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, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease
Interventions
DRUGA-623
High dose given subcutaneously once a week for up to 52 weeks
OTHERPlacebo Comparator
Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks
Sponsors
Anthera Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of SLE by American College of Rheumatology guidelines. * On stable SLE treatment * Active SLE disease * Serologically active * 18 years of age or older * Receiving stable doses of prednisone between 7.5 mg and 40 mg per day
Exclusion criteria
* Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes. * 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. * Malignancy within past 5 years * 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. * Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months. * Prior administration of any B cell depleting therapy in the past 18 months. * Pregnant or nursing * History of congenital immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SLE response | Various timepoints through Week 52 | The % of subjects with SLE response compared with baseline at the time of assessment |
Secondary
| Measure | Time frame |
|---|---|
| Time to first flare | Various timepoints through Week 52 |
| FACIT-fatigue score | Various timepoints through Week 52 |
| Reduction in prednisone dose | Various timepoints through Week 52 |
| B cell reduction | Various timepoints through Week 52 |
| Flare rates | Various timepoints through Week 52 |
| SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9 | Various timepoints through Week 52 |
| Change in IgG, IgM,C3 and C4 | Various timepoints through Week 52 |
Countries
Argentina, Brazil, Chile, Colombia, Hong Kong, India, Mexico, Peru, Philippines, Taiwan, United States
Outcome results
None listed