Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors

NCT01508702 | Completed Phase 3 Results DMC

• 2 other identifiers: RDEA594-3032011-003756-39
• Study Type: interventional
• Target: 214
• Locations: 7 countries
• Sites: 106

Brief Summary

This study will assess the serum uric acid lowering effects and safety of lesinurad compared to placebo in patients who are intolerant or have a contraindication to allopurinol or febuxostat.

Conditions

Gout

Keywords

Gout

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With an sUA Level That is < 6.0 mg/dL

  6 months

Study Arms (2)

lesinurad 400 mg

EXPERIMENTAL

Drug: lesinurad

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

lesinurad DRUG

Tablets, 400 mg QD

lesinurad 400 mg

Placebo DRUG

Tablets, Placebo QD

placebo

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 an sUA level ≥ 6.5 mg/dL at the Screening and Day -7 Visits.
• Subject must be able to take gout flare prophylaxis with colchicine or NSAID (including Cox-2 selective NSAID) ± PPI.
• Subject has a history (either by medical record or subject interview) of intolerance or a contraindication to either allopurinol or febuxostat.
• Body mass index (BMI) \< 45 kg/m2

You may not qualify if:

• Subject who is taking any other approved urate-lowering medication that is indicated for the treatment of gout at the Screening Visit.
• Subject with a documented history or suspicion of kidney stones.
• 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 a 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 active liver disease, or hepatic dysfunction.
• Subject receiving chronic treatment with more than 325 mg salicylates per day.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (106)

Unknown Facility

Birmingham, Alabama, 35211, United States

Location

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

Unknown Facility

Glendale, Arizona, 85308, United States

Location

Unknown Facility

Phoenix, Arizona, 85050, United States

Location

Unknown Facility

Tucson, Arizona, 85724, United States

Location

Unknown Facility

Jonesboro, Arkansas, 72401, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Anaheim, California, 92805, United States

Location

Unknown Facility

Carmichael, California, 95608, United States

Location

Unknown Facility

Covina, California, 91723, United States

Location

Unknown Facility

Huntington Park, California, 90255, United States

Location

Unknown Facility

Irvine, California, 92618, United States

Location

Unknown Facility

Colorado Springs, Colorado, 80922, United States

Location

Unknown Facility

Denver, Colorado, 80220, United States

Location

Unknown Facility

Denver, Colorado, 80230, United States

Location

Unknown Facility

Englewood, Colorado, 80113, United States

Location

Unknown Facility

Milford, Connecticut, 06460, United States

Location

Unknown Facility

Trumbull, Connecticut, 06611, United States

Location

Unknown Facility

Boynton Beach, Florida, 33472, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

Miami, Florida, 33135, United States

Location

Unknown Facility

Miami, Florida, 33143, United States

Location

Unknown Facility

Plant City, Florida, 33563, United States

Location

Unknown Facility

Port Orange, Florida, 32127, United States

Location

Unknown Facility

Tampa, Florida, 33607, United States

Location

Unknown Facility

Winter Haven, Florida, 33880, United States

Location

Unknown Facility

Newnan, Georgia, 30265, United States

Location

Unknown Facility

Honolulu, Hawaii, 96814, United States

Location

Unknown Facility

Meridian, Idaho, 83646, United States

Location

Unknown Facility

Chicago, Illinois, 60624, United States

Location

Unknown Facility

Elizabethtown, Kentucky, 42701, United States

Location

Unknown Facility

Lexington, Kentucky, 40504, United States

Location

Unknown Facility

Louisville, Kentucky, 40213, United States

Location

Unknown Facility

Metairie, Louisiana, 70006, United States

Location

Unknown Facility

South Traverse, Michigan, 49684, United States

Location

Unknown Facility

Jackson, Mississippi, 39202, United States

Location

Unknown Facility

Olive Branch, Mississippi, 38654, United States

Location

Unknown Facility

Southfield, Missouri, 48034, United States

Location

Unknown Facility

Washington, Missouri, 63090, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87102, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

Unknown Facility

Brooklyn, New York, 11201, United States

Location

Unknown Facility

Hartsdale, New York, 10530, United States

Location

Unknown Facility

New Windsor, New York, 12553, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

Hickory, North Carolina, 28602, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Fargo, North Dakota, 58103, United States

