NCT02516410

A 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

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Study to evaluate the efficacy of VX-661 in combination with ivacaftor (IVA, VX-770) through Week 12 in participants with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and with a second CFTR mutation that is not likely to respond to VX-661 and/or IVA therapy (F508del/not responsive \[NR\]).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VX-661 plus ivacaftor combination
DRUG	Ivacaftor
DRUG	Placebo (matched to VX-661 plus ivacaftor combination)
DRUG	Placebo (matched to ivacaftor)

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-06-07
• Completion: 2016-06-07
• First posted: 2015-08-05
• Last updated: 2018-06-12
• Results posted: 2018-06-12

Locations

41 sites across 7 countries: United States, Australia, Austria, Canada, France, Israel, Spain