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Anti-Inflammatory Closed to Enrollment

Study of INS1007/brensocatib tablets in adults with CF (Insmed INS1007-211)

This study will look at the safety, tolerability, and how the body processes INS1007/brensocatib tablets, a drug intended to reduce inflammation.

 This study is placebo-controlled, meaning some participants will receive INS1007 and others will receive a placebo. Four different dose levels of the drug will be studied. The drug will be given orally once per day over 4 weeks to find the best dose. Half of the participants at each dose level will continue to take their CFTR modulators and the other half will not have been on and will not receive CFTR modulators. Researchers will assess how the body processes the drug by measuring how much of the drug stays in the body. They will also test the safety and tolerability of the drug by monitoring for adverse events. This study may require lung function tests, blood draws, and/or other measures.

Eligibility

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 90%

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

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    56 days

  • Number of Study Visits:

    8

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Insmed

  • Study Drugs:

    Brensocatib

Study Sites

  • Closed to Enrollment

    Alabama

    University of Alabama at Birmingham, Birmingham, AL 35233

  • Closed to Enrollment

    California

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

  • Closed to Enrollment

    California

    University of California San Diego, La Jolla, CA 92037

  • Closed to Enrollment

    California

    Stanford University Medical Center, Palo Alto, CA 94304

  • Closed to Enrollment

    California

    Santa Barbara Cottage Hospital, Santa Barbara, CA 93105

  • Closed to Enrollment

    California

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

  • Closed to Enrollment

    District of Columbia

    MedStar Washington Hospital Center, Washington, DC 20010

  • Closed to Enrollment

    Florida

    Central Florida Pulmonary Group, Orlando, FL 32803

  • Closed to Enrollment

    Florida

    University of Florida, Gainesville, FL 32610

  • Closed to Enrollment

    Georgia

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

  • Closed to Enrollment

    Georgia

    Augusta University, Augusta, GA 30912

  • Closed to Enrollment

    Idaho

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

  • Closed to Enrollment

    Illinois

    CF Center Chicago (Glenview, Il), Glenview, IL 60025

  • Closed to Enrollment

    Massachusetts

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

  • Closed to Enrollment

    Michigan

    University of Michigan Health System, Ann Arbor, MI 48109

  • 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

    North Carolina

    Duke University Medical Center, Durham, NC 27710

  • Closed to Enrollment

    Ohio

    Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195

  • Closed to Enrollment

    Ohio

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

  • Closed to Enrollment

    Ohio

    Nationwide Children's Hospital, Columbus, OH 43205

  • Closed to Enrollment

    Oregon

    Oregon Health & Science University, Portland, OR 97239

  • Closed to Enrollment

    Pennsylvania

    University of Pittsburgh Medical Center, Pittsburgh, PA 15224

  • 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

    Baylor College of Medicine, Houston, TX 77030

  • 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

    Utah

    Adult Cystic Fibrosis Center at the University of Utah, Salt Lake City, UT 84112

Eligibility

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 90%

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

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