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 seropositive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA-SLEDAI score ≥10, and positive for anti-double stranded DNA and low complement (C3 or C4).
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 * Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy * Positive for anti-double stranded DNA (anti-dsDNA) and low complement * Subjects with stable nephritis may be enrolled * 18 years of age or older
Exclusion criteria
* Severe active central nervous system lupus * Malignancy within past 5 years * Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C * Comorbidities that would interfere with evaluations of study drug effect * 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-6 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 to ≤ 7.5 mg | Baseline through 52 weeks |
| Time to treatment failure | Through week 52 |
| Change from baseline in B cell counts, anti-dsDNA, C3, C4 | Through week 52 |
| Number of adverse events | Through week 52 |
| Proportion of subjects with improved patient-reported outcomes | Week 52 |
Other
| Measure | Time frame |
|---|---|
| Occurrence of renal flare in subjects with renal manifestations at baseline | 52 Weeks |
Countries
Georgia
Outcome results
None listed