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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Achievement of a durable platelet response of 50 billion platelets per liter or higher over the last weeks of treatment.
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
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
Change in background corticosteroid dose.
Time frame: baseline to 24 weeks
Percentage of subjects requiring rescue therapy.
Time frame: 24 weeks
Time to treatment failure.
Time frame: 24 weeks
Change in bleeding risk.
Time frame: baseline to 24 weeks
Safety profile (AEs, vitals signs, labs)
Time frame: 24 weeks
Biomarker changes from baseline.
Time frame: baseline to 24 weeks
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