NCT00657007CompletedPhase 1
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
Human Genome Sciences Inc.18 sites in 1 country70 target enrollmentStarted: February 1, 2002Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Human Genome Sciences Inc.
- Enrollment
- 70
- Locations
- 18
- Primary Endpoint
- To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of SLE by ACR criteria
- •Stable SLE disease activity
- •On stable SLE treatment regimen
- •History of measurable autoantibodies
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
Arms & Interventions
Placebo
Placebo Comparator
IV infusion over 2 hours
Intervention: Placebo (Biological)
Belimumab 4 mg/kg
Experimental
4 mg/kg IV infused over 2 hours
Intervention: belimumab (Biological)
Belimumab 20 mg/kg
Experimental
20 mg/kg IV infused over 2 hours
Intervention: belimumab (Biological)
Beimumab 10 mg/kg
Experimental
10 mg/kg IV infused over 2 hours
Intervention: belimumab (Biological)
Belimumab 1 mg/kg
Experimental
1 mg/kg IV infused over 2 hours
Intervention: belimumab (Biological)
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.(Days 0-105)
Investigators
Study Sites (18)
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