Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Key facts
- Where
- Albany, Ann Arbor, Boston, Clovis, Danvers, Greenville, Los Angeles, Minneapolis, New Orleans, Ogden, Peoria, Portland, Rochester, Seattle, The Bronx, Torrance, and Washington D.C., United StatesSee the 18 sites
- Phase
- Phase 3
Where in United States
- New York Oncology Hematology Site Number: 8400010Albany, United StatesTaking people
- University of Michigan Health - Michigan Medicine - University Hospital Site Number: 8400001Ann Arbor, United StatesTaking people
- Beth Israel Deaconess Medical Center Site Number: 8400019Boston, United StatesTaking people
- Massachusetts General Hospital Site Number: 8400004Boston, United StatesTaking people
- Community Health Partners (CHP) - Community Medical Oncology Specialists (University Oncology Associates) Site Number: 8400005Clovis, United StatesTaking people
- Mass General/North Shore Cancer Center Site Number: 8400020Danvers, United StatesTaking people
- East Carolina University Site Number: 8400003Greenville, United StatesTaking people
- University of Southern California (USC) Norris Comprehensive Cancer Center Site Number: 8400015Los Angeles, United StatesTaking people
- M Health Center for Bleeding and Clotting Disorders Site Number: 8400013Minneapolis, United StatesTaking people
- Tulane University Health Sciences Center - Tulane Avenue-Investigational Site Number: 8400011New Orleans, United StatesTaking people
- Community Cancer Trials of Utah Site Number: 8400002Ogden, United StatesTaking people
- Bleeding and Clotting Disorders Institute Site Number: 8400018Peoria, United StatesTaking people
- Oregon Health & Science University - Knight Cancer Institute Site Number: 8400006Portland, United StatesTaking people
- Rochester, MinnesotaHospital not named in the registryTaking people
- University of Washington Site Number: 8400008Seattle, United StatesTaking people
- Montefiore Medical Center-Investigational Site Number: 8400012The Bronx, United StatesTaking people
- The Lundquist Institute for Biomedical Innovation - Harbor-UCLA Medical Center Site Number: 8400017Torrance, United StatesTaking people
- MedStar Georgetown University Hospital Site Number: 8400014Washington D.C., United StatesTaking 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.