CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus
This study is currently recruiting participants.
Verified April 2013 by Anthera Pharmaceuticals
Sponsor:
Anthera Pharmaceuticals
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01395745
First received: July 14, 2011
Last updated: April 4, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Lupus Erythematosus |
Drug: blisibimod Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus |
Resource links provided by NLM:
Further study details as provided by Anthera Pharmaceuticals:
Primary Outcome Measures:
- Proportion of patients achieving an SLE Responder Index at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to first severe SLE flare [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
- Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
- Change in the number of actively tender or swollen joints and in mucocutaneous disease activity [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Change in proteinuria from baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Proportion of subjects with improved patient-reported outcomes [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Through Week 52 ] [ Designated as safety issue: No ]
- Change from baseline in B cell subsets, anti dsDNA, C3, C4 [ Time Frame: Through Week 52 ] [ Designated as safety issue: No ]
- Safety profile (AEs, vital signs, labs, physical exams) [ Time Frame: Through Week 52 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: blisibimod weekly dose |
Drug: blisibimod
blisibimod administered via subcutaneous injection every week for 52 weeks
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo will be administered weekly via subcutaneous injection for 52 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology
- Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)
- Active SLE disease as defined by the appropriate SELENA-SLEDAI score
- On stable SLE treatment including corticosteroid
- 18 years of age or older
Exclusion Criteria:
- Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension or poorly controlled diabetes
- Malignancy within past 5 years
- Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
- Liver disease
- Anemia, neutropenia, or thrombocytopenia
- Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
- History of active tuberculosis or a history of tuberculosis infection
- Pregnant or nursing
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395745
Contacts
| Contact: Monica Gangal | 510-856-5600 ext 5574 | mgangal@anthera.com |
Locations
| Georgia | |
| Investigator Site 001 | Recruiting |
| Tbilisi, Georgia, 0102 | |
| Investigator Site 002 | Recruiting |
| Tbilisi, Georgia, 0186 | |
| Investigator Site 003 | Recruiting |
| Tbilisi, Georgia, 0186 | |
Sponsors and Collaborators
Anthera Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Anthera Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01395745 History of Changes |
| Other Study ID Numbers: | AN-SLE3331 |
| Study First Received: | July 14, 2011 |
| Last Updated: | April 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Anthera Pharmaceuticals:
|
SLE Lupus Lupus Erythematosus, Systemic |
Autoimmune Diseases A-623 Blisibimod |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013