NCT02508207

A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

A Phase 2, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Exploratory Study to Evaluate Effects of VX-661 in Combination With Ivacaftor on Lung and Extrapulmonary Systems in Subjects Aged 18 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661 (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Tezacaftor/Ivacaftor	Tezacaftor/Ivacaftor FDC
DRUG	Ivacaftor
DRUG	Tezacaftor/Ivacaftor matching placebo
DRUG	Ivacaftor matching placebo

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-07-24
• Last updated: 2021-07-19
• Results posted: 2018-07-27

Locations

7 sites across 1 country: United States