CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
VX-121 +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/NCT03912233
NCT03912233Phase 2Completed

A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis

Vertex Pharmaceuticals Incorporated·interventional·Posted Apr 11, 2019·Updated Apr 20, 2023

In Brief

A Phase 2 clinical trial evaluating VX-121, TEZ, and 4 other interventions for Cystic Fibrosis. Completed, enrolled 87 participants across 26 sites in 5 countries.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesGermany, Netherlands, Portugal, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 11, 2019
Enrollment StartApr 30, 2019
Primary CompletionDec 10, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.2 years ago

Interventions

VX-121drug

Tablets for oral administration.

TEZdrug

TEZ tablet for oral administration.

VX-561drug

Tablets for oral administration.

TEZ/IVAdrug

Fixed-dose combination tablets for oral administration.

IVAdrug

Tablets for oral administration.

Placebodrug

Placebos matched to VX-121, TEZ, and VX-561 for oral administration.