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:
Human Genome Sciences Inc., a GSK Company
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00732940
First received: August 8, 2008
Last updated: March 11, 2013
Last verified: March 2013
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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 GlaxoSmithKline:
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
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., a GSK Company
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ) |
| ClinicalTrials.gov Identifier: | NCT00732940 History of Changes |
| Other Study ID Numbers: | 112232, HGS1006-1070 |
| Study First Received: | August 8, 2008 |
| Results First Received: | April 7, 2011 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Food and Drug Administration Mexico: Secretaria de Salud |
Keywords provided by GlaxoSmithKline:
|
SLE Lupus Systemic Lupus Erythematosus |
Antibodies Autoimmune Diseases Belimumab |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013