Lead Sponsor

EMD Serono

Collaborators

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

No

•Male or female 16 years of age or older
•Disease history of at least six months meeting at least 4 out of the 11 American College of Rheumatology (ACR) criteria for SLE
•Active SLE with at least one British Isles Lupus Assessment Group (BILAG) flare A or B at screening requiring a change in the dose of corticosteroids
•Positive antinuclear antibody (ANA) or anti-double-stranded deoxyribonucleic acid (dsDNA) at screening
•Female subjects must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks prior to Study Day 1, during the trial and 24 weeks after the last dose of study medication

•Active moderate to severe glomerulonephritis (kidney impairment) as defined in the protocol
•Active central nervous system SLE deemed to be severe/progressive and/or associated with significant cognitive impairment leading to inability to provide informed consent and/or comply with the protocol
•Previous treatment with rituximab, abatacept, or belimumab
•History of demyelinating disease such as multiple sclerosis (MS) or optic neuritis