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

This study has been terminated.
(Sponsor terminated study for business reasons.)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT00732940
First received: August 8, 2008
Last updated: August 1, 2013
Last verified: March 2013

August 8, 2008
August 1, 2013
October 2008
October 2009   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
    SEE ALSO ADVERSE EVENTS RESULTS SECTION
  • Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24. [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Evaluations of frequency and rate of adverse events at weeks 12 and 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • The absolute and percent change from baseline in B-cells and B-cell subsets at weeks 12 and 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00732940 on ClinicalTrials.gov Archive Site
  • Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks. [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in IgA at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in IgA at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in IgG at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in IgG at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in IgM at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in IgM at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
    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.
  • Mean Percent Change From Baseline in PGA Score at Week 24. [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
    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.
  • Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
    SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.
  • Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in Complement C3 at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in Compliment C3 at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in Complement C4 at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in Complement C4 at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in Anti-dsDNA at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in HDL at Week 24 [ Time Frame: Baseline, 24 week ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in Total Cholesterol at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in Total Cholesterol at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Median Percent Change From Baseline in Triglycerides at Week 24 [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline in Triglycerides at Week 24 [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
  • Belimumab concentration levels (PK) following repeated subcutaneous administrations through week 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Absolute and percent change from baseline in serum immunoglobulins at weeks 12 and 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Absolute and percent change from baseline in Physician's Global Assessment score at weeks 12 and 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Absolute and percent change from baseline in the SELENA SLEDAI at weeks 12 and 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Absolute and percent change from baseline in the C3/C4, and anti-dsDNA at weeks 12 and 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in lipid profile (HDL, total cholesterol, triglycerides). [ Time Frame: 24 week ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Systemic Lupus Erythematosus
  • Drug: Belimumab 100 mg SC
    Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.
    Other Name: LymphoStat-B™
  • Drug: Belimumab 100 mg SC
    Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.
  • Experimental: Belimumab Q2WKS
    Every 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.
    Intervention: Drug: Belimumab 100 mg SC
  • Experimental: Belimumab 3X/WK
    Three 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.
    Intervention: Drug: Belimumab 100 mg SC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
56
March 2012
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Mexico
 
NCT00732940
HGS1006-1070, 112232
Yes
Human Genome Sciences Inc.
Human Genome Sciences Inc.
GlaxoSmithKline
Study Director: GSK Clinical Trials GlaxoSmithKline
Human Genome Sciences Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP