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NCT05668741 · ClinicalTrials.gov registry record · Phase 1

A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)

A Phase 1 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.

Recruiting
Registry status
Phase 1
Development phase
39
Enrollment target
20
Study locations

NCT05668741 is a Phase 1 study of Cystic Fibrosis that is actively recruiting participants, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 39 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT05668741, a Phase 1 study of Cystic Fibrosis, is actively recruiting participants, sponsored by Vertex Pharmaceuticals Incorporated.

RECRUITING
Registry status
Phase 1
Development phase
39 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.

Conditions Studied

Interventions

  • DRUG VX-522 mRNA therapy
  • DRUG IVA

Study Locations (20)

Ohio

  • UC Health Holmes Hospital - Cincinnati
  • UH Cleveland Medical Center - Pulmonology - Cleveland
  • Nationwide Children's Hospital - Columbus

California

  • Memorial Health Services on behalf of Long Beach Memorial Medical Center d/b/a Miller Children's Hospital Long Beach - Long Beach
  • Stanford University - Palo Alto - Pulmonology - Palo Alto

Maryland

  • PAREXEL International - Baltimore - Baltimore
  • The Johns Hopkins University - Johns Hopkins Hospital - Pulmonology - Baltimore

Massachusetts

  • MGH - MGfC Pediatric Cystic Fibrosis Center - Boston
  • Boston Children's Hospital - Boston

New York

  • Medicine at East 85th Street - New York
  • Presbyterian Hospital - Pulmonology - New York

Alabama

  • University of Alabama at Birmingham - Child Health Research Unit - Birmingham

Colorado

  • National Jewish Health - Denver

Florida

  • Shands Hospital - Pulmonology - Gainesville

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2023-02-27
Est. Completion 2027-05-12
Phase Phase 1

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

What the Registry Record Tells You About NCT05668741

The ClinicalTrials.gov registry entry for NCT05668741 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (78% lower). 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 2 interventions - of which VX-522 mRNA therapy is the first listed.

NCT05668741 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Ohio, California, Maryland.

Frequently Asked Questions

What is clinical trial NCT05668741 about?

NCT05668741 is a clinical study titled "A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)". The purpose of this study is to evaluate the safety, and tolerability and efficacy of VX-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (CFTR) genotype not responsive to CFTR modulator therapy.

What is the current status of trial NCT05668741?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2023-02-27. Estimated completion is 2027-05-12.

What conditions does trial NCT05668741 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT05668741?

The interventions under investigation include: VX-522 mRNA therapy (DRUG), IVA (DRUG).

Who is sponsoring clinical trial NCT05668741?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05668741 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. 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

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