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MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITP

Phase 2
Withdrawn
Conditions
Immune Thrombocytopenic Purpura
Idiopathic Thrombocytopenic Purpura
Interventions
Biological: Blisibimod
Other: Placebo
Registration Number
NCT01609452
Lead Sponsor
Anthera Pharmaceuticals
Brief 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).

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  1. 18 to 75 years of age(male or female).
  2. Diagnosis of ITP according to the guidelines of the American Society of Hematology (ASH) and British Committee for Standards in Hematology.
  3. 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.
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Exclusion Criteria
  1. Subjects who have had a splenectomy for any reason.
  2. Currently receiving high-dose ITP medications, eltrombopag, romiplostim, rituximab, or investigational therapeutic agents.
  3. Nursing or pregnant.
  4. Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days.
  5. Any known history of bone marrow stem cell disorder.
  6. Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
  7. Liver disease.
  8. Malignancy within the past 5 years.
  9. History of active tuberculosis (TB) or history of TB infection.
  10. Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study.
  11. History of congenital immunodeficiency.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BlisibimodBlisibimod-
PlaceboPlacebo-
Primary Outcome Measures
NameTimeMethod
Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment.24 weeks
Secondary Outcome Measures
NameTimeMethod
Biomarker changes from baseline.baseline to 24 weeks
Change in background corticosteroid dose.baseline to 24 weeks
Time to treatment failure.24 weeks
Change in bleeding risk.baseline to 24 weeks
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.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.24 weeks
Percentage of subjects requiring rescue therapy.24 weeks
Safety profile (AEs, vitals signs, labs)24 weeks
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