Last updated: 11/03/2018 12:43:48
Phase 2 study of Belimumab administered subcutaneously to subjects with Systemic Lupus Erythematosus (SLE)
GSK study ID
112232
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: The purpose of this study is to test the safety and tolerability of repeated subcutaneous (SC) doses of belimumab in subjects with SLE.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.
Timeframe: Up to 24 weeks
Absolute change from baseline in CD20+ (total) B cells at Week 24
Timeframe: Baseline, 24 weeks
Median Percent change from baseline in CD20+ (total) B cells at Week 24.
Timeframe: Baseline, 24 Weeks
Absolute Change From Baseline in CD20+/CD27- (Naive) B cells at Week 24
Timeframe: Baseline, 24 weeks
Median percent change from baseline in CD20+/CD27-(naive) B cells at Week 24
Timeframe: Baseline, 24 weeks
Absolute change from baseline in CD20+/CD69+ (activated) B cells at Week 24
Timeframe: Baseline, 24 Weeks
Median percent change from baseline in CD20+/CD69+ (activated) B cells at Week 24
Timeframe: Baseline, 24 Weeks
Absolute change from baseline in CD20+/CD27+ (memory) B cells at Week 24
Timeframe: Baseline, 24 Weeks
Median percent change from baseline in CD20+/CD27+ (Memory) B cells at Week 24
Timeframe: Baseline, 24 Weeks
Secondary outcomes:
Mean serum belimumab concentration levels (pharmacokinetic [PK]) over 24 Weeks.
Timeframe: Baseline, 24 weeks
Absolute Change From Baseline in IgA at Week 24
Timeframe: Baseline, 24 Weeks
Median Percent change from baseline in IgA at Week 24
Timeframe: Baseline, 24 weeks
Absolute Change From Baseline in IgG at Week 24
Timeframe: Baseline, 24 Weeks
Median Percent Change From Baseline in IgG at Week 24
Timeframe: Baseline, 24 Weeks
Absolute Change From Baseline in IgM at Week 24
Timeframe: Baseline, 24 Weeks
Median Percent Change From Baseline in IgM at Week 24
Timeframe: Baseline, 24 weeks
Absolute change from baseline in Physician's Global Assessment (PGA) Score at Week 24
Timeframe: Baseline, 24 Weeks
Mean Percent change from baseline in PGA score at Week 24.
Timeframe: Baseline, 24 weeks
Absolute Change From Baseline in the Safety of Estrogen in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24
Timeframe: Baseline, 24 Weeks
Mean Percent change from baseline in the SELENA SLEDAI Score at Week 24
Timeframe: Baseline, 24 weeks
Absolute Change From Baseline in Complement C3 at Week 24
Timeframe: Baseline, 24 Weeks
Median Percent change from Baseline in Compliment C3 at Week 24
Timeframe: Baseline, 24 Weeks
Absolute Change From Baseline in Complement C4 at Week 24
Timeframe: Baseline, 24 weeks
Median Percent change from Baseline in Complement C4 at Week 24
Timeframe: Baseline, 24 Weeks
Absolute Change From Baseline in Anti-Double-Stranded DNA (anti-dsDNA)at Week 24
Timeframe: Baseline, 24 Weeks
Median Percent change from baseline in anti-dsDNA at Week 24
Timeframe: Baseline, 24 weeks
Absolute Change From Baseline in high density lipoproteins (HDL) at Week 24
Timeframe: Baseline, 24 Weeks
Median Percent change from baseline in HDL at Week 24
Timeframe: Baseline, 24 week
Absolute Change From Baseline in Total Cholesterol at Week 24
Timeframe: Baseline, 24 Weeks
Median Percent Change From Baseline in total cholesterol at Week 24
Timeframe: Baseline, 24 Weeks
Median Percent Change From Baseline in Triglycerides at Week 24
Timeframe: Baseline, 24 weeks
Absolute Change From Baseline in Triglycerides at Week 24
Timeframe: Baseline, 24 Weeks
Interventions:
Drug: Belimumab 100 mg SC
Enrollment:
56
Observational study model:
Not applicable
Primary completion date:
2009-05-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
GlaxoSmithKline
Study date(s)
October 2008 to January 2012
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
- Active SLE disease
- Pregnant or nursing
- Have received treatment with an B cell targeted therapy
Inclusion and exclusion 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
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2009-05-08
Actual study completion date
2012-30-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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