The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
442
blisibimod administered via subcutaneous injection every week for 52 weeks
Placebo will be administered weekly via subcutaneous injection for 52 weeks
Proportion of patients achieving an SLE Responder Index at week 52
Time frame: Week 52
Time to first severe SLE flare
Time frame: Week 52
Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone
Time frame: Week 52
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
Time frame: Week 52
Change in proteinuria from baseline
Time frame: Week 52
Proportion of subjects with improved patient-reported outcomes
Time frame: Week 52
Time to treatment failure
Time frame: Week 52
Time to first renal flare
Time frame: Week 52
Change from baseline in B cell subsets, anti dsDNA, C3, C4
Time frame: Week 52
Safety Profile (AEs, vital signs, labs, physical exams)
Time frame: Week 52
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Homyel, Belarus
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Minsk, Belarus
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Minsk, Belarus
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Vitebsk, Belarus
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Curitiba, Brazil
Investigator Site 555
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Investigator Site 557
Juiz de Fora, Brazil
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Porto Alegre, Brazil
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