Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000327482
Ethics application status
Approved
Date submitted
12/06/2007
Date registered
19/06/2007
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study of Belimumab, a Fully Human Monoclonal Anit-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
Scientific title
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)
Secondary ID [1] 374 0
ClinicalTrials.gov: NCT00424476
Universal Trial Number (UTN)
Trial acronym
BLISS-52
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus (SLE) 1876 0
Condition category
Condition code
Inflammatory and Immune System 1970 1970 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy and safety of belimumab in subjects with active SLE. In addition to stable standard therapy, subjects will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio: 1 mg/kg belimumab, 10 mg/kg belimumab or placebo. At randomization, subjects will be stratified by their screening SELENA SLEDAI score (6-9 vs >= 10), screening proteinuria level (< 2 g/24 hour vs >= 2 g/24 hour equivalent) and race (African descent or indigenous-American descent vs other). Subjects will be dosed with study agent on Days 0, 14, and 28, then every 28 days through 48 weeks, with a final evaluation at Week 52 (4 weeks after the last dose). Study agent will be administered intravenously over 1 hour. Approximately 810 SLE subjects will be randomized at approximately 150 sites, with a target of about 270 subjects per treatment group.

All subjects will continue the stable standard therapy they were receiving during the screening period. All subjects, including withdrawals, will return for an Exit (final evaluation) visit approximately 4 weeks after their last dose of study agent. Subjects who withdraw or do not enter the continuation protocol after 48 weeks of treatment will be required to return for an additional follow-up visit approximately 8 weeks after their last dose of study agent.
Intervention code [1] 1822 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 2785 0
>= 4 point reduction from baseline in SELENA SLEDAI score
Timepoint [1] 2785 0
At week 52 of treatment period
Primary outcome [2] 2786 0
No worsening (increase of < 0.30 points from baseline) in Physician’s Global Assessment (PGA)
Timepoint [2] 2786 0
At week 52 of treatment period
Primary outcome [3] 2787 0
No new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline
Timepoint [3] 2787 0
At week 52 of treatment period
Secondary outcome [1] 4703 0
Percent of subjects with >= 4 point reduction from baseline in SELENA SLEDAI score
Timepoint [1] 4703 0
At week 52 of treatment period
Secondary outcome [2] 4704 0
Mean change in PGA.
Timepoint [2] 4704 0
At week 24 of treatment period
Secondary outcome [3] 4705 0
Mean change in SF-36 Health Survey physical component summary score (PCS)
Timepoint [3] 4705 0
At week 24 of treatment period
Secondary outcome [4] 4706 0
Percent of subjects whose average prednisone dose has been reduced by >= 25% from baseline to =< 7.5 mg/day
Timepoint [4] 4706 0
Weeks 40 through to 52 of treatment period

Eligibility
Key inclusion criteria
Clinical diagnosis of SLE by ACR criteria,

Active SLE disease,

On stable SLE treatment regimen
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or nursing,

Have received treatment with any B cell targeted therapy,

Have received treatment with a biological investigational agent in the past year,

Have received 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 within the past 60 days,

Have current drug or alcohol abuse or dependence,

Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by a interactive voice response system (IVRS)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation by their screening SELENA SLEDAI score (6-9 vs >= 10), screening proteinuria level (< 2 g/24 hour vs >= 2 g/24 hour equivalent) and race (African descent or indigenous-American descent vs other).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The persons blinded in the study include: the subjects, the people administering the treatment/s, the people assessing the outcomes (assessor) and the
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
810
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2110 0
Commercial sector/Industry
Name [1] 2110 0
Human Genome Sciences Inc (HGS)
Country [1] 2110 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Kendle R&D Pty Limited
Address
156-158 Drummond Street
Oakleigh, Victoria, 3166
Country
Australia
Secondary sponsor category [1] 1919 0
Commercial sector/Industry
Name [1] 1919 0
Human Genome Sciences Inc
Address [1] 1919 0
14200 Shady Grove Road
Rockville, Maryland 20850
Country [1] 1919 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3900 0
Royal Perth Hospital Perth
Ethics committee address [1] 3900 0
Ethics committee country [1] 3900 0
Australia
Date submitted for ethics approval [1] 3900 0
Approval date [1] 3900 0
14/05/2007
Ethics approval number [1] 3900 0
EC 2007/097
Ethics committee name [2] 3901 0
Repatriation General Hospital Adelaide
Ethics committee address [2] 3901 0
Ethics committee country [2] 3901 0
Australia
Date submitted for ethics approval [2] 3901 0
Approval date [2] 3901 0
14/05/2007
Ethics approval number [2] 3901 0
17/07
Ethics committee name [3] 3902 0
Emeritus Research Cabrini Hospital Melbourne
Ethics committee address [3] 3902 0
Ethics committee country [3] 3902 0
Australia
Date submitted for ethics approval [3] 3902 0
Approval date [3] 3902 0
15/05/2007
Ethics approval number [3] 3902 0
07-16-04-07
Ethics committee name [4] 4483 0
Southern Health
Ethics committee address [4] 4483 0
Ethics committee country [4] 4483 0
Australia
Date submitted for ethics approval [4] 4483 0
Approval date [4] 4483 0
18/07/2007
Ethics approval number [4] 4483 0
07063A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27636 0
Address 27636 0
Country 27636 0
Phone 27636 0
Fax 27636 0
Email 27636 0
Contact person for public queries
Name 11011 0
Carolyn Trower PhD
Address 11011 0
Kendle R&D Pty Limited
156-158 Drummond St
Oakleigh VIC
3166
Country 11011 0
Australia
Phone 11011 0
+61 3 9567 7616
Fax 11011 0
+61 3 9567 7699
Email 11011 0
trower.carolyn@kendle.com
Contact person for scientific queries
Name 1939 0
Jolanta Airey MD
Address 1939 0
Kendle R&D Pty Limited
156-158 Drummond St
Oakleigh VIC
3166
Country 1939 0
Australia
Phone 1939 0
+61 3 9567 7615
Fax 1939 0
+61 3 9567 7699
Email 1939 0
airey.jolanta@kendle.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.