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A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)
Sponsor: Vertex Pharmaceuticals Incorporated
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.
Official title: A Phase 1/2 Dose Escalation Study Evaluating the Safety, and Tolerability and Efficacy of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
26
Start Date
2023-02-27
Completion Date
2026-09-09
Last Updated
2026-05-22
Healthy Volunteers
No
Conditions
Interventions
VX-522 mRNA therapy
Oral inhalation using nebulizer.
IVA
Tablet for oral administration.
Locations (26)
University of Alabama at Birmingham - Child Health Research Unit
Birmingham, Alabama, United States
Memorial Health Services on behalf of Long Beach Memorial Medical Center d/b/a Miller Children's Hospital Long Beach
Long Beach, California, United States
Stanford University - Palo Alto - Pulmonology
Palo Alto, California, United States
National Jewish Health
Denver, Colorado, United States
Clinical & Translational Science Unit (CTSU) - Pulmonology
Kansas City, Kansas, United States
PAREXEL International - Baltimore
Baltimore, Maryland, United States
The Johns Hopkins University - Johns Hopkins Hospital - Pulmonology
Baltimore, Maryland, United States
MGH - MGfC Pediatric Cystic Fibrosis Center
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Minnesota -Pulmonology
Minneapolis, Minnesota, United States
St. Louis Children's Hospital - Pulmonology
St Louis, Missouri, United States
UC Health Holmes Hospital
Cincinnati, Ohio, United States
Medical University of South Carolina - Pulmonology
Charleston, South Carolina, United States
University of Utah Hospital - Pulmonology
Salt Lake City, Utah, United States
The Alfred Hospital - Pulmonology
Melbourne, Australia
Universitair Ziekenhuis Gent
Ghent, Belgium
University of Calgary Medical Clinic of the Foothills Medical Centre
Calgary, Canada
IUCPQ Pavillon Recherche U-1771
Québec, Canada
Ruhrlandklinik
Essen, Germany
Karolinska University Hospital - Pulmonology
Stockholm, Sweden
Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
Queen Elizabeth University Hospital - Pulmonology
Glasgow, United Kingdom
Royal Brompton Hospital
London, United Kingdom
Wythenshawe Hospital - OPD
Manchester, United Kingdom
All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough
Penarth, United Kingdom
University Hospital Southampton NHS Fountion - Southampton General Hospital
Southampton, United Kingdom