Combining Lesinurad With Allopurinol in Inadequate Responders

NCT01493531 | Completed Phase 3 Results DMC

• 2 other identifiers: RDEA594-3022011-003767-29
• Study Type: interventional
• Target: 610
• Locations: 11 countries
• Sites: 175

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.

Conditions

Gout

Keywords

Gout

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (2)

• Gout Flares

  12 Months

• Subjects With ≥ 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12

  12 months

Study Arms (3)

lesinurad 200 mg + allopurinol

EXPERIMENTAL

Drug: Lesinurad; Drug: Allopurinol

lesinurad 400 mg + allopurinol

EXPERIMENTAL

Drug: Lesinurad; Drug: Allopurinol

Placebo + allopurinol

PLACEBO COMPARATOR

Drug: Placebo; Drug: Allopurinol

Interventions

Lesinurad DRUG

Tablets, 200 mg QD

lesinurad 200 mg + allopurinol

Placebo DRUG

Tablets, Placebo QD

Placebo + allopurinol

Allopurinol DRUG

Tablets

Placebo + allopurinol; lesinurad 200 mg + allopurinol; lesinurad 400 mg + allopurinol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (175)

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Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85224, United States

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Mesa, Arizona, 85203, United States

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Pheonix, Arizona, 85028, United States

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Jonesboro, Arkansas, 72401, United States

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Jonesboro, Arkansas, 72404, United States

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Little Rock, Arkansas, 72223, United States

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Anaheim, California, 92805, United States

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Gold River, California, 95670, United States

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Irvine, California, 92618, United States

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La Jolla, California, 92037, United States

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Roseville, California, 95661, United States

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San Diego, California, 92108, United States

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San Diego, California, 92123, United States

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San Ramon, California, 94582, United States

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Colorado Springs, Colorado, 80922, United States

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Denver, Colorado, 80220, United States

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Glenwood Springs, Colorado, 81601, United States

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Trumbull, Connecticut, 06611, United States

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Washington D.C., District of Columbia, 20060, United States

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Washington D.C., District of Columbia, 20422, United States

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Boynton Beach, Florida, 33472, United States

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Brandon, Florida, 33511, United States

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Fleming Island, Florida, 32003, United States

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Jacksonville, Florida, 32205, United States

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Jacksonville, Florida, 32216, United States

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Jupiter, Florida, 33458, United States

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Plant City, Florida, 33563, United States

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Tampa, Florida, 33606, United States

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Tampa, Florida, 33607, United States

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Winter Haven, Florida, 33880, United States

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Dunwoody, Georgia, 30338, United States

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Roswell, Georgia, 30075, United States

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Savannah, Georgia, 31406, United States

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Boise, Idaho, 83702, United States

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Meridian, Idaho, 83642, United States

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Addison, Illinois, 60101, United States

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Chicago, Illinois, 60602, United States

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Evansville, Indiana, 47713, United States

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Lexington, Kentucky, 40503, United States

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Lexington, Kentucky, 40504, United States

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Cumberland, Maryland, 21502, United States

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Wheaton, Maryland, 20902, United States

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Fall River, Massachusetts, 02720, United States

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Hyannis, Massachusetts, 02601, United States

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Ann Arbor, Michigan, 48109, United States

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Flint, Michigan, 48504, United States

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Olive Branch, Mississippi, 38654, United States

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Louis, Missouri, 63117, United States

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Omaha, Nebraska, 68114, United States

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Reno, Nevada, 89502, United States

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Albuquerque, New Mexico, 87106, United States

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Brooklyn, New York, 11201, United States

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Brooklyn, New York, 11215, United States

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Calabash, North Carolina, 28467, United States

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Charlotte, North Carolina, 28210, United States

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Durham, North Carolina, 27710, United States

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Hickory, North Carolina, 28602, United States

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Shelby, North Carolina, 28152, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45242, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43203, United States

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Dayton, Ohio, 45424, United States

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Franklin, Ohio, 45005, United States

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Middleburg Heights, Ohio, 44130, United States

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Oklahoma City, Oklahoma, 73103, United States

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Portland, Oregon, 97220, United States

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Portland, Oregon, 97239, United States

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Indiana, Pennsylvania, 15701, United States

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Scottdale, Pennsylvania, 15683, United States

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Greenville, South Carolina, 29601, United States

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Greer, South Carolina, 29651, United States

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Spartanburg, South Carolina, 29303, United States

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Union, South Carolina, 29379, United States

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Knoxville, Tennessee, 37919, United States

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Spring Hill, Tennessee, 37174, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78758, United States

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Houston, Texas, 77074, United States

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Irving, Texas, 75061, United States

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Sugarland, Texas, 77479, United States

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West Layton, Utah, 84041, United States

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Danville, Virginia, 24541, United States

