A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus

This first-in-human, multicenter study to evaluate the administration of placebo or AMG 811 single subcutaneous and intravenous dose to subjects with SLE

Inclusion Criteria:

• Diagnosis of SLE ncluding a positive antinuclear antibodies (ANA) test at least 6 months before randomization; any concurrent SLE pharmacologic regimen (including leflunomide, methotrexate, and anti-malarials) was stable for at least 30 days before randomization; prednisone ≤ 20 mg/day (or equivalent) was permitted; 1 increase or decrease of ≤ 5mg/day prednisone equivalent was allowed within 30 days before randomization

Exclusion Criteria:

• Subjects who, in the clinical judgment of the investigator, had severe disease; subject who had at least 1 BILAG 'A' score or 2 BILAG 'B' scores in any of the organ systems at screening; signs or symptoms of a viral or bacterial infection within 30 days of study randomization, or recent history of repeated infections, evidence of liver disease; concurrent receipt of mycophenolate mofetil or azathioprine; prior administration of another biologic that primarily targets the immune system within 1 year