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RECRUITING Phase 3

Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age

NCT05422222 · View on ClinicalTrials.gov ↗

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

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

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05422222 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Ohio, California, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05422222?

The interventions under investigation include: VX-121/TEZ/D-IVA (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05422222?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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