A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis (VX15-440-101)
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001546
- Last updated
- 20/11/2017
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
Study detailsThis 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
- Phase
- Phase 2
- Length of participation
- 20 weeks
- Recruitment target
- 270
- CF sponsor
- Vertex Pharmaceuticals Incorporated
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 12+
- Including people
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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