NCT01395745
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus
Overview
- Phase
- Phase 3
- Intervention
- blisibimod
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- Anthera Pharmaceuticals
- Enrollment
- 442
- Locations
- 90
- Primary Endpoint
- Proportion of patients achieving an SLE Responder Index at week 52
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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 as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy.
Investigators
Eligibility 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
- •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
Arms & Interventions
blisibimod weekly dose
Intervention: blisibimod
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of patients achieving an SLE Responder Index at week 52
Time Frame: Week 52
Secondary Outcomes
- Time to first severe SLE flare(Week 52)
- Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone(Week 52)
- Change in the number of actively tender or swollen joints and in mucocutaneous disease activity(Week 52)
- Change in proteinuria from baseline(Week 52)
- Safety Profile (AEs, vital signs, labs, physical exams)(Week 52)
- Time to first renal flare(Week 52)
- Change from baseline in B cell subsets, anti dsDNA, C3, C4(Week 52)
- Proportion of subjects with improved patient-reported outcomes(Week 52)
- Time to treatment failure(Week 52)
Study Sites (90)
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