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
  Purpose

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


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Belimumab 100 mg SC
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Human Genome Sciences Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 56
Study Start Date: October 2008
Study Completion Date: March 2012
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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™
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732940

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249-7201
United States, California
Valerious Medical Group Research Center
Long Beach, California, United States, 90806
United States, Florida
Tampa Medical Group, PA
Tampa, Florida, United States, 33614
United States, Michigan
Fiechtner Research, Inc.
Lansing, Michigan, United States, 48910
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
North Shore-LIJ Health System/Rheumatology, Allergy, Immunology
Lake Success, New York, United States, 11042
Rheumatology Associates
Smithtown, New York, United States, 11787
United States, Ohio
STAT Research, Inc.
Dayton, Ohio, United States, 45408
United States, Oklahoma
Oklahoma Center for Arthritis Therapy & Research
Tulsa, Oklahoma, United States, 74104
United States, Texas
Houston Institute for Clinical Research
Houston, Texas, United States, 77074
Mexico
Hospital Central "Igancio Morones Prieto"
San Lusi Potosi, Mexico, 78240
Sponsors and Collaborators
Human Genome Sciences Inc.
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00732940     History of Changes
Other Study ID Numbers: HGS1006-1070, 112232
Study First Received: August 8, 2008
Results First Received: April 7, 2011
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration
Mexico: Secretaria de Salud

Keywords provided by Human Genome Sciences Inc.:
SLE
Lupus
Systemic Lupus Erythematosus
Antibodies
Autoimmune Diseases
Belimumab

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014