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Restore CFTR Protein Closed to Enrollment

Study of VX-121 in people with CF ages 12 years and older who have either two copies of the F508del mutation, one copy of the F508del mutation and one copy of a gating or residual function mutation, or no copies of the F508del mutation and at least one other triple combination responsive CFTR mutation (Vertex VX20-121-103)

This study will look at the safety and effectiveness of VX-121/tezacaftor/deutivacaftor, a drug combination intended to help CFTR protein function closer to normal.

 This study will test once-a-day dosing by using an active comparator. This means that some participants will receive the study drug or a placebo in the morning, and others will receive Trikafta®(elexacaftor/tezacaftor/ivacaftor) or a placebo in the morning and ivacaftor or a placebo in the evening. Researchers will test the effectiveness of the VX-121/tezacaftor/deutivacaftor combination by measuring changes in lung function and sweat chloride.This study may require lung function tests, sweat tests, blood draws, and/or other measures.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    12 Years and Older

  • Mutation(s):

    See Other Primary Eligibility Criteria

  • 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

Study participants must have either two copies of the F508del mutation, one copy of the F508del mutation and one copy of a gating or residual function mutation, or no copies of the F508del mutation and at least one other triple combination responsive CFTR mutation. Click here to see a list of eligible mutations.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    No

  • Length of Participation:

    64 weeks

  • Number of Study Visits:

    10

Additional Information

Study Sites

  • Closed to Enrollment

    Alabama

    University of Alabama at Birmingham, Birmingham, AL 35233

  • 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

    California

    CHOC Children's Hospital, Orange, CA 92868

  • Closed to Enrollment

    California

    University of California at Davis Medical Center, Sacramento, CA 95817

  • Closed to Enrollment

    Colorado

    National Jewish Health, Denver, CO 80206

  • Closed to Enrollment

    Colorado

    Children's Hospital Colorado, Aurora, CO 80045

  • Closed to Enrollment

    Connecticut

    Yale University School of Medicine, New Haven, CT 06520

  • Closed to Enrollment

    Florida

    All Children's Hospital, St. Petersburg, FL 33701

  • Closed to Enrollment

    Florida

    Central Florida Pulmonary Group, Orlando, FL 32803

  • Closed to Enrollment

    Florida

    University of Miami, Miami, FL 33136

  • Closed to Enrollment

    Florida

    Nemours Children's Health - Pensacola, Pensacola, FL 32514

  • Closed to Enrollment

    Florida

    Nemours Children's Clinic - Jacksonville, Jacksonville, FL 32207

  • Closed to Enrollment

    Georgia

    Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30329

  • Closed to Enrollment

    Idaho

    Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702

  • Closed to Enrollment

    Illinois

    Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL 60611

  • Closed to Enrollment

    Illinois

    Northwestern University, Chicago, IL 60611

  • Closed to Enrollment

    Indiana

    Riley Hospital for Children, Indianapolis, IN 46202

  • Closed to Enrollment

    Indiana

    Indiana University Medical Center, Indianapolis, IN 46202

  • Closed to Enrollment

    Kentucky

    University of Kentucky, Lexington, KY 40506

  • Closed to Enrollment

    Louisiana

    Tulane University, Metairie, LA 70006

  • Closed to Enrollment

    Maine

    MaineHealth Pediatric Specialty Care, Portland, ME 04102

  • Closed to Enrollment

    Massachusetts

    Massachusetts General Hospital, Boston, MA 02114

  • Closed to Enrollment

    Massachusetts

    University of Massachusetts Memorial Health Care, Worcester, MA 01655

  • Closed to Enrollment

    Massachusetts

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

  • Closed to Enrollment

    Michigan

    University of Michigan, Michigan Medicine, Ann Arbor, MI 48109

  • Closed to Enrollment

    Michigan

    Corewell Health, Grand Rapids, MI 49546

  • 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

    Missouri

    Children's Mercy Kansas City, Kansas City, MO 64108

  • Closed to Enrollment

    Montana

    Billings Clinic , Billings, MT 59101

  • Closed to Enrollment

    New Jersey

    Morristown Medical Center , Morristown, NJ 07960

  • Closed to Enrollment

    New York

    The Cystic Fibrosis Center of Western New York, Buffalo, NY 14203

  • Closed to Enrollment

    New York

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

  • Closed to Enrollment

    New York

    Columbia University Cystic Fibrosis Program, New York, NY 10032

  • Closed to Enrollment

    New York

    SUNY Upstate Medical University, Syracuse, NY 13210

  • Closed to Enrollment

    North Carolina

    Atrium Health Wake Forest Baptist, Winston-Salem, NC 27157

  • Closed to Enrollment

    Ohio

    Dayton Children's Hospital, Dayton, OH 45404

  • Closed to Enrollment

    Ohio

    Toledo Children's Hospital, Toledo, OH 43606

  • Closed to Enrollment

    Ohio

    Children's Hospital Medical Center of Akron, Akron, OH 44308

  • Closed to Enrollment

    Ohio

    Nationwide Children's Hospital, Columbus, OH 43205

  • Closed to Enrollment

    Oklahoma

    Oklahoma Cystic Fibrosis Center, OKC, OK 73104

  • Closed to Enrollment

    Oregon

    Oregon Health & Science University, Portland, OR 97239

  • Closed to Enrollment

    Pennsylvania

    Children's Hospital of Philadelphia, Philadelphia, PA 19104

  • Closed to Enrollment

    Pennsylvania

    Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224

  • Closed to Enrollment

    South Carolina

    Prisma Health Children's Hospital - Midlands, Columbia, SC 29203

  • Closed to Enrollment

    South Dakota

    Sanford USD Medical Center, Sioux Falls, SD 57117

  • Closed to Enrollment

    Tennessee

    Vanderbilt University Medical Center, Nashville, TN 37232

  • Closed to Enrollment

    Texas

    Cook Children's Medical Center, Fort Worth, TX 76104

  • Closed to Enrollment

    Texas

    University of Texas Southwestern, Dallas, TX 75390

  • Closed to Enrollment

    Utah

    Primary Children's Cystic Fibrosis Center, Salt Lake City, UT 84113

  • Closed to Enrollment

    Vermont

    University of Vermont Medical Center, Burlington, VT 05401

  • Closed to Enrollment

    Virginia

    University of Virginia, Charlottesville, VA 22903

  • Closed to Enrollment

    Washington

    Providence Medical Group, Cystic Fibrosis Clinic, Spokane, WA 99204

  • Closed to Enrollment

    Washington

    University of Washington Medical Center, Seattle, WA 98195

  • Closed to Enrollment

    West Virginia

    West Virginia University - Morgantown, Morgantown, WV 26507

  • Closed to Enrollment

    Wisconsin

    University of Wisconsin, Madison, WI 53792

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    12 Years and Older

  • Mutation(s):

    See Other Primary Eligibility Criteria

  • 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

Study participants must have either two copies of the F508del mutation, one copy of the F508del mutation and one copy of a gating or residual function mutation, or no copies of the F508del mutation and at least one other triple combination responsive CFTR mutation. Click here to see a list of eligible mutations.

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