CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

Study Overview
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Brief Summary
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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.

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 With or Without Nephritis

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 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

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<br> | Drug: Blisibimod<br>* Administered via subcutaneous injection once per week<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Administered via subcutaneous injection once per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of responders to the SRI-8 composite responder index |  | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time to treatment failure |  | Through week 52 | 
| Change from baseline in B cell subsets, anti-dsDNA, C3, C4 |  | Through week 52 | 
| Safety profile (AEs, vital signs, labs, physical exams) |  | Through 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, Nephritis