CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus

• Time to first severe SLE flare [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
• Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
• Change in the number of actively tender or swollen joints and in mucocutaneous disease activity [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
• Change in proteinuria from baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
• Proportion of subjects with improved patient-reported outcomes [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
• Time to treatment failure [ Time Frame: Through Week 52 ] [ Designated as safety issue: No ]
• Change from baseline in B cell subsets, anti dsDNA, C3, C4 [ Time Frame: Through Week 52 ] [ Designated as safety issue: No ]
• Safety profile (AEs, vital signs, labs, physical exams) [ Time Frame: Through Week 52 ] [ Designated as safety issue: Yes ]

• Time to first severe SLE flare (SFI) [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
• Time to treatment failure [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
• Proportion of subjects with improved Physicians Global Assessment (PGA) score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
• Proportion of subjects able to decrease dose of prednisone [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
• Proportion of subjects with improved SF-36 scores [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

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.

• Drug: blisibimod
  blisibimod administered via subcutaneous injection every week for 52 weeks
• Drug: Placebo
  Placebo will be administered weekly via subcutaneous injection for 52 weeks

• Experimental: blisibimod weekly dose
  Intervention: Drug: blisibimod
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Inclusion Criteria:

• Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology
• Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)
• Active SLE disease as defined by the appropriate SELENA-SLEDAI score
• On stable SLE treatment including corticosteroid
• 18 years of age or older

Exclusion Criteria:

• Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension or poorly controlled diabetes
• Malignancy within past 5 years
• Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
• Liver disease
• Anemia, neutropenia, or thrombocytopenia
• Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
• History of active tuberculosis or a history of tuberculosis infection
• Pregnant or nursing