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

This study has been completed.
Sponsor:
Information provided by:
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT00657007
First received: April 8, 2008
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Systemic Lupus Erythematosus
Biological: belimumab
Biological: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Human Genome Sciences Inc.:

Primary Outcome Measures:
  • To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE. [ Time Frame: Days 0-105 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: February 2002
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
IV infusion over 2 hours
Biological: Placebo
  1. IV (in the vein) on Day 0 (Cohorts 1-4).
  2. IV (in the vein) on Days 0 and 21 (Cohorts 5-8).
Experimental: Belimumab 1 mg/kg
1 mg/kg IV infused over 2 hours
Biological: belimumab
  1. 1 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 1).
  2. 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
Experimental: Belimumab 4 mg/kg
4 mg/kg IV infused over 2 hours
Biological: belimumab
  1. 4 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 2).
  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
Experimental: Beimumab 10 mg/kg
10 mg/kg IV infused over 2 hours
Biological: belimumab
  1. 10 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 3).
  2. 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
Experimental: Belimumab 20 mg/kg
20 mg/kg IV infused over 2 hours
Biological: belimumab
  1. 20 mg/kg, IV (in the vein) once on Day 0, with a final evaluation at Day 84 (Cohort 4).
  2. 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657007

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California-Los Angeles
Los Angeles, California, United States, 90095
University of Southern California
Los Angeles, California, United States, 90033
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Illinois
The University of Chicago Hospital
Chicago, Illinois, United States, 60637
Rush-Presbyterian-St Luke's Medical Center
Chicago, Illinois, United States, 60612
Northwestern University Medical School
Chicago, Illinois, United States, 60611
United States, Michigan
The University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
North Shore University Hospital
Manhasset, New York, United States, 11030
Hospital for Joint Diseases
New York, New York, United States, 10003
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27710
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15261
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Human Genome Sciences Inc.
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by Human Genome Sciences Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Freimuth, MD, PhD/Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases, Human Genome Sciences, Inc.
ClinicalTrials.gov Identifier: NCT00657007     History of Changes
Other Study ID Numbers: LBSL01, Partial NIH grant M01 RR 00043
Study First Received: April 8, 2008
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Human Genome Sciences Inc.:
lupus
SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014