Systemic Lupus Erythematosus
This Phase 2 SLE clinical trial is being conducted by the Autoimmunity Centers of Excellence (ACE) program, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Cynthia Aranow, M.D., of the Feinstein Institute for Medical Research (FIMR), Manhasset, NY, is Principal Investigator for ACE, and Meggan Mackay, M.D., M.S., is Principal Investigator for the clinical trial of lenabasum in SLE. Drs. Aranow and Mackay are Investigators at the Center for Autoimmunity & Musculoskeletal Disease at FIMR and Associate Professors of Molecular Medicine at Hofstra Northwell School of Medicine.
The randomized, double-blind, placebo-controlled, Phase 2 trial will be conducted at 15 sites in the United States and will enroll 100 adult SLE patients with active musculoskeletal disease, which is the most common disease manifestation of SLE. Subjects will be randomized in a 1:1:1:1 ratio to one of four cohorts to receive placebo or three different doses of lenabasum for 3 months, with 1-month follow-up. The primary efficacy outcome assesses pain from active musculoskeletal disease, and secondary efficacy outcomes include other assessments of active musculoskeletal disease, overall disease activity using SLE Responder Index, SLE Disease Activity Index ("SLEDAI") and British Isles Lupus Activity Group ("BILAG") scoring systems, and patient-reported outcomes.
For more information on this study, please visit ClinicalTrials.gov and reference Identifier NCT03093402.