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Anti-Inflammatory Completed with Results
Phase 2 study of JBT-101 in people with CF (Corbus JBT101-CF-001)
This study evaluated the safety and effectiveness of the anti-inflammatory drug JBT-101 (lenabasum), as well as how the body processes the drug, in adults with CF.
In Part A of study, participants were randomized to receive lenabasum (1mg or 5mg) or placebo once daily for 4 weeks (Weeks 1-4). In Part B, participants were randomized to receive lenabasum (20mg once daily or 20mg twice daily) or placebo twice daily for 8 weeks (Weeks 5-12).
Eligibility
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Age:
18 Years to 65 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
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What We Learned:
This study found that lenabasum was generally well-tolerated. No deaths or serious or severe adverse events (AE) were considered related to lenabasum. Most AEs were mild or moderate. Three lenabasum and one placebo participant discontinued the study for a treatment related AE. There was no significant change in lung function (ppFEV1) in the combined lenabasum group compared to the placebo group at the end of Part A (Weeks 1–4) or Part B (Weeks 5–12). Significant reductions in the inflammatory biomarkers IL-8 and immunoglobulin G levels occurred with lenabasum (20mg twice daily) when compared with placebo (p < 0.05) from baseline to Week 12.
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Primary Findings:
Effectiveness:
Safety:
This study was conducted between September 29th, 2015 and December 28th, 2016. In Part A of the study, 50 participants were randomized to lenabasum (1mg n=26; 5mg n=24) and 35 participants to placebo. In Part B, 61 participants were randomized to lenabasum (20mg once daily n=31; 20 mg twice daily n=30) and 24 participants to placebo twice daily.
The primary outcome of the study was safety and tolerability of lenabasum. No deaths or serious or severe adverse events (AE) were considered related to lenabasum. Most AEs were mild or moderate, and the most common were pulmonary exacerbation, coughing up blood, dry mouth, and upper respiratory infection. Three lenabasum and one placebo participant discontinued the study for a treatment related AE.
There was no significant change in lung function (ppFEV1) in the combined lenabasum group compared to the placebo group at the end of Part A or Part B.
Significant reductions in the inflammatory biomarkers IL-8 and immunoglobulin G levels occurred with lenabasum (20mg twice daily) when compared with placebo (p < 0.05) from the beginning of the study to Week 12.
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Citation:
J Cyst Fibros 2020;DOI 10.1016/j.jcf.2020.09.008
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
127 days -
Number of Study Visits:
8
Additional Information
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Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Corbus -
Study Drugs:
Eligibility
-
Age:
18 Years to 65 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
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