The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score ≥10.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Administered via subcutaneous injection once per week
Administered via subcutaneous injection once per week
Proportion of responders to the SRI-8 composite responder index
Time frame: 52 Weeks
Time to first severe SLE flare
Time frame: Baseline through 52 weeks
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
Time frame: 52 Weeks
Change in proteinuria from baseline
Time frame: Week 52
Proportion of subjects able to reduce oral steroid dose
Time frame: Baseline through 52 weeks
Proportion of subjects with improved patient-reported outcomes
Time frame: Week 52
Time to treatment failure
Time frame: Through week 52
Change from baseline in B cell subsets, anti-dsDNA, C3, C4
Time frame: Through week 52
Safety profile (AEs, vital signs, labs, physical exams)
Time frame: Through week 52
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