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

Anthera Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Other: Placebo Comparator; Drug: A-623

Study type: Interventional

Funder types: Industry

Identifiers

NCT01162681

AN-SLE3321

Details and patient eligibility

About

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

Enrollment: 547 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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547 participants in 4 patient groups, including a placebo group

A-623 high dose weekly

Experimental group

Treatment:

Drug: A-623

Drug: A-623

Drug: A-623

A-623 low dose weekly

Experimental group

Treatment:

Drug: A-623

Drug: A-623

Drug: A-623

A-623 high dose every 4 weeks

Experimental group

Treatment:

Drug: A-623

Drug: A-623

Drug: A-623

Placebo

Placebo Comparator group

Treatment:

Other: Placebo Comparator