Systemic Lupus Erythematosus
Corbus has amended the protocol to one of its existing Investigational New Drug (IND) applications with the U.S. Food and Drug Administration to initiate a Phase 2 clinical study of anabasum for the treatment of systemic lupus erythematosus. The Phase 2 study will be funded by a grant from the National Institutes of Health (NIH) to the Feinstein Institute for Medical Research and is expected to commence in the third quarter of 2017.
- Primary Endpoints: Efficacy in inflammatory pain in subjects with active musculoskeletal disease
- Secondary Endpoints: Efficacy in overall disease activity, musculoskeletal disease, and quality of life, safety and tolerability, biomarkers of inflammation, metabolipidomic profile, and pharmacokinetics
- Patient Number: 100 adults with SLE at 10 U.S. sites
- Treatment Duration: 84 days treatment with 28 days follow-up