An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)

A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus

This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus erythematosus (SLE).

Inclusion Criteria:

• Diagnosis of SLE
• Disease duration longer or equal to 6 months
• Stable, mild to moderate active SLE
• Receiving stable maintenance therapy

Exclusion Criteria:

• Significant lupus nephritis
• Active central nervous system (CNS) disease
• Significant arterial or venous thrombosis (blood clots) within 12 months prior to dosing
• Active vasculitis requiring treatment
• Body weight over 120 kg
• History of cancer
• Infections
• viral: HIV, hepatitis B or C, Epstein-Barr virus (EBV), cytomegalovirus (CMV), varicella zoster virus (VZV), or herpes simplex virus (HSV-1 or HSV-2)
• tuberculosis (TB)
• Severe systemic microbial infections within the past 12 months prior to dosing
• Immunosuppressive and immune modulating therapy