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

Sponsor

Anthera Pharmaceuticals (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01598857

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Dec 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Blisibimod

Drug: Blisibimod

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Induction of clinical remission [24 weeks]
Clinical remission includes the ability to taper corticosteroids.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age or older (male or female).
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.
Active GPA or MPA disease at screening.
Positive for either PR3-ANCA or MPO-ANCA at screening.
Subject willing to initiate corticosteroids and methotrexate (MTX) if not already on corticosteroids and/or MTX at baseline.
Clinical intention to prescribe MTX therapy for treatment of GPA or MPA.

Exclusion Criteria:

Diagnosed with Churg Strauss syndrome.
Severe GPA or MPA disease that would conventionally be treated with cyclophosphamide.
Nursing or pregnant.
Active systemic infection or deep-space infection.
Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
Liver disease.
History of documented anti-glomerular basement membrane (GBM) disease.
Malignancy within the past 5 years.
History of active tuberculosis (TB) or history of TB infection.
Anemia, neutropenia, or thrombocytopenia.
Serum creatinine level greater than 2.5 mg/dL.
Prior administration of a B-cell modulating therapy other than rituximab.
Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study.
History of congenital immunodeficiency.