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Completed

NCT Number: NCT00657007

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

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

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Belimumab

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

Other names: LymphoStat-B™, BENLYSTA

Placebo

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

Primary outcomes

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

    Time frame: Days 0-105

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Human Genome Sciences Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Apr 14, 2008
Registry last updated
Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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