At a glance
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
In Brief
A Phase 2 clinical trial evaluating Lenabasum 20 mg, Lenabasum 5 mg, and 1 other intervention for Cystic Fibrosis. Completed, enrolled 447 participants across 105 sites in 21 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Subjects will receive lenabasum 20 mg twice daily.
Subjects will receive lenabasum 5 mg twice daily.
Subjects will receive placebo twice daily.