BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration

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 administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy with persistent proteinuria of between 1-6 g/day.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: Blisibimod
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 65 years of age, inclusive Biopsy-proven IgA nephropathy Receiving stable, clinically-optimized ACEI and/or ARB Proteinuria ≥ 1g/24hr but ≤ 6g/24hr at 2 consecutive time points Exclusion Criteria: Clinical or histologic evidence of non-IgA-related glomerulonephritis IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring Meets eGFR criteria History of treatment with oral or parenteral corticosteroids within 3 months or immunosuppressants within 6 months 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 Neutropenia 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
Maximum Age: 65 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>Blisibimod administered subcutaneously | Drug: Blisibimod<br> <br> |
| Placebo Comparator: Placebo<br>Placebo administered subcutaneously | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving reduction in proteinuria from baseline |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum immunoglobulins IgA, IgG and IgM |  | 24 weeks | 
| Percent reduction from baseline in plasma cells and B-cell subsets |  | 24 weeks | 
| Percent change from baseline in complement C3 and C4 |  | 24 weeks | 
| Proportion of subjects progressing to End Stage Renal Disease |  | Approximately 104 weeks | 
| Proportion of subjects achieving reduction in proteinuria from baseline |  | Approximately 104 weeks | 
| Numbers of subjects requiring the addition of corticosteroid or other therapy |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgAN, IgA Nephropathy, A-623, Blisibimod, Kidney Disease, Persistent proteinuria