Lenabasum in Cystic Fibrosis

Details

Therapeutic category
Anti-Inflammatory
Trial status
Closed to recruitment - in follow up Participating Centres
Phase
Phase II

Full title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

This study is designed to evaluate the effectiveness and safety of lenabasum (JBT-101) in people with CF who have had pulmonary exacerbations. Lenabasum (JBT-101) is an oral medication that is aimed at reducing inflammation. It is thought to help the body increase production of anti-inflammatory molecules while reducing production of molecules that increase inflammation. Reduction of inflammation helps prevent permanent tissue damage in the lungs that happens when CF patients have pulmonary exacerbations. For study participants this study includes 6 months of study treatment with a 1 month follow up period. Study participants may remain on their current CF treatments
Trial Reference Number
106210
Trial type
Medication
Intervention
Lenabasum (anti-inflammatory)
Recruitment target
415
Last edited date
03/09/2019
CF sponsor
Corbus Pharmaceuticals Inc.
CF sponsor type
Commercial

Who can take part?

Top inclusion criteria
  • 12 Years and older
  • Over 40 kg
  • Able to perform pulmonary function tests
Top exclusion criteria
  • Severe or unstable CF at screening or visit one
  • Actively listed on an organ transplant list or have had an organ transplant other than corneal transplant

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