At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)
In Brief
A Phase 3 clinical trial evaluating VX-121/TEZ/D-IVA, ELX/TEZ/IVA, and 4 other interventions for Cystic Fibrosis. Completed, enrolled 435 participants across 139 sites in 12 countries.
Detailed Summary
The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
Study Details
Timeline
Interventions
Fixed-dose combination tablets for oral administration.
Fixed-dose combination tablets for oral administration.
Tablet for oral administration.
Placebo matched to VX-121/TEZ/D-IVA for oral administration.
Placebo matched to ELX/TEZ/IVA for oral administration.
Placebo matched to IVA for oral administration.