Trial | NCT00657007  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    belimumab ...

  • Study Participants

    70
The purpose of thie study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab (LymphoStat-B™)in subjects with SLE.
Study Started
Feb 28
2002
Primary Completion
Mar 31
2003
Study Completion
Mar 31
2003
Last Update
Aug 02
2013
Estimate

Biological belimumab

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

Biological belimumab

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

  • Other names: LymphoStat-B™, BENLYSTA

Biological belimumab

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

  • Other names: LymphoStat-B™, BENLYSTA

Biological belimumab

20 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 4). 20 mg/kg, IV (in the vein) on Days 0 and 21, with a final evaluation at Day 105 (Cohort 8).

  • Other names: LymphoStat-B™, BENLYSTA

Biological Placebo

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

Placebo Placebo Comparator

IV infusion over 2 hours

Belimumab 1 mg/kg Experimental

1 mg/kg IV infused over 2 hours

Belimumab 4 mg/kg Experimental

4 mg/kg IV infused over 2 hours

Beimumab 10 mg/kg Experimental

10 mg/kg IV infused over 2 hours

Belimumab 20 mg/kg Experimental

20 mg/kg IV infused over 2 hours

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
No Results Posted