A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations.
A patient may be eligible for Part B of the study if he or she:
· Is between 18 and 75 years of age
· Has active CLE that has been histological confirmed (in the past or at screening)
· Has CLASI-A ≥8 at screening and randomization
· Has subacute CLE with a CLASI-A erythema score of ≥2 and/or chronic CLE, including DLE, with at least 1 active DLE lesion with a minimum CLASI-A erythema score ≥ and in addition, CLASI-D scarring score ≥1
· Has active CLE despite use of topical corticosteroid and/or antimalarial for at least 12 weeks prior to screening
· Does not have active lupus nephritis or moderate-to-severe or chronic kidney disease
· Is not taking a dose of prednisone (or its equivalent) >15 mg/day if he or she is receiving systemic corticosteroids or is taking any dose of prednisone (or its equivalent) and has been on a stable dose for ≥4 weeks prior to randomization