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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 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.

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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

Cystic Fibrosis

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

FieldValue
Enrollment Target 822 participants
Start Date 2022-11-08
Est. Completion 2026-10-30
Phase Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

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What the Registry Record Tells You About NCT05444257

The ClinicalTrials.gov registry entry for NCT05444257 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 822 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 174-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (372% higher). The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.