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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 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.

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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

Cystic Fibrosis

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

FieldValue
Enrollment Target 210 participants
Start Date 2022-06-21
Est. Completion 2030-06-30
Phase Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05422222

The ClinicalTrials.gov registry entry for NCT05422222 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (18% 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.

NCT05422222 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.

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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.