Lesinurad and Febuxostat Combination Extension Study in Gout

NCT01808144 | Completed Phase 3 Results DMC

• 2 other identifiers: RDEA594-3072012-004390-54
• Study Type: interventional
• Target: 196
• Locations: 6 countries
• Sites: 72

Brief Summary

This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.

Conditions

Gout

Keywords

Gout

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an sUA Level That is < 5.0 mg/dL

  Percentage of participants in Study 307 With sUA \< 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases

  Up to approximately 2.5 years (at Extension Month 12)

Secondary Outcomes (1)

• Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus

  Up to approximatley 2.5 years (at Extension Month 12)

Study Arms (2)

lesinurad 400 mg + febuxostat 80 mg

EXPERIMENTAL

Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.

Drug: lesinurad; Drug: febuxostat

lesinurad 200 mg + febuxostat 80 mg

EXPERIMENTAL

Drug: lesinurad; Drug: febuxostat

Interventions

lesinurad DRUG

Tablets, 400 mg once daily (QD)

lesinurad 400 mg + febuxostat 80 mg

febuxostat DRUG

Tabletsm 80 mg QD

lesinurad 200 mg + febuxostat 80 mg; lesinurad 400 mg + febuxostat 80 mg

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 and the risks involved and is willing to provide written informed consent before the first study related activity.
• Subject completed the double-blind treatment period in Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg at the Month 12 visit.
• Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.

You may not qualify if:

• Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, 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.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (72)

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Birmingham, Alabama, 35211, United States

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Tempe, Arizona, 85282, 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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Irvine, California, 92618, United States

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San Diego, California, 92108, United States

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Denver, Colorado, 80220, United States

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Englewood, Colorado, 80113, United States

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Boynton Beach, Florida, 33472, United States

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Naples, Florida, 34102, United States

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Pembroke Pines, Florida, 33027, United States

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Tampa, Florida, 33606, United States

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Tampa, Florida, 33614, United States

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Winter Haven, Florida, 33880, United States

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Johns Creek, Georgia, 30097, United States

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Honolulu, Hawaii, 96814, United States

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Meridian, Idaho, 83646, United States

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Gurnee, Illinois, 60031, United States

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Springfield, Illinois, 62704, United States

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Elizabethtown, Kentucky, 42701, United States

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Frederick, Maryland, 21702, United States

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Ann Arbor, Michigan, 48109, United States

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Southfield, Michigan, 48034, United States

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Jackson, Mississippi, 39202, United States

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Olive Branch, Mississippi, 38654, United States

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Jefferson City, Missouri, 65109, United States

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St Louis, Missouri, 63117, United States

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New York, New York, 10036, United States

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Wilmington, North Carolina, 28401, United States

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Fargo, North Dakota, 58103, United States

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Columbus, Ohio, 43203, United States

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Middleburg Heights, Ohio, 44130, United States

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Wadsworth, Ohio, 44281, United States

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Oklahoma City, Oklahoma, 73103, United States

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Belle Vernon, Pennsylvania, 15012, 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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Columbia, South Carolina, 29204, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Spartanburg, South Carolina, 29303, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78758, United States

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Dallas, Texas, 75218, United States

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Houston, Texas, 77074, United States

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San Antonio, Texas, 78229, United States

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Sugar Land, Texas, 77479, United States

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Victoria, Texas, 77901, United States

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Waco, Texas, 76710, United States

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Chesapeake, Virginia, 23320, United States

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Danville, Virginia, 24541, United States

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Richmond, Virginia, 23235, United States

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Seattle, Washington, 98104, United States

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Morgantown, West Virginia, 26505, United States

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Camperdown, New South Wales, 2050, Australia

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Woodville South, South Australia, 5011, Australia

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Hobart, Tasmania, 7000, Australia

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Mississauga, Ontario, L5M 2V8, Canada

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Toronto, Ontario, M9W4L6, Canada

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Grafton, Auckland, 1023, New Zealand

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Tauranga, 3143, New Zealand

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Poznan, Greater Poland Voivodeship, 60-773, Poland

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Kutno, Iodzkie, 99-300, Poland

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Krakow, Lesser Poland Voivodeship, 30-510, Poland

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Krakow, Lesser Poland Voivodeship, 31-501, Poland

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Bialystok, Podlaskie Voivodeship, 15-430, Poland

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Katowice, Silesian Voivodeship, 40-954, Poland

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Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

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Gmina Końskie, Świętokrzyskie Voivodeship, 26-200, Poland

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Fribourg, 1705, Switzerland

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Fribourg, 1708, Switzerland

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MeSH Terms

Conditions

Gout

Interventions

lesinurad; Febuxostat

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)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

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

nbhakta@ardeabio.com

1-858-652-6671

Study Officials

• Nihar Bhakta, 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 11, 2013
• Study Start: March 1, 2013
• Primary Completion: August 9, 2016
• Study Completion: October 6, 2016
• Last Updated: January 30, 2018
• Results First Posted: January 30, 2018

Record last verified: 2018-01

Locations

US (55); CH (2); NZ (2); CA (2); PL (8); AU (3)