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Restore CFTR Protein Closed to Enrollment

Study to evaluate SION-719 in adults with cystic fibrosis who are already taking Trikafta® and have two copies of the F508del mutation. (Sionna Phase 2a SION-719-201 (PreciSION CF))

This study will evaluate SION-719 for safety and tolerability, as well as how the body processes it. The drug is intended to help CFTR function closer to normal, when given to adults with CF who are already taking Trikafta.

 

This is a placebo controlled crossover study. During the first portion of the study, half of the participants will receive SION-719 and the other half will receive a placebo. Then in the second portion of the study, participants will cross over and receive what they didn’t have – either a placebo or SION-719. Participants and study staff will not know which treatment will be assigned first. Researchers will measure safety and tolerability by monitoring for adverse events. They will also track how the body processes SION-719 and how much of the drug is in the blood.

This study may require lung function tests, blood draws, sweat tests, and/or other measurements.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years to 65 Years

  • Mutation(s):

    Two Copies F508del

  • FEV1% Predicted:

    40% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Participants will have two copies of F508 del and must be stable on Trikafta.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    16 weeks

  • Number of Study Visits:

    6

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Sionna

  • Study Drugs:

    SION-719

Study Sites

  • Closed to Enrollment

    Arizona

    Phoenix Children's Hospital, Phoenix, AZ 85016

  • Closed to Enrollment

    Colorado

    National Jewish Health, Denver, CO 80206

  • Closed to Enrollment

    Iowa

    University of Iowa, Iowa City, IA 52242

  • Closed to Enrollment

    Maryland

    Johns Hopkins University, Baltimore, MD 21205

  • Closed to Enrollment

    Massachusetts

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

  • Closed to Enrollment

    Missouri

    Washington University School of Medicine, St. Louis, MO 63110

  • Closed to Enrollment

    New York

    Columbia University Cystic Fibrosis Program, New York, NY 10032

  • Closed to Enrollment

    New York

    New York Medical College at Westchester Medical Center, Valhalla, NY 10595

  • Closed to Enrollment

    Ohio

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

  • Closed to Enrollment

    South Carolina

    Medical University of South Carolina, Charleston, SC 29425

  • Closed to Enrollment

    Washington

    University of Washington Medical Center, Seattle, WA 98195

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years to 65 Years

  • Mutation(s):

    Two Copies F508del

  • FEV1% Predicted:

    40% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Participants will have two copies of F508 del and must be stable on Trikafta.

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