|
Study participant must be ≥18 years of age at the time of the Screening Visit |
|
|
|
|
Study participant has a diagnosis of persistent (>3 months duration) or chronic (>12 months duration) primary immune thrombocytopenia (ITP) at the Screening Visit |
|
|
|
|
Study participant has a documented intolerance or insufficient response to two or more appropriate standard of care ITP treatments prior to Screening |
|
|
|
|
Study participants must have prior history of a response to a previous ITP therapy |
|
|
|
|
If taking allowed drugs, study participant must be on stable doses during defined time periods prior to Baseline (Day 1) |
|
|
|
|
Study participant has a documented history of low platelet count (<30×10^9/L) prior to Screening |
|
|
|
|
Study participant has a platelet count measurement at Screening and at Baseline (Day |
|
|
|
|
with an average of the two <30×10^9/L and no single count may be >35×10^9/L (using local laboratories) |
|
|
|
|
Study participant has a current or history of a peripheral blood smear consistent with |
|
|
|
|
Study participants may be male or female |
|
|
|
|
ITP |
|
|
|
|
A male participant must agree to use contraception during the Treatment Period and for at least 3 months after the final dose of study treatment and refrain from donating sperm during this period |
|
|
|
|
A female participant is eligible to participate if she is not pregnant as confirmed by a negative serum pregnancy test and not planning to get pregnant during the participation in the study, not breastfeeding, and at least one of the following conditions applies |
|
|
|
|
Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the |
|
|
|
|
contraceptive guidance during the Treatment Period and for at least 3 months after the dose |
|
|
|
|
of study treatment |
|
|
|
|
Participant has a history of arterial or venous thromboembolism (eg, stroke, transient
|
|
|
|
|
ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism)
|
|
|
|
|
within the 6 months prior to randomization or requires current anticoagulant treatment
|
|
|
|
|
Study participant has clinically significant bleeding that warrants immediate platelet
|
|
|
|
|
adjustment (eg, menorrhagia with significant drop in hemoglobin)
|
|
|
|
|
Study participant has a known hypersensitivity to any components of the study
|
|
|
|
|
medication or any other anti-neonatal Fc receptor (FcRn) medications
|
|
|
|
|
Study participant has evidence of a secondary cause of immune thrombocytopenia (clear
|
|
|
|
|
Study participant has a history of coagulopathy disorders other than ITP
|
|
|
|
|
association with other medical conditions, eg, untreated H. pylori infection
|
|
|
|
|
leukemia, lymphoma, common variable immunodeficiency, systemic lupus erythematosus
|
|
|
|
|
autoimmune thyroid disease or is drug induced), participant has a multiple immune
|
|
|
|
|
Study participant has a clinically relevant active infection (eg, sepsis, pneumonia
|
|
|
|
|
cytopenia (eg, Evan's syndrome)
|
|
|
|
|
or abscess) in the opinion of the investigator, or had a serious infection (resulting
|
|
|
|
|
in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior
|
|
|
|
|
to the first dose of investigational medicinal product (IMP)
|
|
|
|
|
Study participant with a known tuberculosis (TB) infection, at high risk of acquiring
|
|
|
|
|
TB infection, or latent tuberculosis infection (LTBI), or current/history of
|
|
|
|
|
nontuberculous mycobacterial infection (NTMBI)
|
|
|
|
|
Study participant has a history of a major organ transplant or hematopoietic stem
|
|
|
|
|
cell/marrow transplant
|
|
|
|
|
Study participant has experienced intracranial bleed in the last 6 months prior to the
|
|
|
|
|
Screening Visit
|
|
|
|
|
Study participant with current or medical history of immunoglobulin A (IgA)
|
|
|
|
|
deficiency, or a measurement of IgA <50 mg/dL at the Screening Visit
|
|
|
|
|
Study participant has undergone a splenectomy in the 2 years prior to the Baseline
|
|
|
|
|
Visit
|
|
|
|