Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.

A Phase 2, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Intravenous Dose of MEDI-546, a Human Monoclonal Antibody Directed Against Type I Interferon Receptor (IFNAR), in Japanese Subjects With Active Systemic Lupus Erythematosus (SLE).

The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEDI-546 in Japanese SLE patients.

A phase 2, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of intravenous dose of MEDI-546, a human monoclonal antibody directed against type I interferon receptor (IFNAR), in Japanese subjects with active systemic lupus erythematosus (SLE)

Inclusion Criteria:

• Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE.
• Weight greater than or equal to 40.0 kg.
• Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for ≥ 24 weeks prior to screening.
• Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives.
• Active moderate to severe SLE disease based on SLE disease activity score.

Exclusion Criteria:

• Active severe or unstable neuropsychiatric SLE.
• Active severe SLE-driven renal disease or unstable renal disease.
• Clinically significant active infection including ongoing and chronic infections.
• Known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus infection or splenectomy that predisposes the subject to infection.
• Confirmed positive tests for hepatitis B or positive test for hepatitis C.