PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anthera Pharmaceuticals

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

• History of congenital immunodeficiency