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New mRNA inhalation therapy offers hope for Hard-to-Treat cystic fibrosis

NCT ID NCT05668741

First seen Nov 01, 2025 · Last updated Jun 22, 2026 · Updated 40 times

Summary

This early-stage trial tests an inhaled mRNA therapy called VX-522, combined with an existing drug (ivacaftor), in 26 adults with cystic fibrosis who have genetic mutations that do not respond to current modulator treatments. The main goals are to check safety and tolerability, and to see if it can improve lung function. Participants must have stable disease and specific CFTR gene mutations.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough

    Penarth, United Kingdom

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Clinical & Translational Science Unit (CTSU) - Pulmonology

    Kansas City, Kansas, 66160, United States

  • IUCPQ Pavillon Recherche U-1771

    Québec, Canada

  • Karolinska University Hospital - Pulmonology

    Stockholm, Sweden

  • MGH - MGfC Pediatric Cystic Fibrosis Center

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina - Pulmonology

    Charleston, South Carolina, 29425, 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, 90806, United States

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • PAREXEL International - Baltimore

    Baltimore, Maryland, 21225, United States

  • Papworth Hospital NHS Foundation Trust

    Cambridge, United Kingdom

  • Queen Elizabeth University Hospital - Pulmonology

    Glasgow, United Kingdom

  • Royal Brompton Hospital

    London, United Kingdom

  • Ruhrlandklinik

    Essen, Germany

  • St. Louis Children's Hospital - Pulmonology

    St Louis, Missouri, 63110, United States

  • Stanford University - Palo Alto - Pulmonology

    Palo Alto, California, 94304, United States

  • The Alfred Hospital - Pulmonology

    Melbourne, Australia

  • The Johns Hopkins University - Johns Hopkins Hospital - Pulmonology

    Baltimore, Maryland, 21287, United States

  • UC Health Holmes Hospital

    Cincinnati, Ohio, 45220, United States

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • University Hospital Southampton NHS Fountion - Southampton General Hospital

    Southampton, United Kingdom

  • University of Alabama at Birmingham - Child Health Research Unit

    Birmingham, Alabama, 35233, United States

  • University of Calgary Medical Clinic of the Foothills Medical Centre

    Calgary, Canada

  • University of Minnesota -Pulmonology

    Minneapolis, Minnesota, 55455, United States

  • University of Utah Hospital - Pulmonology

    Salt Lake City, Utah, 84132, United States

  • Wythenshawe Hospital - OPD

    Manchester, United Kingdom

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

VX-522 mRNA therapy (inhaled) plus ivacaftor tablet

What this could lead to

If successful, this could provide a new treatment option for people with cystic fibrosis who cannot use current modulator therapies, potentially improving lung function and quality of life.

What could go wrong

This is an early-phase trial with only 26 participants, so safety and effectiveness are not yet proven. The therapy is inhaled, which may cause side effects, and it requires ongoing use of ivacaftor.

Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.