At a glance
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A Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis
In Brief
A Phase 2 clinical trial evaluating VX-152, TEZ/IVA, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 80 participants across 16 sites.
Detailed Summary
This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del).
Study Details
Timeline
Interventions
Tablet for oral administration.
Fixed-dose combination tablet for oral administration.
Tablet for oral administration.
Placebo matched to VX-152.
Placebo matched to VX-152/TEZ/IVA triple combination (TC).