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Restore CFTR Protein Completed with Results

Phase 2 study of CTP-656 in adults with CF who are currently taking ivacaftor (Kalydeco®) (Concert CTP-656)

This study evaluated the safety and effectiveness of the drug CTP-656 in adults with CF who have a gating mutation and are currently taking ivacaftor (Kalydeco®).

 Participants were randomly assigned to receive one of three doses of CTP-656 (20mg, 100mg, or 150mg daily), placebo or to keep taking their ivacaftor (150mg twice daily) for 28 days.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    One Copy F508del or No Copies F508del

  • FEV1% Predicted:

    60% or greater

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

Other Primary Eligibility Criteria

This study is for people who are already taking ivacaftor (Kalydeco®), and who have at least one copy of one of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R.

Study Results

  • What We Learned:

    The Concert Pharmaceuticals compound, CTP-656 (deuterated ivacaftor), was purchased by Vertex Pharmaceuticals in July 2017. Drug development of CTP-656 has continued with Vertex under the new compound name, VX-561. There is an ongoing Vertex trial evaluating VX-561, the VX-561-101 trial.

  • Primary Findings:

    Effectiveness:

    Safety:

  • Citation:

For current information about the overall development status of this drug, please check the Drug Development Pipeline.

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    7 weeks

  • Number of Study Visits:

    6

Additional Information

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    One Copy F508del or No Copies F508del

  • FEV1% Predicted:

    60% or greater

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

Other Primary Eligibility Criteria

This study is for people who are already taking ivacaftor (Kalydeco®), and who have at least one copy of one of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R.

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