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Genetic Therapy Enrolling

Study to evaluate VX-522 in adults 18 years and older with cystic fibrosis. (Vertex VX-522-001 MAD (VX21-522-001))

This study will evaluate the safety and tolerability of VX-522, an investigational inhaled messenger RNA (mRNA), in adults with CF whose mutations are not responsive to CFTR modulator therapy.

 

This study is open label, meaning all participants will receive VX-522. Study participants will receive multiple doses of the study drug over 4 weeks and will have follow up study visits for 28 weeks. Different doses of VX-522 are being studied. The study drug will be administered through inhalation. In this study, researchers will assess for safety and tolerability by monitoring for any changes in a participant’s health. 

 

This study may require blood draws, lung function testing, electrocardiograms, and/or other measurements. 

 

For additional information about the study, visit the sponsor-developed website. This website is not managed or operated by the CF Foundation, and the Foundation is not responsible for the contents of the website. 

Learn More

Email a research coordinator to express interest in participating in this study.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years to 65 Years

  • Mutation(s):

    No Copies F508del

  • FEV1% Predicted:

    40 to 90%

For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Potential participants must have 2 CFTR mutations that are not eligible to receive CFTR modulators. Potential participants who have participated in other studies of nucleic acid therapies (e.g. RNA-base therapies) must not have used those therapies within 12 months and must have completed all required follow-up prior to participating in this study. 

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    8 months

  • Number of Study Visits:

    33

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Vertex

  • Study Drugs:

    VX-522 mRNA

Study Sites

  • Closed to Enrollment

    Alabama

    University of Alabama at Birmingham, Birmingham, AL 35233

  • Closed to Enrollment

    California

    Stanford University Medical Center, Palo Alto, CA 94304

  • Closed to Enrollment

    California

    Long Beach Memorial Medical Center, Long Beach, CA 90806

  • Closed to Enrollment

    Colorado

    National Jewish Health, Denver, CO 80206

  • Closed to Enrollment

    Florida

    University of Florida, Gainesville, FL 32610

  • Closed to Enrollment

    Illinois

    Northwestern University, Chicago, IL 60611

  • Closed to Enrollment

    Kansas

    University of Kansas Medical Center, Kansas City, KS 66160

  • Closed to Enrollment

    Maryland

    Johns Hopkins University, Baltimore, MD 21205

  • Closed to Enrollment

    Massachusetts

    Massachusetts General Hospital, Boston, MA 02114

  • Closed to Enrollment

    Massachusetts

    Boston Children's Hospital, Brigham & Women's Hospital, Boston, MA 02115

  • Closed to Enrollment

    Minnesota

    The Minnesota Cystic Fibrosis Center, Minneapolis, MN 55455

  • Closed to Enrollment

    New York

    Lenox Hill Cystic Fibrosis Center, New York, NY 10028

  • Closed to Enrollment

    Ohio

    University of Cincinnati Medical Center, Cincinnati, OH 45267

  • Closed to Enrollment

    Ohio

    Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106

  • Closed to Enrollment

    Ohio

    Nationwide Children's Hospital, Columbus, OH 43205

  • Enrolling Soon

    Pennsylvania

    University of Pittsburgh Medical Center, Pittsburgh, PA 15224

    Contact

    Adrienne DeRicco

    Phone: +1 (412) 692-8069

    Email:

  • Closed to Enrollment

    South Carolina

    Medical University of South Carolina, Charleston, SC 29425

  • Closed to Enrollment

    Tennessee

    Vanderbilt University Medical Center, Nashville, TN 37232

  • Closed to Enrollment

    Texas

    Baylor College of Medicine, Houston, TX 77030

  • Enrolling Soon

    Utah

    Adult Cystic Fibrosis Center at the University of Utah, Salt Lake City, UT 84112

    Contact

    Kristyn Packer

    Phone: +1 (801) 520-5106

    Email:

  • Closed to Enrollment

    Wisconsin

    University of Wisconsin, Madison, WI 53792

Learn More

Email a research coordinator to express interest in participating in this study.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years to 65 Years

  • Mutation(s):

    No Copies F508del

  • FEV1% Predicted:

    40 to 90%

For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Potential participants must have 2 CFTR mutations that are not eligible to receive CFTR modulators. Potential participants who have participated in other studies of nucleic acid therapies (e.g. RNA-base therapies) must not have used those therapies within 12 months and must have completed all required follow-up prior to participating in this study. 

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