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: 21 Aug 2017

At a glance

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

    • 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
    • 09 Jun 2017 Results published in the Arthritis and Rheumatology
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