A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.

A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)

The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.

Inclusion Criteria:

• Patients must have previously met ≥4 of the 11 revised ACR criteria
• Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute in the past or at screening
• Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥6

Exclusion Criteria:

• Have received prednisone >20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1)

• Have received the following medications within 28 days before Visit 2 (Day 1):

  • Systemic cyclophosphamide at any dose
  • Cyclosporine at any dose
  • Tacrolimus at any dose
  • Thalidomide at any dose
  • Mycophenolate mofetil >2 g/day
  • Methotrexate >15 mg/week
  • Azathioprine >2 mg/kg/day

• Women who have a positive pregnancy test (serum hCG) at Visit 1