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 seropositive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA-SLEDAI score ≥10, and positive for anti-double stranded DNA and low complement (C3 or C4).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3
Administered via subcutaneous injection once per week
Administered via subcutaneous injection once per week
Investigator Site 004
Tbilisi, Georgia
Investigator Site 001
Tbilisi, Georgia
Investigator Site 002
Tbilisi, Georgia
Proportion of responders to the SRI-6 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 to ≤ 7.5 mg
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 counts, anti-dsDNA, C3, C4
Time frame: Through week 52
Number of adverse events
Time frame: Through week 52
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