This is a multicenter, multi-country, Phase 2, three parallel-cohort study of galicaftor, navocaftor, and ABBV-119 or ABBV-576 combination therapy for 28 days in adult CF subjects who are homozygous or heterozygous for the F508del mutation, including subjects already on stable CFTR modulator therapy. This study is designed as a proof-of-concept study to evaluate the safety, tolerability, target engagement, and efficacy for galicaftor/navocaftor/ABBV-119 and galicaftor/navocaftor/ABBV-576 combination therapies administered at fixed doses. Cohort 3, the only cohort that our site is participating in for this study, is for those homozygous for F508del mutation, where this mutation is present on both copies of the CFTR gene; or heterozygous for the F508del mutation, where the F508del mutation is only present in one copy of the CFTR gene, and the other copy of the CFTR gene carries another mutation that is different from F508del. Cohort 3 is open label, meaning there is no placebo and both the patient and the study doctor will know what study treatment and what dose you are receiving. Approximately 40 subjects will be enrolled in Cohort 3, 20 subjects who are homozygous for the F508del mutation and up to 20 subjects who are heterozygous for the F508del mutation.

This is a cross-sectional, multi-center study comparing stool-based testing (multi-target DNA-based test and quantitative FIT test) to standard of care colonoscopy for CRC screening in PwCF. The study includes an enrollment visit, two stool samples completed at home, a clinical screening colonoscopy, and three participant surveys which will be completed at enrollment and remotely.
The total duration of participant participation will be 3-12 months, depending on the timing of the completion of the stool sample and the participant's colonoscopy. The targeted participant timeline is 3 months from enrollment to the completion of a clinical screening colonoscopy. To allow for varying site-specific clinical colonoscopy scheduling delays and COVID delays in scheduling, the duration of time between stool sampling and screening colonoscopy may extend up to 12 months for inclusion of data in the study. However, greater than 3 months duration between stool-based testing and colonoscopy will be considered a protocol deviation.

The primary objective of this platform trial is to evaluate the efficacy and safety of differing treatments in CF pulmonary exacerbations during a planned 14 day course of IV antimicrobials. Primary efficacy will be evaluated as the difference in mean ppFEV1 (pulmonary function testing) changes from Visit 1 to Visit 2 (Day 28 ± 2 days) between intervention arms. The study will compare treatment of an intravenous aminoglycoside and β-lactams (AG) versus intravenous β-lactams only (non-AG) in people with CF diagnosed with a pulmonary exacerbation who will be treated for Pa.