Systemic Lupus Erythematosus
Conditions
Keywords
SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod
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.
Interventions
DRUGblisibimod
blisibimod administered via subcutaneous injection every week for 52 weeks
DRUGPlacebo
Placebo will be administered weekly via subcutaneous injection for 52 weeks
Sponsors
Anthera Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving an SLE Responder Index at week 52 | Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Change in proteinuria from baseline | Week 52 |
| Proportion of subjects with improved patient-reported outcomes | Week 52 |
| Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone | Week 52 |
| Time to first severe SLE flare | Week 52 |
| Change in the number of actively tender or swollen joints and in mucocutaneous disease activity | Week 52 |
| Time to first renal flare | Week 52 |
| Change from baseline in B cell subsets, anti dsDNA, C3, C4 | Week 52 |
| Safety Profile (AEs, vital signs, labs, physical exams) | Week 52 |
| Time to treatment failure | Week 52 |
Countries
Belarus, Brazil, Colombia, Georgia, Guatemala, Hong Kong, India, Malaysia, Mexico, Philippines, Russia, Singapore, South Korea, Sri Lanka, Taiwan, Thailand
Outcome results
None listed