Overview
This is a multinational, open label, single arm study that will evaluate the impact of early multi-immune modulation with rilzabrutinib in adult ITP patients who failed first-line treatment. The study includes a screening period (up to 8 weeks), a primary analysis period (up to 28 weeks), a long-term extension period for selected participants (28 weeks) and a 24-week follow-up period only for eligible participants.
Eligibility
Key Inclusion Criteria:
- Male or female participants aged 18 years and older with primary ITP
- Participant received at least a first line therapy and had a history of response while on treatment
- Participant has loss of response, relapse or steroid dependency
Key Exclusion Criteria:
- Participants with Secondary ITP
- Participants with Evans syndrome or history of myelodysplastic syndrome
- Participants with history of lymphoma, leukemia, or any malignancy within the past 5 years except for non-melanoma skin malignancy.
- Participants with history of solid organ transplant
- Participants with history of coagulation or bleeding disorders other than ITP
- Participant received advanced therapy for ITP or was splenectomized
- Pregnancy or nursing The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.