Location

Unknown Facility

Cincinnati, Ohio, 45224, United States

Location

Unknown Facility

Cincinnati, Ohio, 45242, United States

Location

Unknown Facility

Middleburg Heights, Ohio, 44130, United States

Location

Unknown Facility

Perrysburg, Ohio, 43551, United States

Location

Unknown Facility

Willoughby Hills, Ohio, 44904, United States

Location

Unknown Facility

Norman, Oklahoma, 73069, United States

Location

Unknown Facility

Jenkintown, Pennsylvania, 19046, United States

Location

Unknown Facility

Lancaster, Pennsylvania, 17601, United States

Location

Unknown Facility

Lansdale, Pennsylvania, 19446, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15237, United States

Location

Unknown Facility

Reading, Pennsylvania, 19606, United States

Location

Unknown Facility

Sellersville, Pennsylvania, 18960, United States

Location

Unknown Facility

Myrtle Beach, South Carolina, 29588, United States

Location

Unknown Facility

Rock Hill, South Carolina, 29732, United States

Location

Unknown Facility

Spartanburg, South Carolina, 29303, United States

Location

Unknown Facility

Brentwood, Tennessee, 37027, United States

Location

Unknown Facility

Spring Hill, Tennessee, 37174, United States

Location

Unknown Facility

Dallas, Texas, 75235, United States

Location

Unknown Facility

Houston, Texas, 77098, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Victoria, Texas, 77901, United States

Location

Unknown Facility

South Bountiful, Utah, 84010, United States

Location

Unknown Facility

West Jordon, Utah, 84088, United States

Location

Unknown Facility

West Layton, Utah, 84041, United States

Location

Unknown Facility

Chesapeake, Virginia, 23320, United States

Location

Unknown Facility

Richmond, Virginia, 23235, United States

Location

Unknown Facility

Suffolk, Virginia, 23435, United States

Location

Unknown Facility

Seattle, Washington, 98104, United States

Location

Unknown Facility

Spokane, Washington, 99208, United States

Location

Unknown Facility

Morgantown, West Virginia, 26505, United States

Location

Unknown Facility

Butterfield, Queensland, 4029, Australia

Location

Unknown Facility

Hobart, Tasmania, 7000, Australia

Location

Unknown Facility

Tasmania, 7000, Australia

Location

Unknown Facility

Anderlecht, Brussels Capital, 1070, Belgium

Location

Unknown Facility

Genk, Limburg, 3600, Belgium

Location

Unknown Facility

Gozée, 6534, Belgium

Location

Unknown Facility

Kortrijk, 8500, Belgium

Location

Unknown Facility

Yvoir, 5530, Belgium

Location

Unknown Facility

Coquitiam, British Columbia, V3K 3P4, Canada

Location

Unknown Facility

Coquitlam, British Columbia, V3K 3P4, Canada

Location

Unknown Facility

Victoria, British Columbia, V8V 3N7, Canada

Location

Unknown Facility

London, Ontario, N6A 5R8, Canada

Location

Unknown Facility

Mississauga, Ontario, L5M 2V8, Canada

Location

Unknown Facility

Toronto, Ontario, M9W 4L6, Canada

Location

Unknown Facility

Québec, Quebec, G1V 3M7, Canada

Location

Unknown Facility

Rimouski, Quebec, G5L 8W1, Canada

Location

Unknown Facility

Dresden, Saxony, 01307, Germany

Location

Unknown Facility

Leipzig, Saxony, 04109, Germany

Location

Unknown Facility

Dresden, 01069, Germany

Location

Unknown Facility

Tauranga, Bay of Plenty, 3143, New Zealand

Location

Unknown Facility

Auckland, 1010, New Zealand

Location

Unknown Facility

Auckland, 1023, New Zealand

Location

Unknown Facility

Durban, 4092, South Africa

Location

Unknown Facility

Pretoria, 0002, South Africa

Location

Unknown Facility

Rondebosch, 7700, South Africa

Location

Unknown Facility

Stellenbosch, 7600, South Africa

Location

Unknown Facility

Thabazimbi, 0380, South Africa

Location

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

• Tausche AK, Alten R, Dalbeth N, Kopicko J, Fung M, Adler S, Bhakta N, Storgard C, Baumgartner S, Saag K. Lesinurad monotherapy in gout patients intolerant to a xanthine oxidase inhibitor: a 6 month phase 3 clinical trial and extension study. Rheumatology (Oxford). 2017 Dec 1;56(12):2170-2178. doi: 10.1093/rheumatology/kex350.

  PMID: 29029210 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Gout

Interventions

lesinurad

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

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: January 10, 2012
• First Posted: January 12, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 12, 2016
• Results First Posted: February 12, 2016

Record last verified: 2015-07

Locations

CA (8); NZ (3); AU (3); ZA (5); BE (5); US (79); DE (3)