Systemic Lupus Erythematosus
Conditions
Keywords
SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod, Nephritis
Brief 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.
Interventions
DRUGBlisibimod
Administered via subcutaneous injection once per week
DRUGPlacebo
Administered via subcutaneous injection once per week
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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of responders to the SRI-8 composite responder index | 52 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to first severe SLE flare | Baseline through 52 weeks |
| Change in the number of actively tender or swollen joints and in mucocutaneous disease activity | 52 Weeks |
| Change in proteinuria from baseline | Week 52 |
| Proportion of subjects able to reduce oral steroid dose | Baseline through 52 weeks |
| Time to treatment failure | Through week 52 |
| Change from baseline in B cell subsets, anti-dsDNA, C3, C4 | Through week 52 |
| Safety profile (AEs, vital signs, labs, physical exams) | Through week 52 |
| Proportion of subjects with improved patient-reported outcomes | Week 52 |
Other
| Measure | Time frame |
|---|---|
| Subgroup analyses of blisibimod effect in subjects with renal manifestations at baseline | 52 Weeks |
Outcome results
None listed