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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anthera Pharmaceuticals

Criteria

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