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Restore CFTR Protein Closed to Enrollment

Study of galicaftor/navocaftor/ABBV-576 combination therapy in adults with cystic fibrosis who have at least one F508del mutation and are on stable elexacaftor/tezacaftor/ivacaftor (Trikafta) treatment. (Abbvie M19-771)

This study will look at the safety and effectiveness of galicaftor/navocaftor/ABBV-576 combination therapy, a combination of CFTR modulators intended to help CFTR protein function closer to normal. This study is for adults with cystic fibrosis who have at least one F508del mutation.

  Participants in arm 4 (cohort 3) will receive the galicaftor/navocaftor/ABBV-576 triple-combination therapy once daily for 28 days. All study participants will receive the study drug; there is no placebo used in arm 4 (cohort 3) of this trial. Researchers will test the effectiveness of the study medication by measuring sweat chloride and lung function. This study may require clinic visits, blood tests, lung function tests, an assessment for side effects, and completion of questionnaires.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    Two Copies F508del or One Copy F508del

  • FEV1% Predicted:

    40 to 90%

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

Other Primary Eligibility Criteria

Participants must be willing to stop taking Trikafta before starting on Abbvie's triple combination modulator for 28 days and then the participants can resume ETI treatment after the study treatment period.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    No

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    3 months

  • Number of Study Visits:

    6

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    AbbVie

  • Study Drugs:

    N/A

Study Sites

  • Closed to Enrollment

    California

    Pediatric Diagnostic Center, Ventura, CA 93003

  • Closed to Enrollment

    California

    Center for Cystic Fibrosis at Keck Medical Center of USC, Los Angeles, CA 90033

  • 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

    Michigan

    Wayne State University Harper University Hospital, Detroit, MI 48201

  • Closed to Enrollment

    Missouri

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

  • Closed to Enrollment

    New Hampshire

    Dartmouth Hitchcock Medical Center, Lebanon, NH 03756

  • Closed to Enrollment

    New York

    Albany Medical College, Albany, NY 12208

  • Closed to Enrollment

    New York

    Long Island Jewish Medical Center, New Hyde Park, NY 11042

  • Closed to Enrollment

    New York

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

  • Closed to Enrollment

    Ohio

    Toledo Children's Hospital, Toledo, OH 43606

  • 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

    Oklahoma

    Oklahoma Cystic Fibrosis Center, OKC, OK 73104

  • Closed to Enrollment

    Pennsylvania

    Hershey Medical Center Pennsylvania State University, Hershey, PA 17033

  • Closed to Enrollment

    South Carolina

    Medical University of South Carolina, Charleston, SC 29425

  • Closed to Enrollment

    Texas

    University of Texas Southwestern, Dallas, TX 75390

  • Closed to Enrollment

    Texas

    University of Texas Health Center at Tyler, Tyler, TX 75708

  • Closed to Enrollment

    Virginia

    Virginia Commonwealth University, Richmond, VA 23298

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    Two Copies F508del or One Copy F508del

  • FEV1% Predicted:

    40 to 90%

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

Other Primary Eligibility Criteria

Participants must be willing to stop taking Trikafta before starting on Abbvie's triple combination modulator for 28 days and then the participants can resume ETI treatment after the study treatment period.

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