A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, and Europe. The planned duration of treatment with study drug is 28 weeks.
Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.
Inclusion Criteria:
Exclusion Criteria:
Severe or unstable CF at screening or Visit 1.
Any of the following values for laboratory tests at screening:
Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.
Cleveland, Ohio 44106, United States
Hershey, Pennsylvania 17033, United States
Innsbruck, Austria
Mosdós, Hungary
Dziekanów Leśny, 05-092, Poland
Rabka-Zdrój, 34-700, Poland
Mytishchi, Russia