A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis
A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis
This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).
Key Inclusion Criteria:
Body weight ≥35 kg.
Subjects must have an eligibleCFTR genotype.
FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
Morton Grove, Illinois 60053, United States
Baltimore, Maryland 21287, United States
New Brunswick, New Jersey 08902, United States
Pittsburgh, Pennsylvania 15224, United States
Knoxville, Tennessee 37920, United States
Memphis, Tennessee 38103, United States
Tikvah, Israel
Devon, United Kingdom
Fulham, United Kingdom
Hampshire, United Kingdom
Merseyside, United Kingdom