NCT02392234

A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VX-661/Ivacaftor	Fixed dose combination tablet, oral use
DRUG	Ivacaftor	Tablet, oral use
DRUG	Placebo matched to VX-661/ ivacaftor	Fixed dose combination tablet, oral use
DRUG	Placebo matched to Ivacaftor	Tablet, oral use

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-03-18
• Last updated: 2018-06-12
• Results posted: 2018-06-12

Locations

93 sites across 11 countries: United States, Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Switzerland, United Kingdom