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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00657007
• Date of registration: 08/04/2008
• Prospective Registration: No
• Primary sponsor: Human Genome Sciences Inc.
• Public title: Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
• Scientific 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
• Date of first enrolment: February 2002
• Target sample size: 70
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00657007
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: Placebo

Biological: belimumab

Primary Outcome(s)

To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE. [Time Frame: Days 0-105]

Secondary Outcome(s)

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]

Secondary ID(s)

Partial NIH grant M01 RR 00043

LBSL01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors