Immune Thrombocytopenic PurpuraPhase 2/3NCT01609452
MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITP
A Phase 2/3 study testing Blisibimod in people with Immune Thrombocytopenic Purpura and Idiopathic Thrombocytopenic Purpura, run by Anthera Pharmaceuticals.
Trial summary
The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when administered on top of standard-of-care to subjects with Immune Thrombocytopenic Purpura (ITP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura
- 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 2015to Jun 2016
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years of age(male or female).
- Diagnosis of ITP according to the guidelines of the American Society of Hematology (ASH) and British Committee for Standards in Hematology.
- Platelet counts at Screening of 30 billion/L or less for subjects not on ITP medication, or 50 billion/L or less for subjects receiving stable background ITP medication.
Who cannot join
- Subjects who have had a splenectomy for any reason.
- Currently receiving high-dose ITP medications, eltrombopag, romiplostim, rituximab, or investigational therapeutic agents.
- Nursing or pregnant.
- Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days.
- Any known history of bone marrow stem cell disorder.
- Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
Show all 11Show fewer
- Liver disease.
- Malignancy within the past 5 years.
- History of active tuberculosis (TB) or history of TB infection.
- 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: MONICA-SC: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With Immune Thrombocytopenic Purpura (ITP)
The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when administered on top of standard-of-care to subjects with Immune Thrombocytopenic Purpura (ITP).
- Being tested
- Blisibimod, Placebo
- Keywords
- Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Chronic ITP
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlisibimodBiological
Also called A-623
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Blisibimod | Experimental | Not described Receives: Biological: Blisibimod |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment.
Measured: 24 weeks
Secondary outcomes (8)
Achievement of a durable platelet count of 50 billion platelets per liter or higher over the last weeks of treatment under conditions of decreased concomitant steroid medication.
Measured: 24 weeks
Achievement of a transient improvement in platelet count of 50 billion platelets per liter or higher at any 4 weeks of the treatment period.
Measured: 24 weeks
Change in background corticosteroid dose.
Measured: baseline to 24 weeks
Percentage of subjects requiring rescue therapy.
Measured: 24 weeks
Time to treatment failure.
Measured: 24 weeks
Change in bleeding risk.
Measured: baseline to 24 weeks
Safety profile (AEs, vitals signs, labs)
Measured: 24 weeks
Biomarker changes from baseline.
Measured: baseline 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 posted1 Jun 2012 (estimated)
- Study startDec 2015
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic PurpuraStudies 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 2/3
- 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
- NCT01609452
- Sponsor's protocol ID
- AN-ITP3321
- Status last verified
- Jul 2015
- First submitted
- 23 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
- MONICA-SC: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With Immune Thrombocytopenic Purpura (ITP)
- ClinicalTrials.gov ID
- NCT01609452
- Acronym / sponsor ID
- AN-ITP3321
- Keywords
- Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Chronic ITP
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (estimated)
- First posted
- 1 Jun 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 administered on top of standard-of-care to subjects with Immune Thrombocytopenic Purpura (ITP).
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 | Biological: Blisibimod |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 75 years of age(male or female).
- Diagnosis of ITP according to the guidelines of the American Society of Hematology (ASH) and British Committee for Standards in Hematology.
- Platelet counts at Screening of 30 billion/L or less for subjects not on ITP medication, or 50 billion/L or less for subjects receiving stable background ITP medication.
Key exclusion criteria (11 listed)
- Subjects who have had a splenectomy for any reason.
- Currently receiving high-dose ITP medications, eltrombopag, romiplostim, rituximab, or investigational therapeutic agents.
- Nursing or pregnant.
- Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days.
- Any known history of bone marrow stem cell disorder.
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 |
|---|---|---|
| BlisibimodAlso: A-623 | Biological | Blisibimod |
| Placebo | Other | Placebo |
Primary outcome
Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment.
Time frame: 24 weeks
8 secondary outcomes
Achievement of a durable platelet count of 50 billion platelets per liter or higher over the last weeks of treatment under conditions of decreased concomitant steroid medication.
Time frame: 24 weeks
Achievement of a transient improvement in platelet count of 50 billion platelets per liter or higher at any 4 weeks of the treatment period.
Time frame: 24 weeks
Change in background corticosteroid dose.
Time frame: baseline to 24 weeks
Percentage of subjects requiring rescue therapy.
Time frame: 24 weeks
Time to treatment failure.
Time frame: 24 weeks
Change in bleeding risk.
Time frame: baseline to 24 weeks
Safety profile (AEs, vitals signs, labs)
Time frame: 24 weeks
Biomarker changes from baseline.
Time frame: baseline 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 2/3 study testing Blisibimod in people with Immune Thrombocytopenic Purpura and Idiopathic Thrombocytopenic Purpura, 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 3 inclusion and 11 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment. (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.