Trial record 1 of 1 for:
NCT01395745
CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus (CHABLIS-SC1)
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| ClinicalTrials.gov Identifier: NCT01395745 |
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Recruitment Status :
Completed
First Posted : July 18, 2011
Last Update Posted : February 3, 2017
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Sponsor:
Anthera Pharmaceuticals
Information provided by (Responsible Party):
Anthera Pharmaceuticals
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Brief Summary:
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 as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Systemic Lupus Erythematosus | Drug: blisibimod Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 442 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | February 2013 |
| Actual Primary Completion Date : | July 2016 |
| Actual Study Completion Date : | October 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Systemic lupus erythematosus
MedlinePlus related topics:
Lupus
| Arm | Intervention/treatment |
|---|---|
| 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 |
Primary Outcome Measures :
- Proportion of patients achieving an SLE Responder Index at week 52 [ Time Frame: Week 52 ]
Secondary Outcome Measures :
- Time to first severe SLE flare [ Time Frame: Week 52 ]
- Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone [ Time Frame: Week 52 ]
- Change in the number of actively tender or swollen joints and in mucocutaneous disease activity [ Time Frame: Week 52 ]
- Change in proteinuria from baseline [ Time Frame: Week 52 ]
- Proportion of subjects with improved patient-reported outcomes [ Time Frame: Week 52 ]
- Time to treatment failure [ Time Frame: Week 52 ]
- Time to first renal flare [ Time Frame: Week 52 ]
- Change from baseline in B cell subsets, anti dsDNA, C3, C4 [ Time Frame: Week 52 ]
- Safety Profile (AEs, vital signs, labs, physical exams) [ Time Frame: Week 52 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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 SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395745
Locations
Show 90 study locations
Sponsors and Collaborators
Anthera Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anthera Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01395745 |
| Other Study ID Numbers: |
AN-SLE3331 |
| First Posted: | July 18, 2011 Key Record Dates |
| Last Update Posted: | February 3, 2017 |
| Last Verified: | August 2016 |
Keywords provided by Anthera Pharmaceuticals:
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SLE Lupus Lupus Erythematosus, Systemic |
Autoimmune Diseases A-623 Blisibimod |
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |