PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

Exclusion Criteria

• •Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
• •Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
• •Liver disease.
• •Anemia, neutropenia, or thrombocytopenia.
• •Malignancy within past 5 years
• •Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
• •History of active tuberculosis or a history of tuberculosis infection.
• •Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
• •Prior administration of any B cell depleting therapy in the past 18 months.
• •Pregnant or nursing
• •History of congenital immunodeficiency