drugset / Trial / NCT03451045

Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

NCT03451045 ↗

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2017-12-22
Primary completion
2020-06-17
Completion
2020-06-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenabasum Small molecule 5 mg —
Subject Lenabasum Small molecule 20 mg —

Indications