Combining Lesinurad With Allopurinol in Inadequate Responders
CLEAR 1
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.
1 other identifier
interventional
607
1 country
165
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2012
Typical duration for phase_3
165 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 11, 2012
CompletedFirst Posted
Study publicly available on registry
January 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
August 18, 2016
CompletedAugust 18, 2016
July 1, 2016
2.5 years
January 11, 2012
January 21, 2016
July 11, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects With an sUA Level That is < 6.0 mg/dL
6 Months, analysis after all subjects complete 12 months
Secondary Outcomes (2)
Gout Flares
12 Months
Tophus
12 Months
Study Arms (3)
lesinurad 200 mg + allopurinol
EXPERIMENTALlesinurad 400 mg + allopurinol
EXPERIMENTALPlacebo + allopurinol
PLACEBO COMPARATORInterventions
Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (165)
Unknown Facility
Athens, Alabama, 35611, United States
Unknown Facility
Birmingham, Alabama, 35209, United States
Unknown Facility
Birmingham, Alabama, 35213, United States
Unknown Facility
Birmingham, Alabama, 35242, United States
Unknown Facility
Birmingham, Alabama, 35294, United States
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Gulf Shores, Alabama, 36542, United States
Unknown Facility
Mobile, Alabama, 36604, United States
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Mobile, Alabama, 36608, United States
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Pinson, Alabama, 35126, United States
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Glendale, Arizona, 85308, United States
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Goodyear, Arizona, 85395, United States
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Little Rock, Arizona, 72204, United States
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Little Rock, Arizona, 72211, United States
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Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85050, United States
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Tucson, Arizona, 85704, United States
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Tuscon, Arizona, 85723, United States
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Little Rock, Arkansas, 72206, United States
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Covina, California, 91723, United States
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Glendale, California, 91204, United States
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Huntington Beach, California, 92646, United States
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Inglewood, California, 90301, United States
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Lancaster, California, 93534, United States
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Lincoln, California, 95648, United States
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Orange, California, 92868, United States
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Sacramento, California, 95825, United States
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San Leandro, California, 94578, United States
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Santa Maria, California, 93454, United States
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Colorado Springs, Colorado, 80907, United States
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Colorado Springs, Colorado, 80918, United States
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Denver, Colorado, 80230, United States
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Englewood, Colorado, 80113, United States
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Milford, Connecticut, 06460, United States
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New London, Connecticut, 06320, United States
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Brooksville, Florida, 34601, United States
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Clearwater, Florida, 33765, United States
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Daytona Beach, Florida, 32114, United States
Unknown Facility
East Bradenton, Florida, 34208, United States
Unknown Facility
Gainesville, Florida, 32607, United States
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Miami, Florida, 33125, United States
Unknown Facility
Miami, Florida, 33135, United States
Unknown Facility
Miami, Florida, 33143, United States
Unknown Facility
Miami, Florida, 33165, United States
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Miami, Florida, 33186, United States
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Naples, Florida, 34102, United States
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Ocala, Florida, 34474, United States
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Ormond Beach, Florida, 32174, United States
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Pembroke Pines, Florida, 33027, United States
Unknown Facility
Pembroke Pines, Florida, 33029, United States
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Port Orange, Florida, 32127, United States
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Tampa, Florida, 33614, United States
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Vero Beach, Florida, 32960, United States
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Atlanta, Georgia, 30308, United States
Unknown Facility
Atlanta, Georgia, 30328, United States
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Augusta, Georgia, 30909, United States
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Conyers, Georgia, 30013, United States
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Johns Creek, Georgia, 30097, United States
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Marietta, Georgia, 30060, United States
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Newnan, Georgia, 30265, United States
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Honolulu, Hawaii, 96814, United States
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Idaho Falls, Idaho, 83404, United States
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Meridian, Idaho, 83642, United States
Unknown Facility
Meridian, Idaho, 83646, United States
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Chicago, Illinois, 60612, United States
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Gurnee, Illinois, 60031, United States
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Evansville, Indiana, 47714, United States
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Franklin, Indiana, 46131, United States
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La Porte, Indiana, 46350, United States
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Cedar Rapids, Iowa, 52403, United States
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Shawnee, Kansas, 66218, United States
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Elizabethtown, Kentucky, 41701, United States
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Paducah, Kentucky, 42003, United States
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Eunice, Louisiana, 70535, United States
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Metairie, Louisiana, 70006, United States
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Monroe, Louisiana, 71203, United States
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Natchitoches, Louisiana, 71457, United States
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Worcester, Massachusetts, 01605, United States
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Ann Arbor, Michigan, 48106, United States
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Kalamazoo, Michigan, 49009, United States
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Southfield, Michigan, 48034, United States
