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Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Restore CFTR Function

Trial status

Closed to recruitment - in follow up

Participating Centres
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

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 (F508del/MF).

Trial Reference Number


Trial type


Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment

20 weeks

the name of the treatment or therapy being researched

CFTR Modulators

Recruitment target
the number of participants who need to be recruited for the trial in the UK


Last edited date

20 November 2017

CF sponsor

Vertex Pharmaceuticals Incorporated

CF sponsor type


Who can take part?


13 - 17

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

CF centres running this trial


Heart of England NHS Foundation Trust


Birmingham Heartlands Hospital Bordesley Green East Birmingham West Midlands B9 5SS

Recruitment starts

February 2017

Recruitment ends

August 2017


Nash, Edward

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Royal Brompton and Harefield NHS Foundation Trust


Royal Brompton Hospital Sydney Street London Greater London SW3 6NP

Recruitment starts

February 2017

Recruitment ends

December 2017


Davies, Jane C

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Southampton General Hospital


Tremona Road Southampton Hampshire SO16 6YD

Recruitment starts

February 2017

Recruitment ends

November 2017


Carroll, Mary

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