Sanofi
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. * Part…
Pharmaceutical form:Tablet-Route of administration:Oral