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NCT05422222 · ClinicalTrials.gov registry record · Phase 3
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
A Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 210
- Enrollment target
- 20
- Study locations
NCT05422222: Recruiting Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
NCT05422222 is a Phase 3 study of Cystic Fibrosis that is actively recruiting participants, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 210 participants, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (18% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05422222, a Phase 3 study of Cystic Fibrosis, is actively recruiting participants, sponsored by Vertex Pharmaceuticals Incorporated.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 210 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Conditions Studied
Interventions
- DRUG VX-121/TEZ/D-IVA
Study Locations (20)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center - Cleveland
- Nationwide Children's Hospital - Columbus
California
- Children's Hospital of Orange County - Orange
- Stanford University Clinical and Translational Research Unit - Palo Alto
Missouri
- The Children's Mercy Hospital - Kansas City
- Washington University School of Medicine / St. Louis Children's Hospital - St Louis
Colorado
- Children's Hospital of Colorado - Aurora
Georgia
- The Emory Clinic / Children's Healthcare of Atlanta at Egleston - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Indiana
- Riley Hospital for Children at Indiana University Health - Indianapolis
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2022-06-21 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 3 |
What NCT05422222 shows while recruiting
NCT05422222 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (18% higher).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which VX-121/TEZ/D-IVA is the first listed.
NCT05422222 names 20 study sites across 16 states, led by Ohio, California, Missouri.
Frequently Asked Questions
What is clinical trial NCT05422222 about?
NCT05422222 is a clinical study titled "Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age". The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gen...
What is the current status of trial NCT05422222?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2022-06-21. Estimated completion is 2030-06-30.
What conditions does trial NCT05422222 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT05422222?
The interventions under investigation include: VX-121/TEZ/D-IVA (DRUG).
Who is sponsoring clinical trial NCT05422222?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05422222 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05422222's enrollment target sits among peer trials
210 34th of 169 higher than 135 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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