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

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)

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01609452

Enrollment

Registered

2012-06-01

Start date

2015-12-31

Completion date

Unknown

Last updated

2015-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenic Purpura

Keywords

Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Chronic ITP

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).

Interventions

BIOLOGICALBlisibimod

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

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.

Design outcomes

Primary

Measure	Time frame
Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment.	24 weeks

Secondary

Measure	Time frame
Biomarker changes from baseline.	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
Safety profile (AEs, vitals signs, labs)	24 weeks
Percentage of subjects requiring rescue therapy.	24 weeks
Time to treatment failure.	24 weeks
Change in bleeding risk.	baseline to 24 weeks
Change in background corticosteroid dose.	baseline to 24 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026