Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Key facts
- Where
- Budapest VIII, Debrecen, and Kaposvár, HungarySee the 3 sites
- Phase
- Phase 3
Where in Hungary
- Semmelweis UniversityBudapest VIII, HungaryTaking people
- University of DebrecenDebrecen, HungaryTaking people
- Somogy Vármegyei Kaposi Mór Oktató KórházKaposvár, HungaryTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sanofi
- Trial code
- NCT07007962EU 2025-522070-36-00
- Record updated
- 12 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Participant received advanced therapy for ITP or was splenectomized; 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; Participants with Secondary ITP; Pregnancy or nursing The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.