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Genetic Therapy Closed to Enrollment

Study of ARCT-032 in adults with cystic fibrosis who are not on CFTR modulator therapy. (Arcturus ARCT-032-02 )

This study will test the safety, tolerability and effectiveness of ARCT-032, a nebulized therapy intended to deliver a new, correct copy of CFTR messenger RNA (mRNA) to cells.

This is an open label study. This means that all participants will receive the study drug. Researchers will measure safety and tolerability by monitoring for adverse events. They will track how the body processes ARCT-032 by measuring how much of the drug is in the blood.

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

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 100%

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

Other Primary Eligibility Criteria

Potential participants will either have mutations that are not eligible to receive CFTR modulator therapy or are no longer taking CFTR modulator therapy due to  intolerance or other reasons.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    20 weeks

  • Number of Study Visits:

    8

Additional Information

Study Sites

  • Closed to Enrollment

    Arizona

    Tucson Cystic Fibrosis Center, Tucson, AZ 85724

  • Closed to Enrollment

    Arkansas

    University of Arkansas for Medical Sciences, Little Rock, AR 72205

  • Closed to Enrollment

    California

    Children's Hospital of Los Angeles, Los Angeles, CA 90027

  • Closed to Enrollment

    Florida

    Joe DiMaggio Children's Hospital, Hollywood, FL 33021

  • Closed to Enrollment

    Florida

    Central Florida Pulmonary Group, Orlando, FL 32803

  • 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

    Ohio

    Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195

  • 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

    University of Texas Health Sciences Center - San Antonio, San Antonio, TX 78229

  • Closed to Enrollment

    Washington

    Seattle Children's Hospital, Seattle, WA 98115

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 100%

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

Other Primary Eligibility Criteria

Potential participants will either have mutations that are not eligible to receive CFTR modulator therapy or are no longer taking CFTR modulator therapy due to  intolerance or other reasons.

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