At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 307 enrolled
Drug / intervention
ELX/TEZ/IVA +3 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 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation
In Brief
A Phase 3 clinical trial evaluating ELX/TEZ/IVA, IVA, and 2 other interventions for Cystic Fibrosis. Completed, enrolled 307 participants across 90 sites in 15 countries.
Detailed Summary
This study evaluated the efficacy, pharmacodynamics (PD) and safety of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustria, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedMar 2022
Enrollment StartMay 2022
Primary CompletionJul 2023
TodayJul 2026
First PostedMar 10, 2022
Enrollment StartMay 9, 2022
Primary CompletionJul 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.3 years ago
Interventions
ELX/TEZ/IVAdrug
Fixed-dose combination (FDC) tablets for oral administration.
IVAdrug
Tablet for oral administration.
Placebo (matched to ELX/TEZ/IVA)other
Placebo matched to ELX/TEZ/IVA for oral administration.
Placebo (matched to IVA)other
Placebo matched to IVA for oral administration.