NCT03451045

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 447 (actual)
• Sponsor: Corbus Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Lenabasum 20 mg	Subjects will receive lenabasum 20 mg twice daily.
DRUG	Lenabasum 5 mg	Subjects will receive lenabasum 5 mg twice daily.
OTHER	Placebo	Subjects will receive placebo twice daily.

Timeline

• Start date: 2017-12-22
• Primary completion: 2020-06-17
• Completion: 2020-06-17
• First posted: 2018-03-01
• Last updated: 2023-01-18
• Results posted: 2023-01-18

Locations

105 sites across 21 countries: United States, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study