Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00732940
• Date of registration: 08/08/2008
• Prospective Registration: Yes
• Primary sponsor: Human Genome Sciences Inc.
• Public title: Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)
• Scientific 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)
• Date of first enrolment: October 2008
• Target sample size: 56
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00732940
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Mexico, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Belimumab 100 mg SC

Primary Outcome(s)

Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24 [Time Frame: Baseline, 24 weeks]

Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 [Time Frame: Baseline, 24 Weeks]

Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24 [Time Frame: Baseline, 24 weeks]

Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 [Time Frame: Baseline, 24 Weeks]

Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period. [Time Frame: Up to 24 weeks]

Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24 [Time Frame: Baseline, 24 Weeks]

Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24. [Time Frame: Baseline, 24 Weeks]

Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24 [Time Frame: Baseline, 24 weeks]

Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24 [Time Frame: Baseline, 24 Weeks]

Secondary Outcome(s)

Mean Percent Change From Baseline in PGA Score at Week 24. [Time Frame: Baseline, 24 weeks]

Median Percent Change From Baseline in Compliment C3 at Week 24 [Time Frame: Baseline, 24 Weeks]

Absolute Change From Baseline in Complement C3 at Week 24 [Time Frame: Baseline, 24 Weeks]

Median Percent Change From Baseline in Total Cholesterol at Week 24 [Time Frame: Baseline, 24 Weeks]

Absolute Change From Baseline in Total Cholesterol at Week 24 [Time Frame: Baseline, 24 Weeks]

Absolute Change From Baseline in Triglycerides at Week 24 [Time Frame: Baseline, 24 Weeks]

Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24 [Time Frame: Baseline, 24 Weeks]

Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24 [Time Frame: 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 [Time Frame: Baseline, 24 Weeks]

Median Percent Change From Baseline in HDL at Week 24 [Time Frame: Baseline, 24 week]

Median Percent Change From Baseline in IgG at Week 24 [Time Frame: Baseline, 24 Weeks]

Absolute Change From Baseline in Complement C4 at Week 24 [Time Frame: Baseline, 24 weeks]

Absolute Change From Baseline in IgM at Week 24 [Time Frame: Baseline, 24 Weeks]

Median Percent Change From Baseline in Triglycerides at Week 24 [Time Frame: Baseline, 24 weeks]

Median Percent Change From Baseline in Anti-dsDNA at Week 24 [Time Frame: Baseline, 24 weeks]

Absolute Change From Baseline in IgA at Week 24 [Time Frame: Baseline, 24 Weeks]

Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24 [Time Frame: Baseline, 24 Weeks]

Median Percent Change From Baseline in IgM at Week 24 [Time Frame: Baseline, 24 weeks]

Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24 [Time Frame: Baseline, 24 weeks]

Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks. [Time Frame: Baseline, 24 weeks]

Median Percent Change From Baseline in IgA at Week 24 [Time Frame: Baseline, 24 weeks]

Absolute Change From Baseline in IgG at Week 24 [Time Frame: Baseline, 24 Weeks]

Median Percent Change From Baseline in Complement C4 at Week 24 [Time Frame: Baseline, 24 Weeks]

Secondary ID(s)

HGS1006-1070

112232

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline

Results

• Results available: Yes
• Date Posted: 05/05/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00732940