AzTrials
AzTrials

GoutPhase 3LIGHTNCT01508702

Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors

A Phase 3 study testing lesinurad in people with Gout, run by Ardea Biosciences, Inc. at 106 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Gout
What is being tested?
lesinurad
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
214 participants
Where
106 sitesin 7 countries
Study dates
Jan 2012to Nov 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

106 sites in 7 countries.

106 sites in 7 countries

United States79 sites

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Anaheim, California, 92805

  • Study site

    Birmingham, Alabama, 35211

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boynton Beach, Florida, 33472

  • Study site

    Brentwood, Tennessee, 37027

  • Study site

    Brooklyn, New York, 11201

  • Study site

    Carmichael, California, 95608

  • Study site

    Chesapeake, Virginia, 23320

  • Study site

    Chicago, Illinois, 60624

  • Study site

    Cincinnati, Ohio, 45224

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Colorado Springs, Colorado, 80922

  • Study site

    Covina, California, 91723

  • Study site

    Dallas, Texas, 75235

  • Study site

    Denver, Colorado, 80220

  • Study site

    Denver, Colorado, 80230

  • Study site

    Elizabethtown, Kentucky, 42701

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Glendale, Arizona, 85308

  • Study site

    Hartsdale, New York, 10530

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Honolulu, Hawaii, 96814

  • Study site

    Houston, Texas, 77098

  • Study site

    Huntington Park, California, 90255

  • Study site

    Irvine, California, 92618

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jenkintown, Pennsylvania, 19046

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Lancaster, Pennsylvania, 17601

  • Study site

    Lansdale, Pennsylvania, 19446

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Louisville, Kentucky, 40213

  • Study site

    Meridian, Idaho, 83646

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Miami, Florida, 33135

  • Study site

    Miami, Florida, 33143

  • Study site

    Middleburg Heights, Ohio, 44130

  • Study site

    Milford, Connecticut, 06460

  • Study site

    Morgantown, West Virginia, 26505

  • Study site

    Myrtle Beach, South Carolina, 29588

  • Study site

    New Windsor, New York, 12553

  • Study site

    New York, New York, 10016

  • Study site

    Newnan, Georgia, 30265

  • Study site

    Norman, Oklahoma, 73069

  • Study site

    Olive Branch, Mississippi, 38654

  • Study site

    Perrysburg, Ohio, 43551

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Pittsburgh, Pennsylvania, 15237

  • Study site

    Plant City, Florida, 33563

  • Study site

    Port Orange, Florida, 32127

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Reading, Pennsylvania, 19606

  • Study site

    Richmond, Virginia, 23235

  • Study site

    Rock Hill, South Carolina, 29732

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Seattle, Washington, 98104

  • Study site

    Sellersville, Pennsylvania, 18960

  • Study site

    South Bountiful, Utah, 84010

  • Study site

    South Traverse, Michigan, 49684

  • Study site

    Southfield, Missouri, 48034

  • Study site

    Spartanburg, South Carolina, 29303

  • Study site

    Spokane, Washington, 99208

  • Study site

    Spring Hill, Tennessee, 37174

  • Study site

    Suffolk, Virginia, 23435

  • Study site

    Tampa, Florida, 33607

  • Study site

    Trumbull, Connecticut, 06611

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Victoria, Texas, 77901

  • Study site

    Washington, Missouri, 63090

  • Study site

    West Jordon, Utah, 84088

  • Study site

    West Layton, Utah, 84041

  • Study site

    Willoughby Hills, Ohio, 44904

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winter Haven, Florida, 33880

Other trials in United States

Canada8 sites

  • Study site

    Coquitiam, British Columbia, V3K 3P4

  • Study site

    Coquitlam, British Columbia, V3K 3P4

  • Study site

    London, Ontario, N6A 5R8

  • Study site

    Mississauga, Ontario, L5M 2V8

  • Study site

    Québec, Quebec, G1V 3M7

  • Study site

    Rimouski, Quebec, G5L 8W1

  • Study site

    Toronto, Ontario, M9W 4L6

  • Study site

    Victoria, British Columbia, V8V 3N7

Other trials in Canada

Belgium5 sites

  • Study site

    Anderlecht, Brussels Capital, 1070

  • Study site

    Genk, Limburg, 3600

  • Study site

    Gozée, 6534

  • Study site

    Kortrijk, 8500

  • Study site

    Yvoir, 5530

Other trials in Belgium

South Africa5 sites

  • Study site

    Durban, 4092

  • Study site

    Pretoria, 0002

  • Study site

    Rondebosch, 7700

  • Study site

    Stellenbosch, 7600

  • Study site

    Thabazimbi, 0380

Other trials in South Africa

Australia3 sites

  • Study site

    Butterfield, Queensland, 4029

  • Study site

    Hobart, Tasmania, 7000

  • Study site

    Tasmania, 7000

Other trials in Australia

Germany3 sites

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Dresden, 01069

  • Study site

    Leipzig, Saxony, 04109

Other trials in Germany

New Zealand3 sites

  • Study site

    Auckland, 1010

  • Study site

    Auckland, 1023

  • Study site

    Tauranga, Bay of Plenty, 3143

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.

Conditions
Gout
Being tested
lesinurad, Placebo
Keywords
Gout
Medical subject headings
Gout

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lesinuradDrug

    Tablets, 400 mg QD

  • PlaceboDrug

    Tablets, Placebo QD

Study groups in NCT01508702
Study groupRoleWhat they receive
lesinurad 400 mgExperimentalNot described
Receives: Drug: lesinurad
placeboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionOct 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01508702
Sponsor's protocol ID
RDEA594-303
Other IDs
2011-003756-39
Acronym
LIGHT
Status last verified
Jul 2015
First submitted
10 Jan 2012
Last updated
12 Feb 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35835008

  • 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.

    PubMed 29029210

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lesinurad in people with Gout, run by Ardea Biosciences, Inc. at 106 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, Canada, Belgium, South Africa, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With an sUA Level That is < 6.0 mg/dL (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01508702, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in