Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

Human Genome Sciences Inc.70 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

belimumabBIOLOGICAL

1. 1 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 1). 2. 1 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 5).

belimumabBIOLOGICAL

1. 4 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 2). 2. 4 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 6).

belimumabBIOLOGICAL

1. 10 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 3). 2. 10 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 7).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Clinical diagnosis of SLE by ACR criteria * Stable SLE disease activity * On stable SLE treatment regimen * History of measurable autoantibodies Key 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 * History of or test positive at screening for HIV, Hepatitis B or Hepatitis C

Locations (18)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Southern California

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.

Time frame: Days 0-105

Data from ClinicalTrials.gov

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