At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating VX-659, TEZ/IVA, and 5 other interventions for Cystic Fibrosis. Completed, enrolled 124 participants across 47 sites in 4 countries.
Detailed Summary
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).
Study Details
Timeline
Interventions
Tablet for oral administration.
TEZ/IVA fixed-dose combination tablet for oral administration.
Tablet for oral administration.
Placebo matched to VX-659 and TEZ/IVA.
Tablet for oral administration.
Tablet for oral administration.
Placebo matched to VX-659, TEZ and VX-561.