Corbus Pharma (CRBP) Reports Complete Enrollment in NIH-Sponsored Phase 2 Study of Lenabasum for Treatment of Systemic Lupus Erythematosus
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Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) today announced that the last participant was enrolled in a Phase 2 study of lenabasum for the treatment of systemic lupus erythematosus (SLE).
The 16-week, U.S., multi-center, first-in-patient, exploratory clinical trial enrolled 101 participants to evaluate the safety, efficacy, and tolerability of lenabasum in adults with SLE who are receiving standard treatments, including background immunosuppressive therapies. This study is the first randomized, double-blind, placebo-controlled study targeting the potential role of the cannabinoid receptor type 2 in SLE. Patients in the study are randomized 1:1:1:1 to either receive lenabasum 20 mg twice daily, lenabasum 20 mg once daily, lenabasum 5 mg twice daily, or placebo.
The primary efficacy endpoint is change from baseline in the 7-day average of the maximum daily Numerical Rating Scale-Pain score at Week 12. Secondary efficacy assessments include other evaluations of musculoskeletal pain and disease activity, SLE Responder Index, SELENA-SLEDAI score, BILAG-2004 score, Physician Global Assessment, Lupus Activity Patient Global Assessment, and PROMISE-29 scores. Various biomarkers will also be measured.
The clinical trial (ClinicalTrials.gov identifier: NCT03093402) is led by principal investigator, Meggan Mackay, M.D., professor at the Feinstein Institutes for Medical Research, and is sponsored and funded (UM1AI110494) by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH). Topline results from the study are expected in the second half of 2021.
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