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NCT05444257 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
A Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Active
- Registry status
- Phase 3
- Development phase
- 822
- Enrollment target
- 20
- Study locations
NCT05444257: Active Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
NCT05444257 is a Phase 3 study of Cystic Fibrosis that is active but no longer recruiting, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 822 participants, above the 174-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (372% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05444257, a Phase 3 study of Cystic Fibrosis, is active but no longer recruiting, sponsored by Vertex Pharmaceuticals Incorporated.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 822 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Conditions Studied
Interventions
- DRUG VX-121/TEZ/D-IVA
Study Locations (20)
Florida
- University of Florida, Shands Hospital - Gainesville
- Joe DiMaggio Cystic Fibrosis & Pulmonary Center - Hollywood
- University of Miami Miller School of Medicine - Miami
- Central Florida Pulmonary Group,PA - Orlando
- Nemours Children's Specialty Care - Pensacola
- Johns Hopkins All Children's Hospital Outpatient Care Center - St. Petersburg
California
- Miller Children's Hospital / Long Beach Memorial - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Kaiser Permanente - Oakland
- University of California Davis Medical Center - Sacramento
- University of California San Francisco, Lung Transplant Program - San Francisco
Colorado
- Children's Hospital of Colorado - Aurora
- National Jewish Health - Denver
Georgia
- The Emory Clinic at Chantilly - Atlanta
- Augusta University - Augusta
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Banner University of Arizona Medical Center - Tucson
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Idaho
- St. Luke's Cystic Fibrosis Center of Idaho - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 822 participants |
| Start Date | 2022-11-08 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 3 |
What the registry record for NCT05444257 still lists
NCT05444257 is an interventional study that assigns participants to a tested intervention. The registered 822 participants enrollment target is mid-sized for trials with a published cap, above the 174-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (372% 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.
NCT05444257 names 20 study sites across 9 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05444257 about?
NCT05444257 is a clinical study titled "A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy". The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
What is the current status of trial NCT05444257?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 822 participants. The study started on 2022-11-08. Estimated completion is 2026-10-30.
What conditions does trial NCT05444257 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT05444257?
The interventions under investigation include: VX-121/TEZ/D-IVA (DRUG).
Who is sponsoring clinical trial NCT05444257?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05444257 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. 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 NCT05444257's enrollment target sits among peer trials
822 6th of 169 higher than 164 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.
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