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Phase 3 Study in Dermatomyositis

In December of 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:

  • 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.

Find Available Locations

Check out the currently available locations, updated Friday, September 13, 2019 on the  ClinicalTrials.gov website.

View recruiting locations
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Myositis Support and Understanding Association (MSU) is a patient-centered, all-volunteer 501(c)(3) nonprofit organization Empowering the Myositis Community. Founded by Myositis patients, for Myositis patients, MSU provides education, support, advocacy, access to research and clinical trial matching, and need-based financial assistance.

View more information: Myositis Support

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