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Lesinurad and Febuxostat Combination Extension Study in Gout

Primary Purpose

Gout

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lesinurad
lesinurad
febuxostat
Sponsored by
Ardea Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring Gout

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

lesinurad 400 mg + febuxostat 80 mg

lesinurad 200 mg + febuxostat 80 mg

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus
Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)

Full Information

First Posted
March 7, 2013
Last Updated
January 3, 2018
Sponsor
Ardea Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01808144
Brief Title
Lesinurad and Febuxostat Combination Extension Study in Gout
Official Title
A Long-Term Extension Study of Lesinurad in Combination With Febuxostat for Subjects With Gout Completing an Efficacy and Safety Study of Lesinurad and Febuxostat
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
August 9, 2016 (Actual)
Study Completion Date
October 6, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardea Biosciences, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lesinurad 400 mg + febuxostat 80 mg
Arm Type
Experimental
Arm Description
Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.
Arm Title
lesinurad 200 mg + febuxostat 80 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lesinurad
Intervention Description
Tablets, 400 mg once daily (QD)
Intervention Type
Drug
Intervention Name(s)
lesinurad
Intervention Description
Tablets, 200 mg QD
Intervention Type
Drug
Intervention Name(s)
febuxostat
Intervention Description
Tabletsm 80 mg QD
Primary Outcome Measure Information:
Title
Percentage of Participants With an sUA Level That is < 5.0 mg/dL
Description
Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
Time Frame
Up to approximately 2.5 years (at Extension Month 12)
Secondary Outcome Measure Information:
Title
Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus
Description
Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)
Time Frame
Up to approximatley 2.5 years (at Extension Month 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nihar Bhakta, MD
Organizational Affiliation
Ardea Biosciences, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
City
Johns Creek
State/Province
Georgia
ZIP/Postal Code
30097
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
City
Elizabethtown
State/Province
Kentucky
ZIP/Postal Code
42701
Country
United States
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Belle Vernon
State/Province
Pennsylvania
ZIP/Postal Code
15012
Country
United States
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75218
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W4L6
Country
Canada
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
City
Tauranga
ZIP/Postal Code
3143
Country
New Zealand
City
Kutno
State/Province
Iodzkie
ZIP/Postal Code
99-300
Country
Poland
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-430
Country
Poland
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-954
Country
Poland
City
Konskie
State/Province
Swietokrzyskie
ZIP/Postal Code
26-200
Country
Poland
City
Elblag
State/Province
Warminsko-Mazurskie
ZIP/Postal Code
82-300
Country
Poland
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-773
Country
Poland
City
Fribourg
ZIP/Postal Code
1705
Country
Switzerland
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Lesinurad and Febuxostat Combination Extension Study in Gout

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