About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- rilzabrutinib