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

Microscopic Polyangiitis Clinical Trial

— BIANCA-SC  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01598857
• Other study ID #: AN-VAS3321
• Status: Withdrawn
• Phase: Phase 2
• First received: May 11, 2012
• Last updated: July 28, 2015
• Start date: December 2014

Study information

• Verified date: July 2015
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Granulomatosis With Polyangiitis
• Microscopic Polyangiitis
• Systemic Vasculitis
• Vasculitis
• Wegener Granulomatosis

Intervention

Drug:
• Blisibimod

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction of clinical remission	Clinical remission includes the ability to taper corticosteroids.	24 weeks	No
Secondary	Time to complete remission		Various timepoints to 24 weeks	No
Secondary	Time to treatment failure		Various timepoints to 24 weeks	No
Secondary	Ability to taper corticosteroids		Various timepoints to 24 weeks	No
Secondary	Change in baseline BVAS/WG score		Various timepoints to 24 weeks	No
Secondary	Safety profile		Various timepoints to 24 weeks	Yes
Secondary	Compare biomarker changes from baseline		Various timepoints to 24 weeks	No