A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

This is a Phase 2b, multinational, multicenter, randomized, double-blind, placebo controlled,
parallel group study to evaluate the efficacy and safety of three intravenous (IV) treatment
regimens of sifalimumab (200, 600, or 1,200 mg) in adult subjects with chronic
moderately-to-severely active SLE with an inadequate response to standard of care (SOC) for
SLE.

Inclusion Criteria: - Fulfills at least 4 of American College of Rheumatology (ACR)
criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody
(ANA) or elevated ds-deoxyribonucleic acid (DNA) or Sm antibody at screening - Disease
history of SLE greater than or equal to (>=) 24 weeks at screening - Weight more than (>)
40 kilogram (kg) - Currently receiving stable dose of oral prednisone and/or
antimalarials/immunosuppressives - Active moderate to severe SLE disease based on SLE
disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and
Physicians Global Assessment - No evidence of cervical malignancy on PAP within 6 months of
randomization - Female subjects must be willing to avoid pregnancy - Negative TB test or
newly positive TB test due to latent TB for which treatment must be initiated at or before
randomization. Exclusion Criteria: - Active severe SLE-driven renal disease or unstable
renal disease prior to screening - Active severe or unstable neuropsychiatric SLE -
Clinically significant active infection including ongoing and chronic infections - History
of human immunodeficiency virus (HIV) - Confirmed Positive tests for Hepatitis B or
positive test for hepatitis C - History of severe herpes infection such as herpes
encephalitis, ophthalmic herpes, disseminated herpes - Herpes Zoster within 3 months of
screening - History of cancer other than basal cancer or cervical cancer treated with
apparent success >=1 year prior to randomization - Receipt of a biologic agent within 5
half-lives or prior to loss of pharmacodynamic and/or clinical effect (whichever is longer)
prior to screening - Live or attenuated vaccine within 4 weeks prior to screening -
Subjects with substance abuse - Subjects with significant hematologic abnormalities.