| A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) |
| A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE) |
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active SLE disease. |
The purpose of this SLE trial study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| At Wk52, the percent of subjects with ≥ 4 point reduction from baseline in SELENA SLEDAI score and no worsening in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ] |
At Wk 76, percent of subjects with ≥4 point reduction from baseline in SELENA SLEDAI score and no worsening in (PGA) and no new BILAG organ domain score or 2 new BILAG organ domain scores compared with baseline at the time of assessment. [ Time Frame: 76 Weeks ] [ Designated as safety issue: No ]
Percent of subjects with ≥4 point reduction from baseline in SELENA SLEDAI score at Wk 52. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
Mean change in PGA at Wk 24. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Mean change in SF-36 Health Survey physical component summary score (PCS) at Wk 24. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Percent of subjects whose average prednisone dose has been reduced by greater than or equal to 25% from baseline to less than or equal to 7.5 mg/day during Weeks 40 through 52 [ Time Frame: Weeks 40-52 ] [ Designated as safety issue: No ] |
| Systemic Lupus Erythematosus |
Drug: belimumab
Drug: Placebo |
|
www.bliss-study.com  |
|
| Recruiting |
| 810 |
| December 2006 |
| June 2009 |
Key Inclusion Criteria:
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- On stable SLE treatment regimen.
Key Exclusion Criteria:
- Pregnant or nursing
- Have received treatment with any B cell targeted therapy.
- Have received treatment with a biological investigational agent in the past year.
- Have received 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 within the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
|
| Both |
| 18 Years and older |
| No |
|
|
| United States, Austria, Belgium, Canada, Costa Rica, Czech Republic, France, Germany, Israel, Italy, Mexico, Netherlands, Poland, Puerto Rico, Slovakia, Spain, Sweden, United Kingdom |
|
| NCT00410384 |
| HGS1006-C1056 |
| BLISS-76 |
| Human Genome Sciences |
| GlaxoSmithKline |
| Study Director: |
William Freimuth, MD, PhD |
Human Genome Sciences, Inc. |
|
|
| Human Genome Sciences |
| April 2008 |
| December 8, 2006 |
| August 7, 2008 |
