NCT02951182

A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis

A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, randomized, double-blind, placebo- and active-controlled, parallel group, multicenter study to evaluate the safety, tolerability, and efficacy of VX-440 in dual and triple combination with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	TEZ
DRUG	IVA
DRUG	VX-440
DRUG	Matched Placebo

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2016-11-01
• Last updated: 2020-08-28
• Results posted: 2020-08-28

Locations

40 sites across 10 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Germany, Italy, Spain, United Kingdom