas, 77004

  • Study site

    Houston, Texas, 77043

  • Study site

    Houston, Texas, 77062

  • Study site

    Houston, Texas, 77098

  • Study site

    Huntington Beach, California, 92646

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Inglewood, California, 90301

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Jefferson City, Missouri, 65109

  • Study site

    Jenkintown, Pennsylvania, 19046

  • Study site

    Johns Creek, Georgia, 30097

  • Study site

    Kalamazoo, Michigan, 49009

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Kingwood, Texas, 77339

  • Study site

    Knoxville, Tennessee, 37923

  • Study site

    La Porte, Indiana, 46350

  • Study site

    Lancaster, California, 93534

  • Study site

    Lansdale, Pennsylvania, 19446

  • Study site

    Las Vegas, Nevada, 89119

  • Study site

    Las Vegas, Nevada, 89183

  • Study site

    Lincoln, California, 95648

  • Study site

    Little Rock, Arizona, 72204

  • Study site

    Little Rock, Arizona, 72211

  • Study site

    Little Rock, Arkansas, 72206

  • Study site

    Manassas, Virginia, 20110

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Meridian, Idaho, 83646

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33125

  • Study site

    Miami, Florida, 33135

  • Study site

    Miami, Florida, 33143

  • Study site

    Miami, Florida, 33165

  • Study site

    Miami, Florida, 33186

  • Study site

    Midlothian, Virginia, 23114

  • Study site

    Milford, Connecticut, 06460

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Missoula, Montana, 59808

  • Study site

    Mobile, Alabama, 36604

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Monroe, Louisiana, 71203

  • Study site

    Monroe, Wisconsin, 53566

  • Study site

    Morgantown, West Virginia, 26505

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Myrtle Beach, South Carolina, 29588

  • Study site

    Naples, Florida, 34102

  • Study site

    Nassau Bay, Texas, 77058

  • Study site

    Natchitoches, Louisiana, 71457

  • Study site

    New London, Connecticut, 06320

  • Study site

    New York, New York, 10016

  • Study site

    Newnan, Georgia, 30265

  • Study site

    Ocala, Florida, 34474

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Orange, California, 92868

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Paducah, Kentucky, 42003

  • Study site

    Pembroke Pines, Florida, 33027

  • Study site

    Pembroke Pines, Florida, 33029

  • Study site

    Peoria, Arizona, 85381

  • Study site

    Perrysburg, Ohio, 43551

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Pinson, Alabama, 35126

  • Study site

    Pittsburgh, Pennsylvania, 15206

  • Study site

    Plabo, Texas, 75024

  • Study site

    Plano, Texas, 75075

  • Study site

    Port Orange, Florida, 32127

  • Study site

    Port Orchard, Washington, 98366

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Richmond, Virginia, 23233

  • Study site

    Richmond, Virginia, 23235

  • Study site

    Rock Hill, South Carolina, 29732

  • Study site

    Sacramento, California, 95825

  • Study site

    Salt Lake City, Utah, 84102

  • Study site

    San Angelo, Texas, 76904

  • Study site

    San Antonio, Texas, 78209

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Leandro, California, 94578

  • Study site

    Santa Maria, California, 93454

  • Study site

    Sealy, Texas, 77474

  • Study site

    Sellersville, Pennsylvania, 18960

  • Study site

    Shawnee, Kansas, 66218

  • Study site

    Shelby, North Carolina, 28150

  • Study site

    Southfield, Michigan, 48034

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    Spokane, Washington, 99204

  • Study site

    Spokane, Washington, 99208

  • Study site

    St Louis, Missouri, 63117

  • Study site

    St Louis, Missouri, 63128

  • Study site

    Suffolk, Virginia, 23435

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tabor City, North Carolina, 28463

  • Study site

    Tampa, Florida, 33614

  • Study site

    Traverse City, Michigan, 49684

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Tuscon, Arizona, 85723

  • Study site

    Upper Saint Clair, Pennsylvania, 15241

  • Study site

    Vero Beach, Florida, 32960

  • Study site

    Virginia Beach, Virginia, 23462

  • Study site

    Waco, Texas, 76708

  • Study site

    Washington, Missouri, 63090

  • Study site

    West Jordan, Utah, 84088

  • Study site

    Wexford, Pennsylvania, 15090

  • Study site

    Williamsville, New York, 14221

  • Study site

    Willoughby Hills, Ohio, 44904

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Worcester, Massachusetts, 01605

Other trials in United States

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 that 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 serum urate (sUA) target of < 6.0 mg/dL and need additional therapy to achieve the target. Probenecid and benzbromarone are uric acid transporter 1 (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
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 once daily (qd)

  • LesinuradDrug

    Tablets, 400 mg qd

  • PlaceboDrug

    Tablets, Placebo qd

  • AllopurinolDrug

    Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)

  • AllopurinolDrug

    Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)

  • AllopurinolDrug

    Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)

Study groups in NCT01510158
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. Proportion of Subjects With an sUA Level That is < 6.0 mg/dL

    Measured: 6 Months, analysis after all subjects complete 12 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. Tophus

    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 posted13 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2014
  4. Study completionAug 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
Double blind
Who is masked
Participant, Care provider
Enrolment
607 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01510158
Sponsor's protocol ID
RDEA594-301
Acronym
CLEAR 1
Status last verified
Jul 2016
First submitted
11 Jan 2012
Last updated
18 Aug 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

  • Saag KG, Fitz-Patrick D, Kopicko J, Fung M, Bhakta N, Adler S, Storgard C, Baumgartner S, Becker MA. Lesinurad Combined With Allopurinol: A Randomized, Double-Blind, Placebo-Controlled Study in Gout Patients With an Inadequate Response to Standard-of-Care Allopurinol (a US-Based Study). Arthritis Rheumatol. 2017 Jan;69(1):203-212. doi: 10.1002/art.39840.

    PubMed 27564409

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 165 sites in United States.

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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States. 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 18 Aug 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?

Proportion of Subjects With an sUA Level That is < 6.0 mg/dL (time frame: 6 Months, analysis after all subjects complete 12 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 NCT01510158, 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 18 Aug 2016.

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