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

• 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 ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
• Change in background corticosteroid dose. [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]
• Percentage of subjects requiring rescue therapy. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Time to treatment failure. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Change in bleeding risk. [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]
• Safety profile (AEs, vitals signs, labs) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
• Biomarker changes from baseline. [ Time Frame: baseline to 24 weeks ] [ Designated as safety issue: No ]

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).

• Immune Thrombocytopenic Purpura
• Idiopathic Thrombocytopenic Purpura

• Biological: Blisibimod
  Other Name: A-623
• Other: Placebo

• Experimental: Blisibimod
  Intervention: Biological: Blisibimod
• Placebo Comparator: Placebo
  Intervention: Other: Placebo

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.