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Withdrawn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 Polyangiitis; Granulomatosis With Polyangiitis
• Interventions: Drug: Blisibimod; 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

Study Timeline

• Study First Submitted: 2012-05-11
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Study Start: 2014-12
• Primary Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• 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