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
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
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
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the name of the treatment or therapy being researched
the number of participants who need to be recruited for the trial in the UK
Last edited date
01 November 2019
CF sponsor type