Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT00657007
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
70 participants
INTERVENTIONAL
2002-02-28
2003-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
IV infusion over 2 hours
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).
Belimumab 1 mg/kg
1 mg/kg IV infused over 2 hours
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).
Belimumab 4 mg/kg
4 mg/kg IV infused over 2 hours
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).
Beimumab 10 mg/kg
10 mg/kg IV infused over 2 hours
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).
Belimumab 20 mg/kg
20 mg/kg IV infused over 2 hours
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).
Interventions
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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).
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).
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).
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).
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable SLE disease activity
* On stable SLE treatment regimen
* History of measurable autoantibodies
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Human Genome Sciences Inc.
INDUSTRY
Responsible Party
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Human Genome Sciences, Inc.
Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
University of California-Los Angeles
Los Angeles, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, 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
The University of Michigan Health System
Ann Arbor, Michigan, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Hospital for Joint Diseases
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Countries
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References
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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.
Zhou 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.
Struemper 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.
Furie 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.
Other Identifiers
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Partial NIH grant M01 RR 00043
Identifier Type: -
Identifier Source: secondary_id
LBSL01
Identifier Type: -
Identifier Source: org_study_id