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A Study of CFTR modulator combinations in Subjects with Cystic Fibrosis (VX-121)


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-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis

The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis.

Trial Reference Number


Trial type


the name of the treatment or therapy being researched

CFTR Modulators in combination

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


Last edited date

16 October 2019

CF sponsor

Vertex Pharmaceuticals Incorporated

CF sponsor type


Who can take part?



Top inclusion criteria
  • Part 1: Heterozygous for F508del and an MF mutation
  • Part 2: Homozygous for F508del
  • FEV1 value ≥40% and ≤90% of the predicted mean for age, sex, and height

CF centres running this trial


Heartlands Hospital


Bordesley Green East Birmingham B9 5SS

Recruitment starts

June 2019

Recruitment ends

August 2019


Nash, Edward

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Royal Brompton Hospital


Sydney Street London SW3 6NP

Recruitment starts

May 2019

Recruitment ends

August 2019


Davies, Jane C

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The Newcastle upon Tyne Hospitals NHS Foundation Trust


Freeman Hospital Freeman Road High Heaton Newcastle upon Tyne NE7 7DN



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University Hospital Llandough


Penlan Road, Llandough, Penarth, South Glamorgan CF64 2XX

Recruitment ends

July 2019


Duckers, Jamie

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Show all participating centres