CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: blisibimod
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blisibimod weekly dose<br> | Drug: blisibimod<br>* blisibimod administered via subcutaneous injection every week for 52 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo will be administered weekly via subcutaneous injection for 52 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving an SLE Responder Index at week 52 |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first severe SLE flare |  | Week 52 | 
| Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone |  | Week 52 | 
| Change in the number of actively tender or swollen joints and in mucocutaneous disease activity |  | Week 52 | 
| Change in proteinuria from baseline |  | Week 52 | 
| Proportion of subjects with improved patient-reported outcomes |  | Week 52 | 
| Time to treatment failure |  | Week 52 | 
| Time to first renal flare |  | Week 52 | 
| Change from baseline in B cell subsets, anti dsDNA, C3, C4 |  | Week 52 | 
| Safety Profile (AEs, vital signs, labs, physical exams) |  | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod