This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
78
Absolute Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. Mixed-effect model with repeated measures (MMRM) was used for the analyses.
Time frame: Day 1 (Baseline) through Day 29
Absolute Change From Baseline Through Day 29 in Sweat Chloride (SwCl)
Sweat collection was performed to evaluate sweat chloride concentration. SwCl is a biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) activity. Persons with CF have higher levels of chloride in their sweat. MMRM was used for the analysis.
Time frame: Day 1 (Baseline) through Day 29
Absolute Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
FVC is the total amount of air exhaled during forced expiratory volume (FEV) test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Time frame: Day 1 (Baseline) through Day 29
Absolute Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Time frame: Day 1 (Baseline) through Day 29
Relative Change From Baseline Through Day 29 in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration and is used as a measure of lung function. MMRM was used for analyses.
Time frame: Day 1 (Baseline) through Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Capsule taken orally.
University of Arkansas /ID# 212541
Little Rock, Arkansas, United States
Tampa General Hospital /ID# 212342
Tampa, Florida, United States
University of Iowa Hospitals and Clinics /ID# 212351
Iowa City, Iowa, United States
Univ Michigan Med Ctr /ID# 212657
Ann Arbor, Michigan, United States
Cardinal Glennon Children's Hospital /ID# 212349
St Louis, Missouri, United States
Washington University-School of Medicine /ID# 212352
St Louis, Missouri, United States
Nationwide Children's Hospital /ID# 213158
Columbus, Ohio, United States
Medical University of South Carolina /ID# 212187
Charleston, South Carolina, United States
Vanderbilt University Medical Center /ID# 212353
Nashville, Tennessee, United States
University of Utah /ID# 212350
Salt Lake City, Utah, United States
...and 41 more locations
Relative Change From Baseline Through Day 29 in Forced Expiratory Flow at Mid-lung Capacity (FEF25-75)
FEF25-75 is a lung function test that is measured during spirometry, and is defined as the forced expiratory flow between 25% and 75% of vital capacity (mid-lung capacity). MMRM was used for analyses.
Time frame: Day 1 (Baseline) through Day 29
Relative Change From Baseline Through Day 29 in Forced Vital Capacity (FVC)
FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. MMRM was used for the analyses.
Time frame: Day 1 (Baseline) through Day 29