A Phase 1, Multi-Center, Double-Blind, Single and Double Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus

Human Genome Sciences Inc.18 sites in 1 country70 target enrollmentFebruary 2002

ConditionsSystemic Lupus Erythematosus

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Systemic Lupus Erythematosus
Sponsor: Human Genome Sciences Inc.
Enrollment: 70
Locations: 18
Primary Endpoint: To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.

Registry

clinicaltrials.gov

Start Date

February 2002

End Date

March 2003

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Human Genome Sciences Inc.

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of SLE by ACR criteria
•Stable SLE disease activity
•On stable SLE treatment regimen
•History of measurable autoantibodies

Exclusion Criteria

•Pregnant or nursing
•Received a non-FDA approved investigational agent within last 28 days
•Received cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 6 months
•Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan™), or high-dose prednisone (\> 100 mg/day) within last 6 months
•Active central nervous system (CNS) lupus requiring medical intervention within last 6 months
•History of renal transplant
•History of clinical evidence of an active significant acute or chronic diseases
•Have required management or hospitalization of any infection within last 4 weeks.
•History of hypogammaglobulinemia or IgA deficiency
•Have current drug or alcohol addiction

Outcomes

Primary Outcomes

To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE.

Time Frame: Days 0-105

Secondary Outcomes

To evaluate the effect of belimumab on clinical disease activity, total serum IgG (and IgM, IgA, IgE) and concentrations of peripheral mature B lymphocytes and plasmacytoid cells, and markers of SLE disease activity, including autoantibodies.(Days 0-105)