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

Primary Purpose

Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Blisibimod

Placebo

About this trial

This is an interventional treatment trial for Immune Thrombocytopenic Purpura focused on measuring Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Chronic ITP

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Blisibimod

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Achievement of a transient improvement in platelet count of 50 billion platelets per liter or higher at any 4 weeks of the treatment period.

Change in background corticosteroid dose.

Percentage of subjects requiring rescue therapy.

Time to treatment failure.

Change in bleeding risk.

Safety profile (AEs, vitals signs, labs)

Biomarker changes from baseline.

Full Information

NCT ID

NCT01609452

First Posted

May 23, 2012

Last Updated

July 28, 2015

Sponsor

Anthera Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01609452

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Withdrawn

Study Start Date

December 2015 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anthera Pharmaceuticals

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura

Keywords

Immune Thrombocytopenic Purpura, Idiopathic Thrombocytopenic Purpura, Chronic ITP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Blisibimod

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Blisibimod

Other Intervention Name(s)

A-623

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Change in background corticosteroid dose.

Time Frame

baseline to 24 weeks

Title

Percentage of subjects requiring rescue therapy.

Time Frame

24 weeks

Title

Time to treatment failure.

Time Frame

24 weeks

Title

Change in bleeding risk.

Time Frame

baseline to 24 weeks

Title

Safety profile (AEs, vitals signs, labs)

Time Frame

24 weeks

Title

Biomarker changes from baseline.

Time Frame

baseline to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

12. IPD Sharing Statement

Learn more about this trial

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

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