Phase 3 DETERMINE Study in Dermatomyositis
Double-blind, randomized, placebo-controlled, efficacy and safety study
Primary Endpoint: American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) 2016 Total Improvement Score (TIS) in Adult Dermatomyositis & Polymyositis
Secondary Endpoints: Change in CDASI activity score
Key study inclusion criteria:*
- Diagnosis of dermatomyositis with active skin, muscle, or other organ involvement
- 18 years of age or older at the time Informed Consent is signed
- On stable doses of DM medications, including immunosuppressives
*There are additional criteria you must meet to be able to participate in this study.
Results from previous studies:
- The investigational drug lenabasum successfully achieved the primary objective of a Phase 2 study in 22 adults by demonstrating that lenabasum had a mean improvement (reduction) in the primary efficacy outcome, the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) activity score was 9.3 points for lenabasum treatment at the end of the study versus a reduction of 3.7 points for placebo treatment (p = 0.04) in patients with skin-predominant dermatomyositis. The most common adverse events were dizziness (45.5% vs 18.2% of lenabasum and placebo subjects) and dry mouth (36.4% vs 9.1% of lenabasum and placebo subjects). To learn more about the study, click here.
- Corbus received approval for an open-label extension (OLE) to its single center, double-blind, randomized, placebo-controlled Phase 2 clinical study of lenabasum for dermatomyositis from the U.S. Food and Drug Administration (FDA) in November 2016 to collect long term safety and efficacy data on lenabasum. In October 2018, Corbus reported that lenabasum demonstrated continued improvement in subjects with DM. The CDASI activity score improved from study start by a mean of -15.4 points at 6 months to -17.6 points at 12 months. Lenabasum-related AEs occurring in more than 1 subject during chronic dosing was fatigue (n = 2, 10%). To learn more about the study, click:
Medical professionals may email us at DMphysicians@corbuspharma.com for more information about study participation.
Patients, caregivers or patient advocates looking for additional information may email us at DMpatients@corbuspharma.com.
For any other inquiries, please see our Contact Us page.