Phase 2b Study in Cystic Fibrosis (CF)

Double-blind, randomized, placebo-controlled, efficacy and safety study

Open to people with CF 12 years and older, regardless of mutation or current background medications, including approved CFTR modulators (e.g. Orkambi®, Kalydeco® or Symdeko®)

Primary Endpoint: Event rate of pulmonary exacerbations (PEx)

Secondary Endpoints: Other measures of PEx; CFQ-R Respiratory Domain Score; FEV1 % predicted

Key study inclusion criteria:*

  • Have a diagnosis of cystic fibrosis
  • At least 12 years of age
  • Had at least 2 pulmonary exacerbations in the last year (at least 1 of them requiring treatment with IV antibiotics)

*There are additional criteria you must meet to be able to participate in this study.

For Complete Study Details, Please View the Study Listing on Identifier: NCT03451045

Results from previous studies:

  • The investigational drug lenabasum successfully achieved the primary objective of a Phase 2 study in 85 adults by demonstrating an acceptable safety and tolerability profile at all doses with no serious or severe adverse events related to the study drug. Data also showed a reduction in acute PEx and multiple inflammatory biomarkers in patients with cystic fibrosis. The most common adverse event was mild dry mouth, observed in 8 (13%) of lenabasum patients and no placebo patients. To learn more about the study, click here.

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