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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01598857
Recruitment Status : Withdrawn
First Posted : May 15, 2012
Last Update Posted : July 30, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Granulomatosis With Polyangiitis Microscopic Polyangiitis Drug: Blisibimod Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2014
Estimated Primary Completion Date : June 2015

Arm Intervention/treatment
Experimental: Blisibimod Drug: Blisibimod
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Induction of clinical remission [ Time Frame: 24 weeks ]
    Clinical remission includes the ability to taper corticosteroids.

Secondary Outcome Measures :
  1. Time to complete remission [ Time Frame: Various timepoints to 24 weeks ]
  2. Time to treatment failure [ Time Frame: Various timepoints to 24 weeks ]
  3. Ability to taper corticosteroids [ Time Frame: Various timepoints to 24 weeks ]
  4. Change in baseline BVAS/WG score [ Time Frame: Various timepoints to 24 weeks ]
  5. Safety profile [ Time Frame: Various timepoints to 24 weeks ]
  6. Compare biomarker changes from baseline [ Time Frame: Various timepoints to 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Responsible Party: Anthera Pharmaceuticals Identifier: NCT01598857    
Other Study ID Numbers: AN-VAS3321
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015
Keywords provided by Anthera Pharmaceuticals:
granulomatosis with polyangiitis
microscopic polyangiitis
anti-neutrophil cytoplasmic antibodies
ANCA-associated vasculitis
Wegener Granulomatosis
Additional relevant MeSH terms:
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Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Systemic Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases