- Male and/or female subjects between the ages of 21 to 70 who have a clinical
diagnosis of either discoid cutaneous lupus erythematosus or subacute cutaneous lupus
erythematosus with or without systemic lupus erythematosus prior to screening that
has been confirmed by evaluation of skin biopsy sample.
- Active disease at both screening and baseline (Day 1) defined by a CLASI score of
greater than or equal to 10.
- Intolerance to antimalarial therapy or more than 3 months of antimalarial therapy
with disease activity.
- Use of greater than or equal to 20 mg or prednisone (or equivalent) within 3 months
of Day 1.
- Signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic
infection, or recent history of repeated infections
- Subjects with evidence of past or active tuberculosis
- Pregnant, planning to get pregnant, and/or lactating females or males planning to
father a child within time period of the study or subsequent exclusionary period.