Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors



Status:Completed
Conditions:Gout
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:January 2012
End Date:November 2013

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
75
sites
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Brentwood, TN
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Butterfield,
Click here to add this to my saved trials
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Covina, CA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Elizabethtown, KY
Click here to add this to my saved trials
?
mi
from
Englewood, CO
Click here to add this to my saved trials
?
mi
from
Fargo, ND
Click here to add this to my saved trials
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
?
mi
from
Hartsdale, NY
Click here to add this to my saved trials
?
mi
from
Hickory, NC
Click here to add this to my saved trials
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington Park, California 90255
?
mi
from
Huntington Park, CA
Click here to add this to my saved trials
?
mi
from
Irvine, CA
Click here to add this to my saved trials
?
mi
from
Jackson, MS
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jenkintown, PA
Click here to add this to my saved trials
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
?
mi
from
Lansdale, PA
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Meridian, ID
Click here to add this to my saved trials
?
mi
from
Metairie, LA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Middleburgh Heights, Ohio 44130
?
mi
from
Middleburgh Heights, OH
Click here to add this to my saved trials
?
mi
from
Milford, CT
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
?
mi
from
New Windsor, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newman, GA
Click here to add this to my saved trials
?
mi
from
Norman, OK
Click here to add this to my saved trials
Olive Branch, Mississippi 38654
?
mi
from
Olive Branch, MS
Click here to add this to my saved trials
?
mi
from
Perrysburgh, OH
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Plant City, FL
Click here to add this to my saved trials
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Reading, PA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Rock Hill, SC
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Sellersville, Pennsylvania 18960
?
mi
from
Sellersville, PA
Click here to add this to my saved trials
?
mi
from
South Bountiful, UT
Click here to add this to my saved trials
?
mi
from
South Traverse, MI
Click here to add this to my saved trials
?
mi
from
Southfield, MO
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Spring Hill, TN
Click here to add this to my saved trials
?
mi
from
Suffolk, VA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Trumbull, CT
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Victoria, TX
Click here to add this to my saved trials
?
mi
from
Washington, MO
Click here to add this to my saved trials
?
mi
from
West Jordon, UT
Click here to add this to my saved trials
?
mi
from
West Layton, UT
Click here to add this to my saved trials
?
mi
from
Willoughby Hills, OH
Click here to add this to my saved trials
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
?
mi
from
Winter Haven, FL
Click here to add this to my saved trials