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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00657007

Enrollment

Registered

2008-04-14

Start date

2002-02-28

Completion date

2003-03-31

Last updated

2013-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

lupus, SLE

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.

Interventions

BIOLOGICALbelimumab

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).

BIOLOGICALPlacebo

1. IV (in the vein) on Day 0 (Cohorts 1-4). 2. IV (in the vein) on Days 0 and 21 (Cohorts 5-8).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE.	Days 0-105

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026