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 clinicaltrials.gov: ClinicalTrials.gov 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.
Medical professionals may email us at CFphysicians@corbuspharma.com for more information about study participation.
Patients, caregivers or patient advocate looking for additional information may email us at: CFpatients@corbuspharma.com.
For any other inquiries, please see our Contact Us page.