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

Sponsor

Anthera Pharmaceuticals (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01609452

Collaborator

(none)

Enrollment

Arms

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura	Biological: Blisibimod Other: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Blisibimod

Biological: Blisibimod

Other Names:

A-623

Placebo Comparator: Placebo

Other: Placebo

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.