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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2017

At a glance

  • Drugs Lesinurad (Primary) ; Febuxostat
  • Indications Gout; Hyperuricaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CRYSTAL
  • Sponsors Ardea Biosciences
  • Most Recent Events

    • 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
    • 09 Jun 2017 Results published in the Arthritis and Rheumatology
    • 04 Jan 2017 According to an Ironwood Pharmaceuticals media release,the US FDA accepted for review a NDA for DUZALLO (fixed-dose combination of lesinurad and allopurinol). The FDA Prescription Drug User Fee Act (PDUFA) target action date is expected to occur in the second half of 2017. This NDA was based on clinical program supporting the ZURAMPIC NDA.
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