Patient description: A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts.

Clinical trial eligibility criteria: eligible ages (years): 20.0-999.0,  Systemic Lupus Erythematosus Subjects who gave consent to this study participation and signed into informed consent form Subjects who are at least 20 years of age at Screening visit Have a clinical diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) classification with 4 or more of the 11 ACR present, serially or simultaneously during any interval or observation Be on either no SLE medication or a stable SLE treatment regimen of any medication (e.g., low-dose prednisone, NSAIDs; alone or in combination) for a period of at least 2 months prior to the Screening visit Males and females. A female subject is eligible to enter the study if at least one of the following conditions apply Not pregnant or nursing Of non-childbearing potential (ie, women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or Of childbearing potential (ie, women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to 1 of the following Complete abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle, from 2 weeks prior to administration of the 1st dose of investigational product until 8 weeks after the last dose of investigational product; or Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the investigational product and for 8 weeks after the last dose of investigational product  Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan),or high-dose prednisone (>60 mg/day) within 6 months prior to the Screening visit The subject has severe lupus kidney disease (defined by proteinuria > 6 g/day) within 6 months prior to the Screening visit Received IVIG or plasmapheresis within 6 months prior to Screening visit Active CNS lupus [including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), motor neuropathy, vasculitis] requiring medical intervention within 6 months prior to Screening visit The subject has hypogammaglobulinemia or IgA deficiency (IgA level < 10 mg/dL) History of renal transplant History or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk History of any other medical disease, laboratory abnormalities, or conditions which would make the subject (in the opinion of the Investigator) unsuitable for the study History of any infection requiring hospitalization or parenteral antibiotics within 4 weeks prior to Screening visit The subject has an abnormality on 12-lead ECG at screening which is clinically significant in the opinion of the investigator