Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)
- Registration Number
- NCT00732940
- Lead Sponsor
- Human Genome Sciences Inc.
- Brief Summary
The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 56
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
- Active SLE disease
- On stable SLE treatment regimen
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Belimumab Q2WKS Belimumab 100 mg SC 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. Belimumab 3X/WK Belimumab 100 mg SC 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.
- Primary Outcome Measures
Name Time Method Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. Up to 24 weeks SEE ALSO ADVERSE EVENTS RESULTS SECTION
Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24 Baseline, 24 weeks Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24. Baseline, 24 Weeks Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24 Baseline, 24 weeks Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24 Baseline, 24 weeks Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 Baseline, 24 Weeks Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 Baseline, 24 Weeks Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 Baseline, 24 Weeks Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 Baseline, 24 Weeks
- Secondary Outcome Measures
Name Time Method Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks. Baseline, 24 weeks Absolute Change From Baseline in IgA at Week 24 Baseline, 24 Weeks Median Percent Change From Baseline in IgA at Week 24 Baseline, 24 weeks Absolute Change From Baseline in IgG at Week 24 Baseline, 24 Weeks Median Percent Change From Baseline in IgG at Week 24 Baseline, 24 Weeks Absolute Change From Baseline in IgM at Week 24 Baseline, 24 Weeks Median Percent Change From Baseline in IgM at Week 24 Baseline, 24 weeks Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24 Baseline, 24 Weeks 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. Baseline, 24 weeks 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 Baseline, 24 Weeks 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 Baseline, 24 weeks Absolute Change From Baseline in Complement C3 at Week 24 Baseline, 24 Weeks Median Percent Change From Baseline in Compliment C3 at Week 24 Baseline, 24 Weeks Absolute Change From Baseline in Complement C4 at Week 24 Baseline, 24 weeks Median Percent Change From Baseline in Complement C4 at Week 24 Baseline, 24 Weeks Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24 Baseline, 24 Weeks Median Percent Change From Baseline in Anti-dsDNA at Week 24 Baseline, 24 weeks Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24 Baseline, 24 Weeks Median Percent Change From Baseline in HDL at Week 24 Baseline, 24 week Absolute Change From Baseline in Total Cholesterol at Week 24 Baseline, 24 Weeks Median Percent Change From Baseline in Total Cholesterol at Week 24 Baseline, 24 Weeks Median Percent Change From Baseline in Triglycerides at Week 24 Baseline, 24 weeks Absolute Change From Baseline in Triglycerides at Week 24 Baseline, 24 Weeks
Trial Locations
- Locations (11)
STAT Research, Inc.
🇺🇸Dayton, Ohio, United States
Valerious Medical Group Research Center
🇺🇸Long Beach, California, United States
Hospital Central "Igancio Morones Prieto"
🇲🇽San Lusi Potosi, Mexico
Fiechtner Research, Inc.
🇺🇸Lansing, Michigan, United States
North Shore-LIJ Health System/Rheumatology, Allergy, Immunology
🇺🇸Lake Success, New York, United States
Oklahoma Center for Arthritis Therapy & Research
🇺🇸Tulsa, Oklahoma, United States
Rheumatology Associates
🇺🇸Smithtown, New York, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Tampa Medical Group, PA
🇺🇸Tampa, Florida, United States
Houston Institute for Clinical Research
🇺🇸Houston, Texas, United States