Today, Corbus Pharmaceuticals announced the start of DETERMINE, a Phase 3 trial designed to evaluate the efficacy and safety of lenabasum for the treatment of adults with dermatomyositis.
Some important highlights of this study are below:
- DETERMINE is a double-blind, placebo-controlled 1-year study designed to test the efficacy and safety of lenabasum in approximately 150 adults with dermatomyositis (DM).
- Primary efficacy outcome: Total Improvement Score (TIS) at Week 52 (American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) 2016 Total Improvement Score (TIS) in Adult Dermatomyositis & Polymyositis)
- Secondary efficacy outcome: Change from Baseline in the Cutaneous Dermatomyositis Activity and Severity index (“CDASI”) activity score at Week 52
- If the efficacy data from DETERMINE are positive and the safety profile continues to be favorable, Corbus intends to approach regulatory authorities about a registration package for lenabasum for treatment of DM.
If you are an adult with dermatomyositis and are interested in participating in the study, visit https://www.corbuspharma.com/clinical-trials/phase-3-study-in-dermatomyositis.Tags: clinical trials dermatomyositis