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

July 28, 2015 updated by: Anthera Pharmaceuticals

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Experimental: Blisibimod
Biological: Blisibimod
Other Names:
  • A-623

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (Estimate)

June 1, 2012

Study Record Updates

Last Update Posted (Estimate)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-ITP3321

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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