Safety study of AMG 811 in subjects with Discoid Lupus Erythematosus

─ Men and women, between the ages of 18 and 70 years of age, inclusive, at the time of randomization; ─ Diagnosis of discoid lupus erythematosus (DLE) with or without SLE; ─ Intolerance of anti-malarial therapy or ≥ 3 months of anti-malarial therapy with residual disease activity. The total CLASI activity must be ≥ 10; ─ Stable dose of topical steroids no stronger than medium-potency (Class III or less) for ≥ 2 weeks and/or systemic immunosuppressive therapy at stable dose for ≥ 8 weeks prior to randomization (except for leflunomide which requires ≥ 12 weeks) are permitted; ─ Oral prednisone ≤ 20 mg/day (or equivalent) is permitted; one increase or one decrease of ≤ 5 mg/day prednisone equivalent (not to exceed 20 mg/day) will be allowed within 30 days before randomization;

─ Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of DLE or SLE) that would, by its progressive nature and/or severity, interfere with the study evaluation, completion and/or procedures per the investigator’s discretion; ─ History of malignancy; ─ 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 ─ Positive serology for HIV antibodies, hepatitis B surface antigen or hepatitis C antibodies (confirmed by PCR or RIBA) during the screening period; ─ Receipt of a live vaccine within 3 months of study randomization and during the study; ─ Prior use of the following agents: ─ Administration of an investigational biologic agent that primarily targets the immune system – ─ Rituximab, Lymphostat-B, or TACl-Ig within 9 months prior to randomization (or comparable B cell depleting or B cell inhibiting biologics); Rituximab (or other depleting CD20 targeted agents) treated patients must demonstrate a return of CD19+ B cells to > 5/μL; ─ CTLA4-Ig within 3 months prior to randomization; ─ Other agents within 5 half-lives prior to randomization; ─ Administration of cyclosporine, tacrolimus, sirolimus, IV immunoglobulin, and/or plasmapheresis within 3 months of randomization; ─ Administration of thalidomide or lenalidomide within 3 months of randomization; ─ Administration of oral or IV cyclophosphamide (or any other alkylating agent) within 9 months of randomization;