
Click image to enlargeThe primary objective of this study is to demonstrate efficacy of BIIB059 compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity. Phase 3
Criteria:--Must be diagnosed with SLE at least 24 weeks prior to screening
-- Must not have a history of or positive test result for human immunodeficiency virus (HIV)
-- Must not have current Hepatitis B or C infection
-- Must not have a history of severe herpes infection
-- Must not have a presence of uncontrolled or class III or IV congestive heart failure.
--Must not have active severe Lupus Nephritis
-- Must not have any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE skin lupus manifestation or drug-induced lupus.
-- Must not have a history or current diagnosis of a clinically significant non-SLE-related vasculitis syndrome
-- Must not have active neuropsychiatric SLE
--Must not use oral prednisone (or equivalent) above 20 mg/day.