CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 597 enrolled
Drug / intervention
VX-121/TEZ/D-IVA +5 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.

Search/NCT05076149
NCT05076149Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation

Vertex Pharmaceuticals Incorporated·interventional·Posted Oct 13, 2021·Updated Jun 13, 2024

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 597 participants across 170 sites in 20 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesAustralia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedOct 13, 2021
Enrollment StartOct 27, 2021
Primary CompletionMay 18, 2023
Study CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 4.7 years ago

Interventions

VX-121/TEZ/D-IVAdrug

Fixed-dose combination tablets for oral administration.

ELX/TEZ/IVAdrug

Fixed-dose combination tablets for oral administration.

IVAdrug

Tablet for oral administration.

Placebo (matched to VX-121/TEZ/D-IVA)drug

Placebo matched to VX-121/TEZ/D-IVA for oral administration.

Placebo (matched to ELX/TEZ/IVA)drug

Placebo matched to ELX/TEZ/IVA for oral administration.

Placebo (matched to IVA)drug

Placebo matched to IVA for oral administration.