Study Results

• What We Learned:

  JBT-101 was overall safe and well-tolerated. No benefit over placebo was observed in the number of pulmonary exacerbations or on pulmonary function.

• Primary Findings:

  Effectiveness:

  JBT-101 was overall safe and well-tolerated. The rate of pulmonary exacerbations was similar across all three groups. Median times to first new pulmonary exacerbation were 165 days (20 mg JBT-101), 148 days (5 mg JBT-101) and 143 days (placebo). The study did not show significant changes to participants’ baseline FEV1 in any of the 3 groups.

   

  Safety:

  This study was conducted between May 2018 and July 2020.

  This study enrolled 447 participants of whom 387 completed the treatment period. Serious adverse events occurred at a similar rate in treatment groups (30% for 20mg and 28% for 5mg) compared with placebo (29%). Participants discontinued the study for various reasons. The discontinuation rate among participants receiving the study drug was not higher than in the placebo group (15% of participants receiving 20mg, 7% of participants receiving 5mg, and 15% of participants receiving placebo). 

   

  Results have not been peer-reviewed and come from https://clinicaltrials.gov/study/NCT03451045 

• Citation:

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