| Clinical trials identifier | NCT02465450 |
|---|---|
| Study codes | JBT101-CF-001 |
| Study title | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis |
| Sponsor | Corbus |
| Drug (brand name) | JBT-101 (Anabasum; an anti-inflammatory drug) |
| Drug administration | Capsule |
| Eligible CF patients | Adults 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 timeframe | The 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: https://ir.corbuspharma.com/press-releases/detail/233/corbus-pharmaceuticals-reports-positive-topline-data and from https://clinicaltrials.gov/ct2/show/study/NCT02465450?show_locs=Y and from a conference abstract http://www.cysticfibrosisjournal.com/article/S1569-1993(17)30160-1/abstract |