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
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2009-05-08
    Observational study model:
    Not applicable
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    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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