Systemic lupus erythematosus (SLE, lupus) is an autoimmune disorder characterized by dysregulated immune responses and subsequent production of autoantibodies. In recent years, data suggests that changes in certain kinds of immune cells, dendritic cells, affect development of lupus.
The primary objective of the study is to assess whether Orelvo, added to the standard of care treatment for patients with Lupus Nephritis, is able to reduce disease activity. The study will last for about 1 years and will involve 16 study visits. Patients who meet criteria will be assigned to one of two groups: One group will receive Orelvo 23.7mg taken twice a day by mouth, and the other will receive placebo. The study is blinded, with means neither the patient nor the study doctor will know what group subjects are in. Patients will be followed closely by the study doctors to determine their lupus activity levels over the course of 1 year.
This study will feature a one time visit, for both subjects with lupus. Blood samples, brief medical exam, medical history and skin tissue acquisition will be performed on all subjects. Qualifying subjects will be compensated for their time and effort.