CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Syste… (NCT02074020) | Clinical Trial Compass
WithdrawnPhase 3
CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
0Started 2015-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
* Subjects with stable nephritis may be enrolled
* 18 years of age or older
Exclusion Criteria:
* 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
What they're measuring
1
Proportion of responders to the SRI-8 composite responder index