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Original TRDS for trail "A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus " created on Dec 04, 2015


SLCTR Registration Number

SLCTR/2015/002

Date of Registration

20 Jan 2015

The date of last modification

Dec 04, 2015

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Trial Status


Application Summary

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


Trial Details

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

  1. Study centres in Sri Lanka: • National Hospital, Colombo • Sri Jayawardenapura General Hospital • Teaching Hospital Kandy

  2. 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

  1. Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology (in addition to criteria 2 and 3 below)

  2. Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)

  3. Active SLE disease as defined by SELENA-SLEDAI score >10 despite on-going stable corticosteroid therapy

  4. 18 years of age or older

Exclusion criteria

  1. Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension or poorly controlled diabetes
  2. Malignancy within past 5 years
  3. Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
  4. Liver disease
  5. Anemia, neutropenia, or thrombocytopenia
  6. Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
  7. History of active tuberculosis or a history of tuberculosis infection
  8. Pregnant or nursing

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]

 [

Week 52

]

Secondary outcome(s)

1.
  1. Time to first severe SLE flare
  2. Proportion of subjects able to reduce oral steroid dose to >7.5 mg/day prednisone
  3. Change in the number of actively tender or swollen joints and in mucocutaneous disease
  4. Change in proteinuria from baseline
  5. Proportion of subjects with improved patient-reported outcomes
  6. Time to treatment
  7. Time to first renal flare
  8. Change from baseline in B cell subsets, anti dsDNA, C3, C4
  9. Safety Profile (AEs, vital signs, labs, physical exams)
 [

From baseline to week 52

]
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

Argentina, 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

Date of study completion

Recruitment status

Recruiting

Funding source

Anthera Pharmaceuticals Inc

Regulatory approvals


State of Ethics Review Approval

Status

Date of Approval

Approval number

Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:

Contact & Sponsor Information

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

Secondary study sponsor (If any)

None





Trial Completion details

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

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results