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Clinical trials identifierNCT02465450
Study codesJBT101-CF-001
Study titleA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis
Drug (brand name)JBT-101 (Anabasum; an anti-inflammatory drug)
Drug administrationCapsule
Eligible CF patientsAdults with CF
Controlled study?Yes, placebo controlled
Randomised study?Yes
Blinded study?Yes (double blinded. Neither the participant, nor the medical staff knows which group the participant is in)
Extension study?No
Study timeframeThe study was conducted between September 2015 and December 2016

Study:This Phase 2 study was conducted in 27 sites across 7 countries. 
Aim:The aim was to determine the safety, tolerability, pharmacokinetics, and efficacy of JBT 101 in adults with CF. 
Participants:85 adults with CF were enrolled and randomized to receive JBT 101 or placebo for 84 days. There were 9 participants from 3 ECFS-CTN sites in Germany, Italy and the UK (Frankfurt, Milan, Belfast)
Treatment:In Weeks 1-4, participants received placebo or JBT 101 1 mg or 5 mg once daily.
In Weeks 5-12, participants received JBT 101 20 mg once or twice daily, or placebo.
Safety:    The primary outcome was safety, measured by the number of adverse events.
There were 6 serious adverse events in participants taking JBT-101 and 6 in participants taking placebo. None of the serious adverse events were judged to be linked with JBT-101. Overall, 54-68% of participants taking JBT-101 had adverse events versus 43-58% in participants taking placebo. Most adverse events involved the respiratory system.
Efficacy:Participants taking JBT-101 had fewer acute pulmonary exacerbations. This reduction was best with the highest dose of JBT-101 (75% reduction with JBT-101 20 mg twice daily)
Data source:This preliminary summary of data provided here is from a press release from the manufacturer:
and from and from a conference abstract