At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 176 enrolled
Drug / intervention
ELX/TEZ/IVA +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
In Brief
A Phase 3 clinical trial evaluating ELX/TEZ/IVA, TEZ/IVA, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 176 participants across 35 sites in 4 countries.
Detailed Summary
This study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for F508del.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Belgium, Germany, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartOct 2019
Primary CompletionJul 2020
TodayJul 2026
First PostedSep 26, 2019
Enrollment StartOct 3, 2019
Primary CompletionJul 24, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.8 years ago
Interventions
ELX/TEZ/IVAdrug
FDC tablet for oral administration.
TEZ/IVAdrug
Fixed-dose combination (FDC) tablet for oral administration.
IVAdrug
Mono tablet for oral administration.