Clinical trial NCT00732940: Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Lupus
Systemic Lupus Erythematosus
Antibodies
Autoimmune Diseases
Belimumab
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-08-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Evaluation of the Number of Participants Who Experienced Adverse Events (AEs) During the 24 Week Period.
timeFrame: Up to 24 weeks
measure: Absolute Change From Baseline in CD20+ (Total) B Cells at Week 24
timeFrame: Baseline, 24 weeks
measure: Median Percent Change From Baseline in CD20+ (Total) B Cells at Week 24.
timeFrame: Baseline, 24 Weeks
measure: Absolute Change From Baseline in CD20+/CD27- (Naive) B Cells at Week 24
timeFrame: Baseline, 24 weeks
measure: Median Percent Change From Baseline in CD20+/CD27-(Naive) B Cells at Week 24
timeFrame: Baseline, 24 weeks
measure: Absolute Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
timeFrame: Baseline, 24 Weeks
measure: Median Percent Change From Baseline in CD20+/CD69+ (Activated) B Cells at Week 24
timeFrame: Baseline, 24 Weeks
measure: Absolute Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
timeFrame: Baseline, 24 Weeks
measure: Median Percent Change From Baseline in CD20+/CD27+ (Memory) B Cells at Week 24
timeFrame: Baseline, 24 Weeks
Secondary outcomes:
measure: Mean Serum Belimumab Concentration Levels (Pharmacokinetic [PK]) Over 24 Weeks.
timeFrame: Baseline, 24 weeks
measure: Absolute Change From Baseline in IgA at Week 24
timeFrame: Baseline, 24 Weeks
measure: Median Percent Change From Baseline in IgA at Week 24
timeFrame: Baseline, 24 weeks
measure: Absolute Change From Baseline in IgG at Week 24
timeFrame: Baseline, 24 Weeks
measure: Median Percent Change From Baseline in IgG at Week 24
timeFrame: Baseline, 24 Weeks
measure: Absolute Change From Baseline in IgM at Week 24
timeFrame: Baseline, 24 Weeks
measure: Median Percent Change From Baseline in IgM at Week 24
timeFrame: Baseline, 24 weeks
measure: Absolute Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24
timeFrame: Baseline, 24 Weeks
measure: Mean Percent Change From Baseline in PGA Score at Week 24.
timeFrame: Baseline, 24 weeks
measure: 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
measure: Mean Percent Change From Baseline in the SELENA SLEDAI Score at Week 24
timeFrame: Baseline, 24 weeks
measure: Absolute Change From Baseline in Complement C3 at Week 24
timeFrame: Baseline, 24 Weeks
measure: Median Percent Change From Baseline in Compliment C3 at Week 24
timeFrame: Baseline, 24 Weeks
measure: Absolute Change From Baseline in Complement C4 at Week 24
timeFrame: Baseline, 24 weeks
measure: Median Percent Change From Baseline in Complement C4 at Week 24
timeFrame: Baseline, 24 Weeks
measure: Absolute Change From Baseline in Anti-Double-Stranded DNA (Anti-dsDNA)at Week 24
timeFrame: Baseline, 24 Weeks
measure: Median Percent Change From Baseline in Anti-dsDNA at Week 24
timeFrame: Baseline, 24 weeks
measure: Absolute Change From Baseline in High Density Lipoproteins (HDL) at Week 24
timeFrame: Baseline, 24 Weeks
measure: Median Percent Change From Baseline in HDL at Week 24
timeFrame: Baseline, 24 week
measure: Absolute Change From Baseline in Total Cholesterol at Week 24
timeFrame: Baseline, 24 Weeks
measure: Median Percent Change From Baseline in Total Cholesterol at Week 24
timeFrame: Baseline, 24 Weeks
measure: Median Percent Change From Baseline in Triglycerides at Week 24
timeFrame: Baseline, 24 weeks
measure: Absolute Change From Baseline in Triglycerides at Week 24
timeFrame: Baseline, 24 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Long Beach
country: United States
facility: Valerious Medical Group Research Center
state: California
city: Tampa
country: United States
facility: Tampa Medical Group, PA
state: Florida
city: Lansing
country: United States
facility: Fiechtner Research, Inc.
state: Michigan
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Lake Success
country: United States
facility: North Shore-LIJ Health System/Rheumatology, Allergy, Immunology
state: New York
city: Smithtown
country: United States
facility: Rheumatology Associates
state: New York
city: Dayton
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Center for Arthritis Therapy & Research
state: Oklahoma
city: Houston
country: United States
facility: Houston Institute for Clinical Research
state: Texas
city: San Lusi Potosi
country: Mexico
facility: Hospital Central "Igancio Morones Prieto"
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.