Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis

Phase 3 Completed 176 enrolled Corbus Pharmaceuticals Inc.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2018-12-17
Primary completion: 2021-03-31
Completion: 2021-10-05

Outcome

Missed primary endpoint

release “The primary endpoint in the D ETER M INE Phase 3 study of lenabasum in dermatomyositis was not met” corbuspharma.com ↗

Publications

Kodali N, Diaz D, Dhiman R, Vazquez T, Feng R, Patel J, Dan J, Sprow G, Kleitsch J, Sharma M, Bashir M, Werth VP. Diverse Lenabasum pathway activation in dermatomyositis patients' blood. Sci Rep. 2025 May 18;15(1):17232. doi: 10.1038/s41598-025-92001-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenabasum	Small molecule	5 mg	Oral
Subject	Lenabasum	Small molecule	20 mg	Oral