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Anti-Inflammatory Completed with Results

Phase 2 study of CTX-4430 in people with CF (EMPIRE) (Celtaxsys CTX-4430)

This study evaluated the safety and effectiveness of the anti-inflammatory drug CTX-4430 (acebilustat).

 

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years to 30 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    50% or greater

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

Other Primary Eligibility Criteria

Eligible patients will have had at least 1 acute pulmonary exacerbation in the 12 months prior to screening

Study Results

  • What We Learned:

    Treatment with acebilustat, a leukotriene A4 hydrolase inhibitor, did not result in significantly better lung function or less risk of acute pulmonary exacerbation over 48 weeks compared to placebo.

  • Primary Findings:

    Effectiveness:

    This study was conducted between October 2015 and May 2018. The study enrolled a total of 199 patients across the three cohorts: 50mg CTX-4430, 100gm CTX-4430, or placebo.

     

    The primary outcome was change in ppFEV1 from baseline to 48 weeks. This study did not meet the primary efficacy outcome as there was no significant difference between the three groups.

     

    The number of pulmonary exacerbations were measured through 48 weeks and compared between treatment groups, along with several other outcomes of interest. No significant difference in the rate of exacerbations was found between the groups or when combining the CTX-4430 groups and comparing with the placebo group. There was a trend toward fewer exacerbations in people with ppFEV1 >75 who received CTX-4430.

    Safety:

    The number of all adverse events and serious adverse events did not significantly differ between the three groups.

  • Citation:

    J Cyst Fibros 2021;DOI 10.1016/j.jcf.2021.08.007(20):1026-1034

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:

    1 years

  • Number of Study Visits:

    15

Additional Information

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years to 30 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    50% or greater

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

Other Primary Eligibility Criteria

Eligible patients will have had at least 1 acute pulmonary exacerbation in the 12 months prior to screening

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