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Richmond, Virginia, 23219, United States

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Seattle, Washington, 98104, United States

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Tacoma, Washington, 98405, United States

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Camperdown, New South Wales, 2050, Australia

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Wollongong, New South Wales, 2522, Australia

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Bisbane, Queensland, 4152, Australia

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Herston, Queensland, 4029, Australia

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Woodville South, South Australia, 5011, Australia

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Clayton, Victoria, 3168, Australia

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Heidelberg West, Victoria, 3081, Australia

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Perth, Western Australia, 6001, Australia

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Shenton Park, Western Australia, 6008, Australia

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Genk, Limburg, 3600, Belgium

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Gozée, 6534, Belgium

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Kortrijk, 8500, Belgium

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Lommel, 3920, Belgium

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Mouscron, 7700, Belgium

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Yvoir, 5530, Belgium

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Coquitlam, British Columbia, V3K 3P4, Canada

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Kamloops, British Columbia, V2C 1K7, Canada

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Penticton, British Columbia, V2A 5C8, Canada

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Paradise, Newfoundland and Labrador, A1L 1E5, Canada

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Halifax, Nova Scotia, B3K 2M5, Canada

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Corunna, Ontario, N0N 1G0, Canada

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Greater Sudbury, Ontario, P3A 1Y8, Canada

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Greater Sudbury, Ontario, P3E 1H5, Canada

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Kitchener, Ontario, N2G 1H6, Canada

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Kitchener, Ontario, N2M 5N6, Canada

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London, Ontario, N6A 5R8, Canada

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Thornhill, Ontario, L4J 1W3, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Québec, Quebec, G1V3M7, Canada

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Kamenz, Saxony, 01917, Germany

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Berlin, 14059, Germany

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Dresden, 01069, Germany

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Dresden, 01307, Germany

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Eichstätt, 85072, Germany

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Goch, 47574, Germany

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Leipzig, 04109, Germany

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Mannheim, 68161, Germany

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Munich, 80336, Germany

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Osnabrück, 49074, Germany

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Tauranga, Bay of Plenty, 3143, New Zealand

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Beckenham, Christchurch, 8024, New Zealand

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Garden Place, Hamilton, 3240, New Zealand

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Bay of Plenty, Rotorua, 3010, New Zealand

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Auckland, 1023, New Zealand

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Auckland, 2025, New Zealand

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Takapuna, 0626, New Zealand

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Krakow, Lesser Poland Voivodeship, 30-510, Poland

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Bialystok, Podlaskie Voivodeship, 15-430, Poland

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Elblag, Warmian-Masurian Voivodeship, 82 300, Poland

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Gmina Końskie, 26-200, Poland

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Katowice, 40 954, Poland

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Krakow, 31-501, Poland

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Poznan, 60-773, Poland

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Radom, 26 610, Poland

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Warsaw, 01-192, Poland

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Warsaw, 01-868, Poland

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Wroclaw, 53-114, Poland

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Fichardtpark, Bloemfontein, 9301, South Africa

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Rondebosch, Cape Town, 7700, South Africa

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Newlands, Durban, 4037, South Africa

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Silverglen, Durban, 4092, South Africa

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Newtown, Johannesburg, 2113, South Africa

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Parktown, Johannesburg, 2193, South Africa

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Radiokop, Johannesburg, 7700, South Africa

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Stellenbosch, Western Cape, 7600, South Africa

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Cape Town, 7500, South Africa

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Durban, 4001, South Africa

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East London, 5201, South Africa

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Paarl, 7646, South Africa

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Pretoria, 0002, South Africa

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Pretoria, 0084, South Africa

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Soweto, 1804, South Africa

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Thabazimbi, 0380, South Africa

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Witbank, 1035, South Africa

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Worcester, 6850, South Africa

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A Coruña, Galicia, 15006, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Mérida, 06800, Spain

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Lausanne, 1011, Switzerland

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Dnipropetrovsk, 49005, Ukraine

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Kharkiv, 61157, Ukraine

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Kharkiv, 61176, Ukraine

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Kyiv, 01680, Ukraine

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Kyiv, 03680, Ukraine

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Lutsk, 43024, Ukraine

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Poltava, 36011, Ukraine

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Vinnytsia, 21018, Ukraine

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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: 35835008 DERIVED

• 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.

  PMID: 27821644 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Gout

Interventions

lesinurad; Allopurinol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Nihar Bhakta, MD
• Organization: Ardea Biosciences, Inc.

nbhakta@ardeabio.com

1-858-652-6671

Study Officials

• Chris Storgard, MD

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: December 16, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 26, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-04

Locations

CH (1); DE (10); PL (11); CA (14); US (88); AU (9); BE (6); NZ (7); ES (3); ZA (18); UA (8)