CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

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.

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 SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy
• Subjects with stable nephritis may be enrolled
• 18 years of age or older

Exclusion Criteria:

• Severe active vasculitis, active central nervous system lupus, 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