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, Europe, and Australia. 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 Type: Interventional  (Clinical Trial)
Estimated Enrollment: 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, double-blind, randomized, placebo-controlled, parallel group study.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Actual Study Start Date: December 22, 2017
Estimated Primary Completion Date: September 2019
Estimated Study Completion Date: November 2019

Arms:
- Experimental: Lenabasum 20 mg BID
- Experimental: Lenabasum 5 mg BID
- Placebo Comparator: Placebo BID