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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01598857

Acronym

BIANCA-SC

Enrollment

Registered

2012-05-15

Start date

2014-12-31

Completion date

Unknown

Last updated

2015-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Granulomatosis With Polyangiitis, Microscopic Polyangiitis

Keywords

granulomatosis with polyangiitis, microscopic polyangiitis, anti-neutrophil cytoplasmic antibodies, ANCA-associated vasculitis, Wegener Granulomatosis

Brief summary

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.

Interventions

DRUGBlisibimod

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 18 years of age or older (male or female). 2. 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. 3. Active GPA or MPA disease at screening. 4. Positive for either PR3-ANCA or MPO-ANCA at screening. 5. Subject willing to initiate corticosteroids and methotrexate (MTX) if not already on corticosteroids and/or MTX at baseline. 6. Clinical intention to prescribe MTX therapy for treatment of GPA or MPA.

Exclusion criteria

1. Diagnosed with Churg Strauss syndrome. 2. Severe GPA or MPA disease that would conventionally be treated with cyclophosphamide. 3. Nursing or pregnant. 4. Active systemic infection or deep-space infection. 5. Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C. 6. Liver disease. 7. History of documented anti-glomerular basement membrane (GBM) disease. 8. Malignancy within the past 5 years. 9. History of active tuberculosis (TB) or history of TB infection. 10. Anemia, neutropenia, or thrombocytopenia. 11. Serum creatinine level greater than 2.5 mg/dL. 12. Prior administration of a B-cell modulating therapy other than rituximab. 13. Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study. 14. History of congenital immunodeficiency.

Design outcomes

Primary

Measure	Time frame	Description
Induction of clinical remission	24 weeks	Clinical remission includes the ability to taper corticosteroids.

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026