Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus

Inclusion Criteria:

- 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;

Exclusion Criteria:

- 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;