Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

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.

Key Inclusion Criteria:

• Male or female participants aged 18 years and older with a documented diagnosis of primary ITP in the medical history
• Participant received at least one course of 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, including genetic conditions, 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.