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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2017

At a glance

  • Drugs Lesinurad (Primary) ; Allopurinol
  • Indications Gout; Hyperuricaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms CLEAR-2; CLEAR2
  • 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
    • 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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