NCT01162681
Completed
Phase 2
A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
Overview
- Phase
- Phase 2
- Intervention
- A-623
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- Anthera Pharmaceuticals
- Enrollment
- 547
- Locations
- 74
- Primary Endpoint
- SLE response
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
A-623 high dose weekly
Intervention: A-623
A-623 low dose weekly
Intervention: A-623
A-623 high dose every 4 weeks
Intervention: A-623
Placebo
Intervention: Placebo Comparator
Outcomes
Primary Outcomes
SLE response
Time Frame: Various timepoints through Week 52
The % of subjects with SLE response compared with baseline at the time of assessment
Secondary Outcomes
- Reduction in prednisone dose(Various timepoints through Week 52)
- Time to first flare(Various timepoints through Week 52)
- SRI, using improvements of SELENA-SLEDAI of 5, 6, 7, 8 and 9(Various timepoints through Week 52)
- B cell reduction(Various timepoints through Week 52)
- FACIT-fatigue score(Various timepoints through Week 52)
- Change in IgG, IgM,C3 and C4(Various timepoints through Week 52)
- Flare rates(Various timepoints through Week 52)
Study Sites (74)
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