Oral rilzabrutinib for adults with immune thrombocytopenia after first-line treatment fails.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multinational, open-label, single-arm Phase 3 study gives oral rilzabrutinib to adults with primary ITP who relapsed, lost response, or are steroid-dependent after first-line treatment. After a screening period of up to 8 weeks, participants enter a primary analysis period of up to 28 weeks to monitor platelet responses and safety, with a selected long-term extension of 28 weeks and a 24-week follow-up for eligible participants. Key exclusions include secondary ITP, Evans syndrome, prior splenectomy, prior advanced ITP therapy, certain recent malignancies, and pregnancy or nursing. The trial is sponsored by Sanofi and is being conducted at several academic medical centers in the United States.

Why it matters

Who can join: the full rules

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.

Where it's running

• Community Health Partners (CHP) - Community Medical Oncology Specialists (University Oncology Associates)
  Clovis, California, United States Recruiting
• University of Southern California (USC)
  Los Angeles, California, United States Recruiting
• Tulane University Health Sciences Center - Tulane Avenue-Investigational Site Number: 8400011
  New Orleans, Louisiana, United States Recruiting
• Massachusetts General Hospital Cancer Center
  Boston, Massachusetts, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Mass General Brigham Cancer Institute
  Danvers, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Rilzabrutinib in adults with severe kidney impairment vs. normal kidney function

  This study tests how rilzabrutinib behaves in the body and its safety in adults with severe kidney impairment compared to healthy adults.

  Recruiting Phase 1 Sanofi · Hialeah, Florida · NCT07853131

• Sirolimus added to standard therapy for adults with SLE-associated immune thrombocytopenia

  This trial tests whether adding sirolimus to usual treatment helps adults with SLE-related immune thrombocytopenia see their platelet counts improve.

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• GL-2045 safety and blood-count help for adults with ITP

  GL-2045 is being tested in adults with immune thrombocytopenia to see if it can safely raise platelet counts like IVIg does.

  Recruiting Phase 1 Gliknik Inc. · Leeds · NCT07605845

• Eltrombopag use in adults with primary ITP: real-world patterns and outcomes

  This study looks at how eltrombopag is used in adult patients with primary ITP and what outcomes are seen in routine care.

  Recruiting Novartis · Basel · NCT07587723

• Daratumumab versus rituximab for children with primary immune thrombocytopenia

  This study will test whether daratumumab works better than rituximab to increase platelet counts in children aged 6–17 with primary ITP who did not respond to or relapsed after steroid treatment.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT07362238

• Daratumumab plus rituximab for adults with relapsed or refractory immune thrombocytopenia

  This treatment combines daratumumab (an anti‑CD38 antibody) with rituximab to see if it raises platelet counts in adults with ITP who haven't responded to steroids and other therapies.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07362199

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.