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
2 other identifiers
interventional
70
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2002
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 8, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedAugust 2, 2013
August 1, 2013
1.1 years
April 8, 2008
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE.
Days 0-105
Secondary Outcomes (1)
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
Study Arms (5)
Placebo
PLACEBO COMPARATORIV infusion over 2 hours
Belimumab 1 mg/kg
EXPERIMENTAL1 mg/kg IV infused over 2 hours
Belimumab 4 mg/kg
EXPERIMENTAL4 mg/kg IV infused over 2 hours
Beimumab 10 mg/kg
EXPERIMENTAL10 mg/kg IV infused over 2 hours
Belimumab 20 mg/kg
EXPERIMENTAL20 mg/kg IV infused over 2 hours
Interventions
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).
1. IV (in the vein) on Day 0 (Cohorts 1-4). 2. IV (in the vein) on Days 0 and 21 (Cohorts 5-8).
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of SLE by ACR criteria
- Stable SLE disease activity
- On stable SLE treatment regimen
- History of measurable autoantibodies
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Southern California
Los Angeles, California, 90033, United States
University of California-Los Angeles
Los Angeles, California, 90095, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Northwestern University Medical School
Chicago, Illinois, 60611, United States
Rush-Presbyterian-St Luke's Medical Center
Chicago, Illinois, 60612, United States
The University of Chicago Hospital
Chicago, Illinois, 60637, United States
The University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Hospital for Joint Diseases
New York, New York, 10003, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27710, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15261, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Related Publications (4)
Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
PMID: 34741731DERIVEDZhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.
PMID: 34628605DERIVEDStruemper H, Chen C, Cai W. Population pharmacokinetics of belimumab following intravenous administration in patients with systemic lupus erythematosus. J Clin Pharmacol. 2013 Jul;53(7):711-20. doi: 10.1002/jcph.104. Epub 2013 May 16.
PMID: 23681782DERIVEDFurie R, Stohl W, Ginzler EM, Becker M, Mishra N, Chatham W, Merrill JT, Weinstein A, McCune WJ, Zhong J, Cai W, Freimuth W; Belimumab Study Group. Biologic activity and safety of belimumab, a neutralizing anti-B-lymphocyte stimulator (BLyS) monoclonal antibody: a phase I trial in patients with systemic lupus erythematosus. Arthritis Res Ther. 2008;10(5):R109. doi: 10.1186/ar2506. Epub 2008 Sep 11.
PMID: 18786258DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 8, 2008
First Posted
April 14, 2008
Study Start
February 1, 2002
Primary Completion
March 1, 2003
Study Completion
March 1, 2003
Last Updated
August 2, 2013
Record last verified: 2013-08