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

Details

Therapeutic category
Restore CFTR Function
Trial status
Completed Participating Centres
Phase
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
82171
Trial type
Medication
Length of participation
20 weeks
Intervention
CFTR Modulators
Recruitment target
270
Last edited date
20/11/2017
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Age
12+
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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