CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score ≥10.
Trial Health
Trial Health Score
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Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2014
CompletedFirst Posted
Study publicly available on registry
February 28, 2014
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedAugust 13, 2015
August 1, 2015
2.5 years
February 26, 2014
August 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of responders to the SRI-8 composite responder index
52 Weeks
Secondary Outcomes (8)
Time to first severe SLE flare
Baseline through 52 weeks
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
52 Weeks
Change in proteinuria from baseline
Week 52
Proportion of subjects able to reduce oral steroid dose
Baseline through 52 weeks
Proportion of subjects with improved patient-reported outcomes
Week 52
- +3 more secondary outcomes
Other Outcomes (1)
Subgroup analyses of blisibimod effect in subjects with renal manifestations at baseline
52 Weeks
Study Arms (2)
Blisibimod
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- Subjects with stable nephritis may be enrolled
- years of age or older
You may not qualify if:
- Severe active vasculitis, active central nervous system lupus, 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PMID: 33687069DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2014
First Posted
February 28, 2014
Study Start
December 1, 2015
Primary Completion
June 1, 2018
Last Updated
August 13, 2015
Record last verified: 2015-08