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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, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)

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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, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Ivacaftor/tezacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals

Most Recent Events

  • 13 Sep 2016 This trial was completed in Germany (end date: 12-08-2016), according to European Clinical Trials Database.
  • 13 Sep 2016 This trial was completed in Spain (end date: 27-05-2016), according European Clinical Trials Database.
  • 15 Aug 2016 Based on the futility analysis, the DSMB recommended that Vertex stop the study and not initiate enrollment in Part B as the FDC did not result in a pre-specified improvement in lung function. Company plans to file an NDA to the FDA for VX-661/ivacaftor in the H2 of 2017."

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