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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2015
• Main ID: NCT01598857
• Date of registration: 11/05/2012
• Prospective Registration: Yes
• Primary sponsor: Anthera Pharmaceuticals
• Public title: 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
• Scientific 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
• Date of first enrolment: December 2014
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01598857
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Granulomatosis With Polyangiitis

Microscopic Polyangiitis

Intervention(s)

Drug: Blisibimod

Drug: Placebo

Primary Outcome(s)

Induction of clinical remission [Time Frame: 24 weeks]

Secondary Outcome(s)

Safety profile [Time Frame: Various timepoints to 24 weeks]

Time to treatment failure [Time Frame: Various timepoints to 24 weeks]

Ability to taper corticosteroids [Time Frame: Various timepoints to 24 weeks]

Compare biomarker changes from baseline [Time Frame: Various timepoints to 24 weeks]

Change in baseline BVAS/WG score [Time Frame: Various timepoints to 24 weeks]

Time to complete remission [Time Frame: Various timepoints to 24 weeks]

Secondary ID(s)

AN-VAS3321

Source(s) of Monetary Support

Please refer to primary and secondary sponsors