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
BIANCA-SC
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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedJuly 30, 2015
July 1, 2015
6 months
May 11, 2012
July 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Induction of clinical remission
Clinical remission includes the ability to taper corticosteroids.
24 weeks
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Blisibimod
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2012
First Posted
May 15, 2012
Study Start
December 1, 2014
Primary Completion
June 1, 2015
Last Updated
July 30, 2015
Record last verified: 2015-07