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

August 1, 2013 updated by: Human Genome Sciences Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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
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
Experimental: Belimumab 4 mg/kg
4 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
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
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
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
Experimental: Beimumab 10 mg/kg
10 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
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
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
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
Experimental: Belimumab 20 mg/kg
20 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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE.
Time Frame: Days 0-105
Days 0-105

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Days 0-105

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Human Genome Sciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 8, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBSL01
  • Partial NIH grant M01 RR 00043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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