A Phase 2 study of ABBV-3067 alone and in combination with ABBV-2222
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT002041
- Last updated
- 13/07/2020
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
Study detailsIn 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.
- Phase
- Phase 2
- Recruitment target
- 189
- CF sponsor
- AbbVie
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 18 years and older
- Including people
Homozygous for the F508del Mutation (2 copies of F508d)
18 Years and older
Lung function > 40 and <90%- Excluding people
Cirrhosis with portal hypertension
Use of CFTR modulator therapy within 60 days prior to Screening