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Systemic Lupus ErythematosusPhase 2NCT00732940

Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 2 study testing Belimumab 100 mg SC in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc. at 11 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab 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 100 mg SC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
11 sitesin 2 countries
Study dates
Oct 2008to Mar 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 American College of Rheumatology (ACR) criteria
  • Active SLE disease
  • On stable SLE treatment regimen

Who cannot join

  • Pregnant or nursing
  • Have received treatment with an B cell targeted therapy
  • Have received treatment with a biologic investigational agent in the past year
  • Have received intravenous (IV) cyclophosphamide within 180 days of Day 0
  • Have severe lupus kidney disease
  • Have active central nervous system (CNS) lupus
Show all 10Show fewer
  • Have required management of acute or chronic infections with the past 60 days
  • Have current drug or alcohol abuse or dependence or within the past year
  • Have a historically positive test or test positive at screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Have a history of an allergic or anaphylactic reaction to drugs, food, or insects requiring medical intervention

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United States10 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249-7201

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • STAT Research, Inc.

    Dayton, Ohio, 45408

  • Houston Institute for Clinical Research

    Houston, Texas, 77074

  • North Shore-LIJ Health System/Rheumatology, Allergy, Immunology

    Lake Success, New York, 11042

  • Fiechtner Research, Inc.

    Lansing, Michigan, 48910

  • Valerious Medical Group Research Center

    Long Beach, California, 90806

  • Rheumatology Associates

    Smithtown, New York, 11787

  • Tampa Medical Group, PA

    Tampa, Florida, 33614

  • Oklahoma Center for Arthritis Therapy & Research

    Tulsa, Oklahoma, 74104

Other trials in United States

Mexico1 site

  • Hospital Central "Igancio Morones Prieto"

    San Lusi Potosi, 78240

Other trials in Mexico

About this study

Official title: A Phase 2, Multi-Center, Randomized, Open Label, Trial to Evaluate the Safety, Tolerability, and Biological Activity of 2 Dosing Schedules of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.

Read the detailed description

This clinical trial will evaluate the safety, pharmacokinetics (PK), and effect on biomarkers of repeated subcutaneous (SC) administration of belimumab in subjects with SLE. As data permit, an exploratory pharmacodynamic analysis will be performed to evaluate the correlation between belimumab serum exposure, PGA, SELENA SELDAI, and biomarker effects.

Being tested
Belimumab 100 mg SC
Keywords
SLE, Lupus, Systemic Lupus Erythematosus, Antibodies, Autoimmune Diseases, Belimumab
Medical subject headings
Lupus Erythematosus, Systemic, Autoimmune Diseases

What participants receive

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

  • Belimumab 100 mg SCDrug

    Also called LymphoStat-B™

    Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.

  • Belimumab 100 mg SCDrug

    Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.

Study groups in NCT00732940
Study groupRoleWhat they receive
Belimumab Q2WKSExperimentalEvery other week: 100 mg of belimumab (1 injection) subcutaneous (under the skin) on days 0, 7, and 14, then every other week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
Receives: Drug: Belimumab 100 mg SC
Belimumab 3X/WKExperimentalThree times weekly: 200 mg of belimumab (2 injections of 100 mg each) subcutaneous (under the skin) on days 0, 2, and 4 then 100 mg three times a week until final evaluation at Week 24 with option to continue receiving belimumab at the same dose through 144 week continuation period.
Receives: Drug: Belimumab 100 mg SC

What is being measured

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

  1. Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.

    SEE ALSO ADVERSE EVENTS RESULTS SECTION

    Measured: Up to 24 weeks

  2. Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24

    Measured: Baseline, 24 weeks

  3. Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.

    Measured: Baseline, 24 Weeks

  4. Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24

    Measured: Baseline, 24 weeks

  5. Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24

    Measured: Baseline, 24 weeks

  6. Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24

    Measured: Baseline, 24 Weeks

  7. Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24

    Measured: Baseline, 24 Weeks

  8. Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24

    Measured: Baseline, 24 Weeks

  9. Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24

    Measured: Baseline, 24 Weeks

Secondary outcomes (23)

  1. Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.

    Measured: Baseline, 24 weeks

  2. Absolute Change From Baseline in IgA at Week 24

    Measured: Baseline, 24 Weeks

  3. Median Percent Change From Baseline in IgA at Week 24

    Measured: Baseline, 24 weeks

  4. Absolute Change From Baseline in IgG at Week 24

    Measured: Baseline, 24 Weeks

  5. Median Percent Change From Baseline in IgG at Week 24

    Measured: Baseline, 24 Weeks

  6. Absolute Change From Baseline in IgM at Week 24

    Measured: Baseline, 24 Weeks

  7. Median Percent Change From Baseline in IgM at Week 24

    Measured: Baseline, 24 weeks

  8. Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24

    PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.

    Measured: Baseline, 24 Weeks

  9. Mean Percent Change From Baseline in PGA Score at Week 24.

    The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.

    Measured: Baseline, 24 weeks

  10. Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24

    SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.

    Measured: Baseline, 24 Weeks

  11. Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24

    Measured: Baseline, 24 weeks

  12. Absolute Change From Baseline in Complement C3 at Week 24

    Measured: Baseline, 24 Weeks

  13. Median Percent Change From Baseline in Compliment C3 at Week 24

    Measured: Baseline, 24 Weeks

  14. Absolute Change From Baseline in Complement C4 at Week 24

    Measured: Baseline, 24 weeks

  15. Median Percent Change From Baseline in Complement C4 at Week 24

    Measured: Baseline, 24 Weeks

  16. Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24

    Measured: Baseline, 24 Weeks

  17. Median Percent Change From Baseline in Anti-dsDNA at Week 24

    Measured: Baseline, 24 weeks

  18. Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24

    Measured: Baseline, 24 Weeks

  19. Median Percent Change From Baseline in HDL at Week 24

    Measured: Baseline, 24 week

  20. Absolute Change From Baseline in Total Cholesterol at Week 24

    Measured: Baseline, 24 Weeks

  21. Median Percent Change From Baseline in Total Cholesterol at Week 24

    Measured: Baseline, 24 Weeks

  22. Median Percent Change From Baseline in Triglycerides at Week 24

    Measured: Baseline, 24 weeks

  23. Absolute Change From Baseline in Triglycerides at Week 24

    Measured: Baseline, 24 Weeks

Timeline

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

  1. First posted12 Aug 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionOct 2009
  4. Study completionMar 2012

Why it stopped: Sponsor terminated study for business reasons.

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00732940
Sponsor's protocol ID
HGS1006-1070
Other IDs
112232
Status last verified
Mar 2013
First submitted
8 Aug 2008
Last updated
7 Aug 2013
Data monitoring committee
Yes

Publications

  • van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.

    PubMed 31302695

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Belimumab 100 mg SC in people with Systemic Lupus Erythematosus, run by Human Genome Sciences Inc. at 11 sites in 2 countries.

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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 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 11 sites in United States, Mexico. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. (time frame: Up to 24 weeks). The study lists 9 primary outcomes in all. 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 NCT00732940, which also lists 1 linked publication.

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 7 Aug 2013.

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