Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors (LIGHT)

January 14, 2016 updated by: Ardea Biosciences, Inc.

A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled Study to Assess the Efficacy and Safety of Lesinurad Monotherapy Compared to Placebo in Subjects With Gout and an Intolerance or Contraindication to a Xanthine Oxidase Inhibitor

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Allopurinol is the standard of care for the treatment of gout. In practice, approximately 20% of patients report side effects with allopurinol and 5% discontinue allopurinol due to side effects. Allopurinol can cause gastrointestinal intolerance, such as nausea and diarrhea, which appears to be dosedependent. Rash develops in about 2% of patients treated with allopurinol, and in about 20% of patients treated with allopurinol and ampicillin or amoxicillin. Allopurinol hypersensitivity syndrome remains a major concern among physicians. Mortality has been estimated to be up to nearly one quarter of AHS cases, with multiorgan system disease including hepatocellular changes and renal failure being a serious concern. Allopurinol is also relatively contraindicated for use in combination with 6-mercaptopurine and azathioprine, for which 1/4 to 1/3 lower doses must be given in order to avoid hematologic toxicity. Febuxostat, in clinical trials, has shown a similar AE profile to allopurinol. Liver function abnormalities, nausea, arthralgia and rash were the most commonly reported AEs. In postmarketing experience, Stevens Johnson Syndrome and hypersensitivity rashes have been reported (febuxostat prescribing information). Withdrawals due to AEs were similar in frequency to allopurinol as well. Relative contraindications in combination with 6-mercaptopurine and azathioprine are similar to allopurinol as well. Lesinurad may be an important therapeutic option for patients who either cannot tolerate or who have a contraindication to the use of allopurinol or febuxostat.

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Tasmania, Australia, 7000
    • Queensland
      • Butterfield, Queensland, Australia, 4029
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
  • Belgium
      • Gozee, Belgium, 6534
      • Kortrijk, Belgium, 8500
      • Yvoir, Belgium, 5530
    • Brussels
      • Anderlecht, Brussels, Belgium, 1070
    • Limburg
      • Genk, Limburg, Belgium, 3600
  • Canada
      • Quebec, Canada, G1V 3M7
    • British Columbia
      • Coquitiam, British Columbia, Canada, V3K 3P4
      • Coquitlam, British Columbia, Canada, V3K 3P4
      • Victoria, British Columbia, Canada, V8V 3N7
    • Ontario
      • London, Ontario, Canada, N6A 5R8
      • Mississauga, Ontario, Canada, L5M 2V8
      • Toronto, Ontario, Canada, M9W 4L6
    • Quebec
      • Rimouski, Quebec, Canada, G5L 8W1
  • Germany
      • Dresden, Germany, 01069
    • Saxony
      • Dresden, Saxony, Germany, 01307
      • Leipzig, Saxony, Germany, 04109
  • New Zealand
      • Auckland, New Zealand, 1023
      • Auckland, New Zealand, 1010
    • Bay of Plenty
      • Tauranga, Bay of Plenty, New Zealand, 3143
  • South Africa
      • Durban, South Africa, 4092
      • Pretoria, South Africa, 0002
      • Rondebosch, South Africa, 7700
      • Stellenbosch, South Africa, 7600
      • Thabazimbi, South Africa, 0380
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Birmingham, Alabama, United States, 35211
    • Arizona
      • Glendale, Arizona, United States, 85308
      • Phoenix, Arizona, United States, 85050
      • Tucson, Arizona, United States, 85724
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
      • Little Rock, Arkansas, United States, 72205
    • California
      • Anaheim, California, United States, 92805
      • Carmichael, California, United States, 95608
      • Covina, California, United States, 91723
      • Huntington Park, California, United States, 90255
      • Irvine, California, United States, 92618
    • Colorado
      • Colorado Springs, Colorado, United States, 80922
      • Denver, Colorado, United States, 80220
      • Denver, Colorado, United States, 80230
      • Englewood, Colorado, United States, 80113
    • Connecticut
      • Milford, Connecticut, United States, 06460
      • Trumbull, Connecticut, United States, 06611
    • Florida
      • Boynton Beach, Florida, United States, 33472
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33143
      • Miami, Florida, United States, 33135
      • Plant City, Florida, United States, 33563
      • Port Orange, Florida, United States, 32127
      • Tampa, Florida, United States, 33607
      • Winter Haven, Florida, United States, 33880
    • Georgia
      • Newman, Georgia, United States, 30265
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
    • Idaho
      • Meridian, Idaho, United States, 83646
    • Illinois
      • Chicago, Illinois, United States, 60624
    • Kentucky
      • Elizabethtown, Kentucky, United States, 42701
      • Lexington, Kentucky, United States, 40504
      • Louisville, Kentucky, United States, 40213
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Michigan
      • South Traverse, Michigan, United States, 49684
    • Mississippi
      • Jackson, Mississippi, United States, 39202
      • Olive Branch, Mississippi, United States, 38654
    • Missouri
      • Southfield, Missouri, United States, 48034
      • Washington, Missouri, United States, 63090
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • Brooklyn, New York, United States, 11201
      • Hartsdale, New York, United States, 10530
      • New Windsor, New York, United States, 12553
      • New York, New York, United States, 10016
    • North Carolina
      • Hickory, North Carolina, United States, 28602
      • Raleigh, North Carolina, United States, 27612
      • Winston-Salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45224
      • Middleburgh Heights, Ohio, United States, 44130
      • Perrysburgh, Ohio, United States, 43551
      • Willoughby Hills, Ohio, United States, 44904
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
      • Lancaster, Pennsylvania, United States, 17601
      • Lansdale, Pennsylvania, United States, 19446
      • Pittsburgh, Pennsylvania, United States, 15237
      • Reading, Pennsylvania, United States, 19606
      • Sellersville, Pennsylvania, United States, 18960
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29588
      • Rock Hill, South Carolina, United States, 29732
      • Spartanburg, South Carolina, United States, 29303
    • Tennessee
      • Brentwood, Tennessee, United States, 37027
      • Spring Hill, Tennessee, United States, 37174
    • Texas
      • Dallas, Texas, United States, 75235
      • Houston, Texas, United States, 77098
      • San Antonio, Texas, United States, 78229
      • Victoria, Texas, United States, 77901
    • Utah
      • South Bountiful, Utah, United States, 84010
      • West Jordon, Utah, United States, 84088
      • West Layton, Utah, United States, 84041
    • Virginia
      • Chesapeake, Virginia, United States, 23320
      • Richmond, Virginia, United States, 23235
      • Suffolk, Virginia, United States, 23435
    • Washington
      • Seattle, Washington, United States, 98104
      • Spokane, Washington, United States, 99208
    • West Virginia
      • Morgantown, West Virginia, United States, 26505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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 in the opinion of the Investigator and/or 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Placebo
Tablets, Placebo QD
Experimental: lesinurad 400 mg
Drug: lesinurad
Tablets, 400 mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects With an sUA Level That is < 6.0 mg/dL
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardea Biosciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

February 12, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDEA594-303
  • 2011-003756-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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