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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
39
Start Date
2023-02-27
Completion Date
2027-05-12
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
VX-522 mRNA therapy
Oral inhalation using nebulizer.
IVA
Tablet for oral administration.
Locations (43)
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
Shands Hospital - Pulmonology
Gainesville, Florida, United States
Northwestern Memorial Hospital - Feinberg Pavilion
Chicago, Illinois, 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
Medicine at East 85th Street
New York, New York, United States
Presbyterian Hospital - Pulmonology
New York, New York, United States
UC Health Holmes Hospital
Cincinnati, Ohio, United States
UH Cleveland Medical Center - Pulmonology
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Pittsburgh - Pulmonology
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina - Pulmonology
Charleston, South Carolina, United States
Vanderbilt Interventional Pulmonology
Nashville, Tennessee, United States
Texas Children's Hospital - Wallace Tower - Pulmonology
Houston, Texas, United States
University of Utah Hospital - Pulmonology
Salt Lake City, Utah, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 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
IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico - Pulmonology
Genova, Italy
IRCSS Ospedale Pediatrico Bambino Gesu - Pulmonology
Rome, Italy
Centro Ricerche Cliniche di Verona S.r.l.
Verona, Italy
UMCU - Department of Pulmonology and Tuberculosis
Utrecht, Netherlands
Hospital Universitari Vall d´Hebron Servicio de Broncoscopia
Barcelona, Spain
Hospital Virgen del Rocio - Pulmonology
Seville, Spain
Hospital Universitario y Politecnico La Fe - Pulmonology
Valencia, Spain
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