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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Anthera Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01598857
First received: May 11, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Granulomatosis With Polyangiitis
Microscopic Polyangiitis
Drug: Blisibimod
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • Induction of clinical remission [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Clinical remission includes the ability to taper corticosteroids.


Secondary Outcome Measures:
  • Time to complete remission [ Time Frame: Various timepoints to 24 weeks ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: Various timepoints to 24 weeks ] [ Designated as safety issue: No ]
  • Ability to taper corticosteroids [ Time Frame: Various timepoints to 24 weeks ] [ Designated as safety issue: No ]
  • Change in baseline BVAS/WG score [ Time Frame: Various timepoints to 24 weeks ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: Various timepoints to 24 weeks ] [ Designated as safety issue: Yes ]
  • Compare biomarker changes from baseline [ Time Frame: Various timepoints to 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2014
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blisibimod Drug: Blisibimod
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598857

Contacts
Contact: Colin Hislop chislop@anthera.com

Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

No publications provided

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01598857     History of Changes
Other Study ID Numbers: AN-VAS3321
Study First Received: May 11, 2012
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Anthera Pharmaceuticals:
granulomatosis with polyangiitis
microscopic polyangiitis
anti-neutrophil cytoplasmic antibodies
ANCA-associated vasculitis
Wegener Granulomatosis

Additional relevant MeSH terms:
Systemic Vasculitis
Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Microscopic Polyangiitis
Wegener Granulomatosis
Autoimmune Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Immune System Diseases
Lung Diseases
Lung Diseases, Interstitial
Nervous System Diseases
Respiratory Tract Diseases
Vascular Diseases
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 23, 2014