A Phase 2B Open-Label, Single-Arm, Repeat-Dose Study to Evaluate the Reliability of an Autoinjector

Exclusion Criteria

• •Have previously participated in a study of SC belimumab.
• •Have received a live vaccine within 30 days of Day 0 or anticipate receipt of a live vaccine during the study or within 120 days after the last injection of study drug.
• •Have received a non-biologic investigational agent within 60 days of Day 0.
• •Have severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), cerebritis or CNS vasculitis requiring therapeutic intervention within 60 days of Day 0.
• •Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.
• •Have a planned surgical procedure
• •History of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, that, in the opinion of the investigator, makes the subject unsuitable for the study.
• •Have required management of acute or chronic infections, as follows: Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria); Hospitalization for treatment of infection within 60 days of Day 0; Use of parenteral (IV or intramascular \[IM\]) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of Day 0.
• •History of or a positive test for human immuno virus (HIV) at Screening.
• •A positive Hepatitis B surface antigen or Hepatitis B core antibody, or positive Hepatitis C antibody result within 3 months of Screening or positive at Screening.
• •Have an Immunoglobulin A (IgA) deficiency (IgA level \<10 milligrams/deciliter).
• •Have a Grade 3 or greater laboratory abnormality based on the Adverse Event Severity Grading except for the following that are allowed: Stable Grade 3 prothrombin time (PT) secondary to warfarin treatment; Stable Grade 3 partial thromboplastin time (PTT) due to lupus anticoagulant and not related to liver disease or anti-coagulant therapy; Stable Grade 3/4 proteinuria (\<=6 grams/24 hour equivalent by spot urine protein to creatinine ratio allowed); Stable Grade 3 hypoalbuminemia due to lupus nephritis, and not related to liver disease or malnutrition; Stable Grade 3 gamma glutamyl transferase (GGT) elevation due to lupus hepatitis, and not related to alcoholic liver disease, uncontrolled diabetes, or viral hepatitis. If present, any abnormalities in the ALT and/or aspartate aminotransferase (AST) must be\<= Grade 2; Stable Grade 3 neutropenia or stable Grade 3 white blood cell count. Note: All Grade 3 or greater laboratory abnormalities will be flagged in the laboratory report. Therefore the above exceptions will be determined by the Investigator and Medical Monitor.
• •Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies
• •Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months, or who in the investigator's opinion, pose a significant suicide risk
• •Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Day 0
• •Are unable to administer study agent by SC injection.
• •In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a patient diary.