A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Trial Profile

A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Nov 2017

At a glance

  • Drugs Ivacaftor/tezacaftor (Primary) ; Ivacaftor
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms EVOLVE
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 03 Nov 2017 Results assessing the efficacy of VX 661 in combination with ivacaftor in cystic fibrosis patients aged 12 and older with two copies of the F508del mutation, were published in the New England Journal of Medicine.
    • 03 Nov 2017 Results presented in a Vertex Pharmaceuticals media release.
    • 03 Nov 2017 According to a Vertex Pharmaceuticals media release, results from this trial were presented at the 31st Annual North American Cystic Fibrosis Conference and published in the New England Journal of Medicine (NEJM).
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