Granulomatosis With PolyangiitisPhase 2BIANCA-SCNCT01598857
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
A Phase 2 study testing Blisibimod in people with Granulomatosis With Polyangiitis and Microscopic Polyangiitis, run by Anthera Pharmaceuticals.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Granulomatosis With Polyangiitis, Microscopic Polyangiitis
- What is being tested?
- Blisibimod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
- Being tested
- Blisibimod, Placebo
- Keywords
- granulomatosis with polyangiitis, microscopic polyangiitis, anti-neutrophil cytoplasmic antibodies, ANCA-associated vasculitis, Wegener Granulomatosis
- Medical subject headings
- Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlisibimodDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Blisibimod | Experimental | Not described Receives: Drug: Blisibimod |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction of clinical remission
Clinical remission includes the ability to taper corticosteroids.
Measured: 24 weeks
Secondary outcomes (6)
Time to complete remission
Measured: Various timepoints to 24 weeks
Time to treatment failure
Measured: Various timepoints to 24 weeks
Ability to taper corticosteroids
Measured: Various timepoints to 24 weeks
Change in baseline BVAS/WG score
Measured: Various timepoints to 24 weeks
Safety profile
Measured: Various timepoints to 24 weeks
Compare biomarker changes from baseline
Measured: Various timepoints to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startDec 2014
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulomatosis With PolyangiitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598857
- Sponsor's protocol ID
- AN-VAS3321
- Acronym
- BIANCA-SC
- Status last verified
- Jul 2015
- First submitted
- 11 May 2012
- Last updated
- 30 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01598857
- Acronym / sponsor ID
- BIANCA-SC / AN-VAS3321
- Keywords
- granulomatosis with polyangiitis, microscopic polyangiitis, anti-neutrophil cytoplasmic antibodies, ANCA-associated vasculitis, Wegener Granulomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jun 2015 (estimated)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blisibimod | Experimental | Drug: Blisibimod |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blisibimod | Drug | Blisibimod |
| Placebo | Drug | Placebo |
Primary outcome
Induction of clinical remission
Time frame: 24 weeks
Clinical remission includes the ability to taper corticosteroids.
6 secondary outcomes
Time to complete remission
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
Change in baseline BVAS/WG score
Time frame: Various timepoints to 24 weeks
Safety profile
Time frame: Various timepoints to 24 weeks
Compare biomarker changes from baseline
Time frame: Various timepoints to 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blisibimod in people with Granulomatosis With Polyangiitis and Microscopic Polyangiitis, run by Anthera Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction of clinical remission (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.