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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2015
• Main ID: NCT01609452
• Date of registration: 23/05/2012
• Prospective Registration: Yes
• Primary sponsor: Anthera Pharmaceuticals
• Public title: MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITP
• Scientific 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)
• Date of first enrolment: December 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01609452
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Immune Thrombocytopenic Purpura

Idiopathic Thrombocytopenic Purpura

Intervention(s)

Biological: Blisibimod

Other: Placebo

Primary Outcome(s)

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(s)

Biomarker changes from baseline. [Time Frame: baseline to 24 weeks]

Change in background corticosteroid dose. [Time Frame: baseline to 24 weeks]

Safety profile (AEs, vitals signs, labs) [Time Frame: 24 weeks]

Change in bleeding risk. [Time Frame: baseline to 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]

Time to treatment failure. [Time Frame: 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. [Time Frame: 24 weeks]

Percentage of subjects requiring rescue therapy. [Time Frame: 24 weeks]

Secondary ID(s)

AN-ITP3321

Source(s) of Monetary Support

Please refer to primary and secondary sponsors