Lesinurad and Febuxostat Combination Extension Study in Gout

Overview

This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 9, 2016

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • Experimental: lesinurad 200 mg + febuxostat 80 mg

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ardea Biosciences, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Nihar Bhakta, MD, Study Director, Ardea Biosciences, Inc.

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