Contact Information
Project Manager:
Georgina Kilfoil
Anthera Pharmaceuticals, Inc.
T: 510.856.5578
F: 510-856-5597
E: gkilfoil@anthera.com
A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus
Sponsor
Anthera Pharmaceuticals, Inc.
25801 Industrial Blvd
Hayward, CA 94545
USA
Purpose
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
Study Design
A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus. Subjects will be randomized to receive subcutaneous doses of A-623 (at one of 3 dose levels) or placebo for up to 52 weeks.
All enrolled subjects will be allowed to continue his or her standard-of-care oral medications for treatment of SLE throughout the study. SLE disease activity and management will be monitored and recorded throughout the study. The primary objective of this study is to evaluate the clinical efficacy of A-623 as measured by the systemic lupus erythematosus (SLE) responder index (SRI) in subjects with serologically active SLE. The SRI is defined as >4 point improvement in the Safety of Estrogen in Lupus Erythematosus National Assessment – Systematic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score AND no new British Isles Lupus Activity Guide (BILAG) 1A or 2B organ domain flares AND no worsening in Physician’s Global Assessment (PGA) (<0.3 point increase). Additional assessments of time to first SLE flare, FACIT-fatigue score, reduction in prednisone dose, and biomarker changes including B cell counts, will be made.
Total Enrollment
600
Location
Worldwide
Eligibility
Patients are eligible for inclusion if they meet the following criteria:
- Men and women > 18 years of age
- Diagnosis of SLE by American College of Rheumatology guidelines.
- On stable SLE treatment
- Active SLE disease
- Serologically active
- Receiving stable doses of prednisone between 7.5 mg and 40 mg per day
Exclusion Criteria
Patients must not meet any of the following (principal) 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
