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A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects with Tophaceous Gout

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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 Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects with Tophaceous Gout

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Oct 2021

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At a glance

  • Drugs Lesinurad (Primary) ; Febuxostat
  • Indications Gout; Hyperuricaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CRYSTAL
  • 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.
    • 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.
    • 17 Jun 2017 Pooled safety results from three large pivotal studies and their extensions (CRYSTAL, CLEAR-1, CLEAR-2, CRYSTAL extension and CLEAR extension), presented at the 18th Annual Congress of the European League Against Rheumatism

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