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A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Allopurinol Compared to Allopurinol Alone in Subjects With Gout Who Have Had an Inadequate Hypouricemic Response to Standard of Care Allopurinol

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Trial Profile

A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Allopurinol Compared to Allopurinol Alone in Subjects With Gout Who Have Had an Inadequate Hypouricemic Response to Standard of Care Allopurinol

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Allopurinol/lesinurad (Primary) ; Lesinurad (Primary) ; Allopurinol
  • Indications Gout
  • Focus Registrational; Therapeutic Use
  • Acronyms CLEAR-1; CLEAR1
  • Sponsors Ardea Biosciences

    • Most Recent Events

    • 14 Aug 2018 Results of a post-hoc analysis of three (CLEAR 1 and 2; NCT01510158, NCT01493531) or febuxostat (CRYSTAL, NCT01510769) trials published in the Rheumatology.
    • 16 Jun 2018 Results of a post-hoc analysis of two trials (CLEAR 1 & CLEAR 2; n=221) assessing efficacy and safety in a subgroup of patients using concomitant diuretics, presented at the 19th Annual Congress of the European League Against Rheumatism
    • 21 Aug 2017 According to an Ironwood Pharmaceuticals media release, DUZALLO (fixed-dose combination of lesinurad and allopurinol) has been approved by the US FDA as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone. The FDA approval of DUZALLO was based on the clinical program supporting the ZURAMPIC (lesinurad) NDA and a bioequivalence study.

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