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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
belimumab
belimumab
belimumab
belimumab
Placebo
Sponsored by
Human Genome Sciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring lupus, SLE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • University of Southern California
  • University of California-Los Angeles
  • Washington Hospital Center
  • Northwestern University Medical School
  • Rush-Presbyterian-St Luke's Medical Center
  • The University of Chicago Hospital
  • The University of Michigan Health System
  • SUNY Downstate Medical Center
  • North Shore University Hospital
  • Hospital for Joint Diseases
  • The University of North Carolina at Chapel Hill
  • Duke University
  • Wake Forest University School of Medicine
  • Oklahoma Medical Research Foundation
  • University of Pittsburgh School of Medicine
  • Medical University of South Carolina
  • University of Texas Southwestern Medical Center at Dallas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Belimumab 1 mg/kg

Belimumab 4 mg/kg

Beimumab 10 mg/kg

Belimumab 20 mg/kg

Arm Description

IV infusion over 2 hours

1 mg/kg IV infused over 2 hours

4 mg/kg IV infused over 2 hours

10 mg/kg IV infused over 2 hours

20 mg/kg IV infused over 2 hours

Outcomes

Primary Outcome Measures

To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE.

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.

Full Information

First Posted
April 8, 2008
Last Updated
August 1, 2013
Sponsor
Human Genome Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00657007
Brief Title
Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Human Genome Sciences Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
lupus, SLE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
IV infusion over 2 hours
Arm Title
Belimumab 1 mg/kg
Arm Type
Experimental
Arm Description
1 mg/kg IV infused over 2 hours
Arm Title
Belimumab 4 mg/kg
Arm Type
Experimental
Arm Description
4 mg/kg IV infused over 2 hours
Arm Title
Beimumab 10 mg/kg
Arm Type
Experimental
Arm Description
10 mg/kg IV infused over 2 hours
Arm Title
Belimumab 20 mg/kg
Arm Type
Experimental
Arm Description
20 mg/kg IV infused over 2 hours
Intervention Type
Biological
Intervention Name(s)
belimumab
Other Intervention Name(s)
LymphoStat-B™, BENLYSTA
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
belimumab
Other Intervention Name(s)
LymphoStat-B™, BENLYSTA
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
belimumab
Other Intervention Name(s)
LymphoStat-B™, BENLYSTA
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
belimumab
Other Intervention Name(s)
LymphoStat-B™, BENLYSTA
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
IV (in the vein) on Day 0 (Cohorts 1-4). IV (in the vein) on Days 0 and 21 (Cohorts 5-8).
Primary Outcome Measure Information:
Title
To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE.
Time Frame
Days 0-105
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California-Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Northwestern University Medical School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush-Presbyterian-St Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Chicago Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Hospital for Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pittsburgh School of Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34741731
Citation
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.
Results Reference
derived
PubMed Identifier
34628605
Citation
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.
Results Reference
derived
PubMed Identifier
23681782
Citation
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.
Results Reference
derived
PubMed Identifier
18786258
Citation
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.
Results Reference
derived

Learn more about this trial

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

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