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A Phase 2 study of ABBV-3067 alone and in combination with ABBV-2222


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

Open to recruitment

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 study of ABBV-3067 alone and in combination with ABBV-2222 in Cystic Fibrosis subjects who are homozygous for the F508del mutation.

In this study, participants will be given ABBV-3067 (“potentiator”) and ABBV-2222 (“corrector”) to see if treatment improves participants’ lung function. Different groups of participants will receive different doses, and some will receive a dummy drug (“placebo”). This study evaluates the safety and efficacy (how well the medications work) of the medications and the best dose of each medicine to be used in future studies. This is a Phase 2, double-blinded (treatment type is unknown to participants and investigators) study in people with CF who have two copies of the F508del mutation (the most common CFTR gene mutation). Participants go through a screening process (up to a month) and receive study treatment for up to a month, followed by a review, a month later. Tests done for the study include lung function tests, sweat chloride tests, blood and urine tests, and ECG. Side effects are monitored through the course of the study.

Trial Reference Number


Trial type


the name of the treatment or therapy being researched

CFTR Modulators

Last edited date

11 February 2020

CF sponsor


CF sponsor type


Who can take part?

Top inclusion criteria
  • Homozygous for the F508del Mutation
  • 18 Years and older
  • Stable pulmonary status
  • Lung function > 40 and <90%
Top exclusion criteria
  • Cirrhosis with portal hypertension
  • Use of CFTR modulator therapy within 60 days prior to Screening

CF centres running this trial


Barts Health NHS Trust


81 Commercial RoadLondon E1 1RD

Recruitment ends

March 2020

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King's College Hospital NHS Foundation Trust


Denmark Hill London SE5 9RS

Recruitment ends

March 2020


Micheal Waller

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Liverpool Heart and Chest Hospital


Thomas Drive Liverpool Merseyside L14 3PE

Recruitment starts

December 2019

Recruitment ends

March 2021


Greenwood, James

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Nottingham University Hospitals NHS Trust - City Campus


City Hospital Nottingham Nottinghamshire NG5 1PB

Recruitment ends

March 2020


Barr, Helen

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Show all participating centres