Home » Trials » SLCTR/2015/002
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus
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SLCTR Registration Number
SLCTR/2015/002
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus
Public Title of Trial
A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus
Disease or Health Condition(s) Studied
Systemic Lupus Erythematosus
Scientific Acronym
AN-SLE3331
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EUDRACT No. - 2012-004581-17 , Clinicaltrialgov identifier NCT01395745
What is the research question being addressed?
Is administering subcutaneous blisibimod in addition to standard of care therapy in subjects with active Systemic Lupus Erythematosus (SLE) as defined by SELENA-SLEDAI score >10 despite on-going stable corticosteroid therapy safe and effective in reducing disease activity?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Study centres in Sri Lanka: • Sri Jayawardenapura General Hospital
Number of arms: 2
Participants randomized to the intervention arm will received Blisibimod 200mg by subcutaneous injection once a week for 52 weeks.
Participants in the control arm will receive a matching placebo by sby subcutaneous injection once a week for 52 weeks.
All participants will receive standard of care including corticosteroids, immunosuppressive agents and anti-malarials as per physician discretion.
Inclusion criteria
Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology (in addition to criteria 2 and 3 below)
Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)
Active SLE disease as defined by SELENA-SLEDAI score >10 despite on-going stable corticosteroid therapy
18 years of age or older
Exclusion criteria
Primary outcome(s)
|
1.
Proportion of patients achieving an SLE Responder Index [a composite score derived from the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), the British Isles Lupus Assessment Group (BILAG) A and B scores and physicians global assessment] The primary endpoint variable is modified from SRI-8 to SRI-6 |
[ 53 weeks ] |
Secondary outcome(s)
|
1.
Time to first severe SLE flare |
[ 53 weeks ] |
|
2.
Proportion of subjects able to reduce oral steroid dose to >7.5 mg/day prednisone |
[ 53 weeks ] |
|
3.
Change in the number of actively tender or swollen joints and in mucocutaneous disease |
[ 53 weeks ] |
|
4.
Change in proteinuria from baseline |
[ 53 weeks ] |
|
5.
Proportion of subjects with improved patient-reported outcomes |
[ 53 weeks ] |
|
6.
Time to treatment |
[ 53 weeks ] |
|
7.
Time to first renal flare |
[ 53 weeks ] |
|
8.
Change from baseline in B cell subsets, anti dsDNA, C3, C4 |
[ 53 weeks ] |
|
9.
Safety Profile (AEs, vital signs, labs, physical exams) |
[ 53 weeks ] |
Target number/sample size
Approximately 25 patients from Sri Lanka (total recruitment)
Countries of recruitment
Belarus, Brazil, Colombia, Georgia, Guatemala, Hong Kong, Korea, Democratic People's Republic of, Malaysia, Mexico, Philippines, Russian Federation, Singapore, Sri Lanka, Thailand
Anticipated start date
2015-01-30
Anticipated end date
2016-09-30
Date of first enrollment
2015-04-09
Date of study completion
Recruitment status
Suspended
Funding source
Anthera Pharmaceuticals Inc
Regulatory approvals
Approved (8th August 2014)
Status
Approved
Date of Approval
2014-06-11
Approval number
P93/05/2014
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. LalithSirimevanWijayaratne
Consultant Rheumatologist
National Hospital of Sri Lanka
+94112692681
+94777300414
lalithsw@sltnet.lk
Contact Person for Public Queries
Prof. Asita de Silva
Director
Clinical Trials Unit,
Faculty of Medicine, University of Kelaniya
Thalagolla Road, Ragama, Sri Lanka
+94 112665266
asita@remediumone.com
Primary study sponsor/organization
Anthera Pharmaceuticals, Inc
25801 Industrial Boulevard,
Suite B Hayward,
CA 94545 U.S.A.
Tel: (510) 856–5600
Fax: (510) 856–5597
info@anthera.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
