Lesinurad and Febuxostat Combination Extension Study in Gout

• ClinicalTrials.gov Identifier: NCT01808144
• Recruitment Status: Completed
• First Posted: March 11, 2013
• Results First Posted: January 30, 2018
• Last Update Posted: January 30, 2018
• Sponsor: Ardea Biosciences, Inc.
• Information provided by (Responsible Party): Ardea Biosciences, Inc.

Tracking Information

• First Submitted Date: March 7, 2013
• First Posted Date: March 11, 2013
• Results First Submitted Date: August 21, 2017
• Results First Posted Date: January 30, 2018
• Last Update Posted Date: January 30, 2018
• Actual Study Start Date: March 1, 2013
• Actual Primary Completion Date: August 9, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 3, 2018)

Percentage of Participants With an sUA Level That is < 5.0 mg/dL [ Time Frame: Up to approximately 2.5 years (at Extension Month 12) ]

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

• Original Primary Outcome Measures (submitted: March 7, 2013): Proportion of subjects with an sUA level that is < 5.0 mg/dL [ Time Frame: Up to approximately 2.5 years ]

Current Secondary Outcome Measures (submitted: January 3, 2018)

Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus [ Time Frame: Up to approximatley 2.5 years (at Extension Month 12) ]

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)

• Original Secondary Outcome Measures (submitted: March 7, 2013): Resolution of at least 1 target tophi [ Time Frame: Up to Month 12 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures (submitted: March 7, 2013): Incidence of treatment emergent adverse events [ Time Frame: Up to approximately 2.5 years ]

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Gout

Intervention

• Drug: lesinurad
  Tablets, 400 mg once daily (QD)
• Drug: lesinurad
  Tablets, 200 mg QD
• Drug: febuxostat
  Tabletsm 80 mg QD

Study Arms

• Experimental: lesinurad 400 mg + febuxostat 80 mg
  Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 3, dated 07 October 2015.
  Interventions:

  • Drug: lesinurad
  • Drug: febuxostat
• Experimental: lesinurad 200 mg + febuxostat 80 mg
  Interventions:

  • Drug: lesinurad
  • Drug: febuxostat

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 23, 2017): 196
• Original Estimated Enrollment (submitted: March 7, 2013): 200
• Actual Study Completion Date: October 6, 2016
• Actual Primary Completion Date: August 9, 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, New Zealand, Poland, Switzerland, United States

Administrative Information

• NCT Number: NCT01808144
• Other Study ID Numbers: RDEA594-307; 2012-004390-54 ( EudraCT Number )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ardea Biosciences, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Ardea Biosciences, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Nihar Bhakta, MD; Ardea Biosciences, Inc.

• PRS Account: Ardea Biosciences, Inc.
• Verification Date: January 2018