A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis (VX15-440-101)


Therapeutic category
Restore CFTR Function
Trial status
Completed Participating Centres
Phase II

Full title

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

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
Trial Reference Number
Trial type
Length of participation
20 weeks
CFTR Modulators
Recruitment target
Last edited date
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type

Who can take part?

Top inclusion criteria
  • Stable CF disease as judged by the investigator
  • Sweat chloride value ≥60 mmol/L from test results obtained during screening
  • Heterozygous for F508del and a minimal function (MF) mutation known or predicted not to be responsive to TEZ and/or IVA

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