This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
116
Participants received VX-659/TEZ/IVA orally once daily in the morning.
Participants received TEZ/IVA orally once daily in the morning.
Participants received IVA orally once daily in the evening.
Absolute Change 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.
Time frame: From Baseline at Week 4
Absolute Change in Sweat Chloride (SwCl)
Sweat samples were collected using an approved collection device.
Time frame: From Baseline at Week 4
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Time frame: From Baseline at Week 4
Safety and Tolerability as Assessed Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to Week 8)
Observed Pre-Dose Concentration (Ctrough) of VX-659, TEZ, TEZ Metabolite (M1-TEZ), and IVA
Time frame: From Day 1 and Week 4
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Participants received placebo matched TEZ/IVA orally once daily in the morning.
Participants received placebo matched to VX-659/TEZ/IVA orally once daily in the morning.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Yale New Haven Medical Center
New Haven, Connecticut, United States
University of Miami/Miller School of Medicine
Miami, Florida, United States
St. Luke's CF Center of Idaho
Boise, Idaho, United States
Advocate Children's Hospital- Park Ridge/ North Suburban Pulmonary and Critical Care Consultants
Niles, Illinois, United States
Indiana Clinical Research Center, IU Health University Hospital
Indianapolis, Indiana, United States
The University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Helen DeVos Children's Hospital CF Center
Grand Rapids, Michigan, United States
...and 36 more locations