BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of blisibimod plus standard of care versus placebo plus standard of care alone on the proportion of subjects achieving improvement in renal disease parameters.

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 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 years of age or older. Biopsy-proven IgA nephropathy Proteinuria ≥ 2g/24hr or equivalent Receiving physician-directed optimized standard of care that includes ACEI and/or ARB. Estimated glomerular filtration rate (eGFR) >40mL/min/1.73m2 Exclusion Criteria: Clinical or histologic evidence of non-IgA-related glomerulonephritis IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring Meets eGFR criteria 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

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>* Blisibimod administered subcutaneously<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo administered subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects to achieve the proteinuria threshold |  | Week 24 | 
| The proportion of subjects who progress to end-stage renal disease |  | approximately 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets |  | Week 24 | 
| Number of Participants with Adverse Events |  | Week 24 | 
| Change from baseline in serum creatinine |  | Week 24 | 
| Change from baseline in eGFR |  | Week 24 | 
| The proportion of subjects requiring the addition of corticosteroid or other therapy |  | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blisibimod, IgA nephropathy, BAFF, BLyS