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

Systemic Lupus Erythematosus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657007
• Other study ID #: LBSL01
• Secondary ID: Partial NIH gran
• Status: Completed
• Phase: Phase 1
• First received: April 8, 2008
• Last updated: August 1, 2013
• Start date: February 2002
• Est. completion date: March 2003

Study information

• Verified date: August 2013
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
United States	The University of Michigan Health System	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University Medical School	Chicago	Illinois
United States	Rush-Presbyterian-St Luke's Medical Center	Chicago	Illinois
United States	The University of Chicago Hospital	Chicago	Illinois
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	University of California-Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Hospital for Joint Diseases	New York	New York
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania
United States	Washington Hospital Center	Washington	District of Columbia
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE.		Days 0-105	Yes
Secondary	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	Yes