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Traverse City, Michigan, 49684, United States
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Jackson, Mississippi, 39202, United States
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Florissant, Missouri, 63031, United States
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Hazelwood, Missouri, 63042, United States
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Jefferson City, Missouri, 65109, United States
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Kansas City, Missouri, 64114, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, 63128, United States
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Washington, Missouri, 63090, United States
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Missoula, Montana, 59808, United States
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Las Vegas, Nevada, 89119, United States
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Las Vegas, Nevada, 89183, United States
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Albuquerque, New Mexico, 87102, United States
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Endwell, New York, 13760, United States
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New York, New York, 10016, United States
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Syracuse, New York, 13210, United States
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Williamsville, New York, 14221, United States
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Greensboro, North Carolina, 27405, United States
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Raleigh, North Carolina, 27609, United States
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Raleigh, North Carolina, 27612, United States
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Shelby, North Carolina, 28150, United States
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Tabor City, North Carolina, 28463, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Columbus, Ohio, 43235, United States
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Dayton, Ohio, 45417, United States
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Perrysburg, Ohio, 43551, United States
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Willoughby Hills, Ohio, 44904, United States
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Oklahoma City, Oklahoma, 73103, United States
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Tulsa, Oklahoma, 74104, United States
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Ashland, Oregon, 97520, United States
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Altoona, Pennsylvania, 16602, United States
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Belle Vernon, Pennsylvania, 15012, United States
Unknown Facility
Clairton, Pennsylvania, 15025, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
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Jenkintown, Pennsylvania, 19046, United States
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Lansdale, Pennsylvania, 19446, United States
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Pittsburgh, Pennsylvania, 15206, United States
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Sellersville, Pennsylvania, 18960, United States
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Upper Saint Clair, Pennsylvania, 15241, United States
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Wexford, Pennsylvania, 15090, United States
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Columbia, South Carolina, 29204, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Myrtle Beach, South Carolina, 29588, United States
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Rock Hill, South Carolina, 29732, United States
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Spartanburg, South Carolina, 29303, United States
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Brentwood, Tennessee, 37027, United States
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Jackson, Tennessee, 38305, United States
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Knoxville, Tennessee, 37923, United States
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Memphis, Tennessee, 38119, United States
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Austin, Texas, 78756, United States
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Corpus Christi, Texas, 78414, United States
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Dallas, Texas, 75218, United States
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El Paso, Texas, 79902, United States
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Fort Worth, Texas, 76135, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77043, United States
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Houston, Texas, 77062, United States
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Houston, Texas, 77098, United States
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Kingwood, Texas, 77339, United States
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Nassau Bay, Texas, 77058, United States
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Plabo, Texas, 75024, United States
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Plano, Texas, 75075, United States
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San Angelo, Texas, 76904, United States
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San Antonio, Texas, 78209, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
San Antonio, Texas, 78229, United States
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Sealy, Texas, 77474, United States
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Waco, Texas, 76708, United States
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Bountiful, Utah, 84010, United States
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Salt Lake City, Utah, 84102, United States
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West Jordan, Utah, 84088, United States
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Chesapeake, Virginia, 23320, United States
Unknown Facility
Manassas, Virginia, 20110, United States
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Midlothian, Virginia, 23114, United States
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Richmond, Virginia, 23233, United States
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Richmond, Virginia, 23235, United States
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Suffolk, Virginia, 23435, United States
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Virginia Beach, Virginia, 23462, United States
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Port Orchard, Washington, 98366, United States
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Spokane, Washington, 99204, United States
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Spokane, Washington, 99208, United States
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Morgantown, West Virginia, 26505, United States
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Milwaukee, Wisconsin, 53226, United States
Unknown Facility
Monroe, Wisconsin, 53566, United States
Related Publications (2)
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.
PMID: 35835008DERIVEDSaag 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.
PMID: 27564409DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nihar Bhakta, MD
- Organization
- Ardea Biosciences, MD
Study Officials
- STUDY DIRECTOR
Chris Storgard, MD
Ardea Biosciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2012
First Posted
January 13, 2012
Study Start
January 1, 2012
Primary Completion
July 1, 2014
Study Completion
August 1, 2014
Last Updated
August 18, 2016
Results First Posted
August 18, 2016
Record last verified: 2016-07