BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when taken with methotrexate in the induction of remission in ANCA-Associated Small Vessel Vasculitis.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis

Conditions
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Granulomatosis With Polyangiitis, Microscopic Polyangiitis

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 (male or female). Granulomatosis with polyangiitis (GPA, or Wegener's granulomatosis) or microscopic polyangiitis (MPA) according to the definitions of the American College of Rheumatology and Chapel Hill Consensus Conference. Active GPA or MPA disease at screening. Positive for either PR3-ANCA or MPO-ANCA at screening. Subject willing to initiate corticosteroids and methotrexate (MTX) if not already on corticosteroids and/or MTX at baseline. Clinical intention to prescribe MTX therapy for treatment of GPA or MPA. Exclusion Criteria: Diagnosed with Churg Strauss syndrome. Severe GPA or MPA disease that would conventionally be treated with cyclophosphamide. Nursing or pregnant. Active systemic infection or deep-space infection. Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C. Liver disease. History of documented anti-glomerular basement membrane (GBM) disease. Malignancy within the past 5 years. History of active tuberculosis (TB) or history of TB infection. Anemia, neutropenia, or thrombocytopenia. Serum creatinine level greater than 2.5 mg/dL. Prior administration of a B-cell modulating therapy other than rituximab. Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study. History of congenital immunodeficiency.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blisibimod<br> | Drug: Blisibimod<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction of clinical remission | Clinical remission includes the ability to taper corticosteroids. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete remission |  | Various timepoints to 24 weeks | 
| Time to treatment failure |  | Various timepoints to 24 weeks | 
| Ability to taper corticosteroids |  | Various timepoints to 24 weeks | 
| Change in baseline BVAS/WG score |  | Various timepoints to 24 weeks | 
| Safety profile |  | Various timepoints to 24 weeks | 
| Compare biomarker changes from baseline |  | Various timepoints to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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granulomatosis with polyangiitis, microscopic polyangiitis, anti-neutrophil cytoplasmic antibodies, ANCA-associated vasculitis, Wegener Granulomatosis