DETERMINE, a Phase 3 trial designed to evaluate the efficacy and safety of lenabasum for the treatment of adults with dermatomyositis (DM), is now recruiting at many international locations.
Update 8/5/2020: Corbus Pharmaceuticals announced they have completed enrollment in the DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis, enrolling 176 participants. This is the largest, randomized, double-blind, placebo-controlled DM study to date. Topline results expected in the fourth quarter of 2021.
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of treatment with this study drug is 52 weeks.
In December 2018, 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:
- DETERMINEis 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 the 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.
Check out the full study details and locations recruiting on the clinical trial page at https://clinicaltrials.gov/ct2/show/NCT03813160Tags: clinical trials dermatomyositis myositis research