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
Phase 2
Withdrawn
- Conditions
- Microscopic PolyangiitisGranulomatosis With Polyangiitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT01598857
- Lead Sponsor
- Anthera Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Blisibimod Blisibimod - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Induction of clinical remission 24 weeks Clinical remission includes the ability to taper corticosteroids.
- Secondary Outcome Measures
Name Time Method 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 Time to complete remission Various timepoints to 24 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
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