NCT03813160

Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (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 dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.

Detailed description

Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 28 will compare lenabasum 20 mg BID to placebo the Total Improvement Score (TIS), which is a weighted composite measure of improvement from baseline in six endpoints: Physician Global Assessment of Disease Activity, Physician Assessment of Extramuscular Disease Activity, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire (patient-reported disability), Manual Muscle Testing (MMT), and muscle enzymes.

Conditions

• Dermatomyositis

Interventions

Type	Name	Description
DRUG	Lenabasum 20 mg	oral capsule
DRUG	Lenabasum 5 mg	oral capsule
DRUG	Placebo	oral capsule

Timeline

• Start date: 2018-12-17
• Primary completion: 2021-03-31
• Completion: 2021-10-05
• First posted: 2019-01-23
• Last updated: 2022-08-16

Locations

54 sites across 13 countries: United States, Bulgaria, Canada, Czechia, Germany, Hungary, Italy, Japan, Poland, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study