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Anti-Inflammatory Completed with Results

KB001-A in people with CF and Pseudomonas aeruginosa (KaloBios KB001-05)

This study evaluated the safety and effectiveness of the drug KB001-A compared with placebo. This study was for people who have chronic Pseudomonas aeruginosa (Pa) airway infection.

Participants were randomized to receive up to five intravenous (IV) infusions of 10 mg/kg (receiving a maximum dose of 800mg) or placebo IV infusions for a 16-week treatment period. For the first 4 weeks of the treatment period, all participants continued their regularly scheduled inhaled antibiotic regimen, after which participants discontinued their inhaled antibiotic treatment for the remaining 12 weeks. This trial included a sub-study where respiratory symptoms and sputum inflammation proteins were evaluated in a small number of participants (N=16 for KB001-A and N=13 for placebo).

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    12 Years to 50 Years

  • 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

Received anti-pseudomonal inhaled antibiotics for the equivalent of 8 weeks or greater in the 26 weeks before the Day 0 Visit. Note: Chronic daily anti-pseudomonal inhaled antibiotic regimens are allowed. Individuals with CF who are older than 50 years may participate if they have been treated with 2 or more courses of antibiotics (IV and/or oral) for respiratory signs and symptoms (CF exacerbation) in the 12 months before the Screening Visit.

Study Results

  • What We Learned:

    This study found that participants receiving KB001-A did not have a significant impact on increasing the length of time before needing antibiotics due to worsening respiratory signs and symptoms when compared with placebo.  Overall, the drug KB001-A was generally well-tolerated. 

  • Primary Findings:

    Effectiveness:

    This study was conducted between December 2012 and December 2014. In the primary study, 169 participants were randomized to receive either KB001-A (N=83) or placebo (N=86). 

     

    The primary objective of this study was to evaluate the effectiveness of KB001-A on increasing the length of time before needing antibiotics due to worsening respiratory signs and symptoms. This study did not meet the primary objective as there was no statistical difference observed in the time-to-need for antibiotics in the KB001-A group when compared with placebo over the 16-week study period.  

     

    A small increase in lung function for participants receiving KB001-A vs. placebo was observed by week 16 (3.2% ppFEV1 increase vs. placebo, p=0.003). In the sub-study of relatively few patients, protein concentrations of IL-8 (a protein that measures inflammation) were found to have decreased in participants receiving KB001-A vs. placebo (-0.27 log10pg/mL, p=0.048). Several other measures of inflammation in the sputum were lower in participants receiving KB001-A vs. placebo but the differences were not statistically significant.

    Safety:

    In general, KB001-A was well tolerated when compared to placebo. The number of hospitalizations was higher in the KB001-A group than placebo (28.9% vs. 16.3%) but the difference was not significant. There was one incidence of a serious adverse event of elevated liver enzymes but it was unclear if this was caused by KB001-A. 

  • Citation:

    J Cyst Fibros 2017;DOI 10.1016/j.jcf.2017.12.006 [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:

    20 weeks

  • Number of Study Visits:

    10

Additional Information

  • Phase: ?more info

    Phase Two

  • Study Sponsor: ?more info

    Kalobios

  • Study Drugs:

    KB001-A

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    12 Years to 50 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40 to 100%

  • Pseudomonas Status:

    Positive Respiratory Cultures Required

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

Other Primary Eligibility Criteria

Received anti-pseudomonal inhaled antibiotics for the equivalent of 8 weeks or greater in the 26 weeks before the Day 0 Visit. Note: Chronic daily anti-pseudomonal inhaled antibiotic regimens are allowed. Individuals with CF who are older than 50 years may participate if they have been treated with 2 or more courses of antibiotics (IV and/or oral) for respiratory signs and symptoms (CF exacerbation) in the 12 months before the Screening Visit.

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