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Restore CFTR Function Closed to Enrollment

Study of ABBV-3067 and ABBV-2222 in adults with cystic fibrosis who have two copies of the F508del mutation (AbbVie M19-530)

This study will look at the safety and effectiveness of ABBV-3067, a CFTR modulator intended to help CFTR protein function closer to normal. ABBV-3067 will be tested alone and in combination with another CFTR modulator, ABBV-2222.

 This study has two parts. In Part 1, participants will be randomly assigned to receive one of the following treatments: the study drug ABBV-3067 alone; both ABBV-3067 and ABBV-2222; or a placebo. In Part 2 of the study, some participants will receive both CFTR modulators ABBV-3067 and ABBV-2222, and some participants will receive a placebo.Researchers will test the effectiveness of ABBV-3067 alone and in combination with ABBV-2222 by measuring changes in lung function and sweat chloride. This study may require lung function tests and/or other measurements.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    Two Copies 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 have two copies of the F508del mutation. In addition, they must not have taken CFTR modulator therapies (e.g., ivacaftor, lumacaftor, tezacaftor) for at least 60 days prior to screening.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    3 months

  • Number of Study Visits:

    5

Additional Information

Study Sites

  • Closed to Enrollment

    Arkansas

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

  • Closed to Enrollment

    Florida

    Tampa General Hospital, Tampa, FL 33606

  • Closed to Enrollment

    Iowa

    University of Iowa, Iowa City, IA 52242

  • Closed to Enrollment

    Missouri

    SSM Health Saint Louis University Hospital, St. Louis, MO 63110

  • Closed to Enrollment

    South Carolina

    Medical University of South Carolina, Charleston, SC 29425

  • Closed to Enrollment

    Tennessee

    Vanderbilt University Medical Center, Nashville, TN 37232

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    Two Copies 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 have two copies of the F508del mutation. In addition, they must not have taken CFTR modulator therapies (e.g., ivacaftor, lumacaftor, tezacaftor) for at least 60 days prior to screening.

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