NCT03398837

Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Corbus Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.

Conditions

• Diffuse Cutaneous Systemic Sclerosis

Interventions

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

Timeline

• Start date: 2017-12-18
• Primary completion: 2020-05-27
• Completion: 2020-12-21
• First posted: 2018-01-16
• Last updated: 2021-03-29

Locations

74 sites across 12 countries: United States, Australia, Canada, Germany, Israel, Japan, Netherlands, Poland, South Korea, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study