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Systemic Lupus ErythematosusPhase 1NCT00657007

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

A Phase 1 study testing belimumab in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc. at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
belimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
18 sitesUnited States
Study dates
Feb 2002to Mar 2003
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of SLE by ACR criteria
  • Stable SLE disease activity
  • On stable SLE treatment regimen
  • History of measurable autoantibodies

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • The University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University Medical School

    Chicago, Illinois, 60611

  • Rush-Presbyterian-St Luke's Medical Center

    Chicago, Illinois, 60612

  • The University of Chicago Hospital

    Chicago, Illinois, 60637

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Duke University

    Durham, North Carolina, 27710

  • University of Southern California

    Los Angeles, California, 90033

  • University of California-Los Angeles

    Los Angeles, California, 90095

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Hospital for Joint Diseases

    New York, New York, 10003

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15261

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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

Being tested
belimumab, Placebo
Keywords
lupus, SLE
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • belimumabBiological

    Also called LymphoStat-B™, BENLYSTA

    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).

  • belimumabBiological

    Also called LymphoStat-B™, BENLYSTA

    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).

  • belimumabBiological

    Also called LymphoStat-B™, BENLYSTA

    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).

  • belimumabBiological

    Also called LymphoStat-B™, BENLYSTA

    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).

  • PlaceboBiological

    1. IV (in the vein) on Day 0 (Cohorts 1-4).
    2. IV (in the vein) on Days 0 and 21 (Cohorts 5-8).
Study groups in NCT00657007
Study groupRoleWhat they receive
PlaceboPlacebo comparatorIV infusion over 2 hours
Receives: Biological: Placebo
Belimumab 1 mg/kgExperimental1 mg/kg IV infused over 2 hours
Receives: Biological: belimumab
Belimumab 4 mg/kgExperimental4 mg/kg IV infused over 2 hours
Receives: Biological: belimumab
Beimumab 10 mg/kgExperimental10 mg/kg IV infused over 2 hours
Receives: Biological: belimumab
Belimumab 20 mg/kgExperimental20 mg/kg IV infused over 2 hours
Receives: Biological: belimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Days 0-105

Secondary outcomes (1)

  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.

    Measured: Days 0-105

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2008 (estimated)
  2. Study startFeb 2002
  3. Primary completionMar 2003
  4. Study completionMar 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00657007
Sponsor's protocol ID
LBSL01
Other IDs
Partial NIH grant M01 RR 00043
Status last verified
Aug 2013
First submitted
8 Apr 2008
Last updated
2 Aug 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34741731

  • 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.

    PubMed 34628605

  • 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.

    PubMed 23681782

  • 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.

    PubMed 18786258

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing belimumab in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc. at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of belimumab in subjects with SLE. (time frame: Days 0-105). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00657007, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.

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