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Anti-Inflammatory Completed with Results

Phase 2 study of LAU-7b in adults with CF (APPLAUD) (Laurent LAU-14-01)

This study looked at the safety and effectiveness of the anti-inflammatory drug LAU-7b compared with placebo control. 

Adult participants were randomly assigned to receive either a daily dose of 300 mg LAU-7b or placebo over six 21-day treatment cycles. Cycles were separated by 7 days. The study assessed the safety and tolerability of LAU-7b through physical examinations, vital signs, ECG, safety laboratory tests, and adverse events reporting. Researchers also looked at the absolute change in FEV1 at 24 weeks compared with participants’ baseline.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 100%

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

Other Primary Eligibility Criteria

Must have had history of pulmonary exacerbation, defined as at least one (1) pulmonary exacerbation in the year prior to Screening which resulted in documented IV or oral antibiotics

Study Results

  • What We Learned:

    LAU-7b treatment does not result in significantly better lung function after 24 weeks when compared with placebo. 

  • Primary Findings:

    Effectiveness:

    This study was conducted between November 2018 and March 2021 and enrolled a total of 166 participants. 

    The primary outcome was change in lung function from baseline to week 24. This study did not meet its primary efficacy outcome since both LAU-7b and placebo treated groups had a small and similar loss of lung function. 

     

    The study could not show if LAU-7b reduces pulmonary exacerbations compared with placebo because both groups had unexpectedly low rates of pulmonary exacerbations.

    Safety:

    LAU-7b was generally safe and well tolerated. More participants who receive LAU-7b discontinued the study early (28%) compared with placebo (15%). No participant discontinued due to severe adverse events related to the study drug.

  • Citation:

    J Cyst Fibros ;DOI https://doi.org/10.1016/j.jcf.2024.07.004 [Epub ahead of print]

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:

    189 days

  • Number of Study Visits:

    6

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Laurent Pharma

  • Study Drugs:

    LAU-7b

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 100%

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

Other Primary Eligibility Criteria

Must have had history of pulmonary exacerbation, defined as at least one (1) pulmonary exacerbation in the year prior to Screening which resulted in documented IV or oral antibiotics

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