At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 85 enrolled
Drug / intervention
JBT-101 (lenabasum) +1 moredrug
Likely dose
JBT-101 (lenabasum) 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis
In Brief
A Phase 2 clinical trial evaluating JBT-101 (lenabasum) and Placebo for Cystic Fibrosis. Completed, enrolled 85 participants across 27 sites in 7 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesBelgium, France, Germany, Italy, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartSep 2015
Primary CompletionDec 2016
TodayJul 2026
First PostedJun 8, 2015
Enrollment StartSep 29, 2015
Primary CompletionDec 28, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.1 years ago
Interventions
JBT-101 (lenabasum)drug
Subjects will receive JBT-101 1 mg qd or JBT-101 5 mg qd on Days 1-28. Subjects will receive either JBT-101 20 mg q am (with placebo q pm) or JBT-101 20 mg twice a day on Days 29-84.
Placeboother
Subjects will receive placebo once a day on Days 1-28, placebo q pm on Days 29-84 (with JBT-101 20 mg q am), or placebo bid on Days 29-84.