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Restore CFTR Function Closed to Enrollment

Phase 3 study of VX-659 triple combination drug in people with CF ages 12 years and older who have two copies of the F508del mutation (VX17-659-103)

This randomized, placebo-controlled study is taking place at multiple care centers across the U.S. It will look at the effectiveness and safety of the drug VX-659 in combination with ivacaftor and tezacaftor. It is for people with CF ages 12 and older who have two copies of the F508del CFTR mutation.

 This study is controlled, meaning that some participants will receive the triple combination of VX-659 with ivacaftor and tezacaftor, and others will receive placebo with ivacaftor and tezacaftor. Researchers will test the effectiveness of VX-659 with ivacaftor and tezacaftor by measuring lung function. They will also assess safety by tracking adverse events.This study is for people who have two copies of the F508del CFTR mutation. This study may require lung function tests, sweat tests, blood draws, and/or other measurements.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    12 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 be homozygous for F508del.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    10 weeks

  • Number of Study Visits:

    7

Additional Information

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    12 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 be homozygous for F508del.

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