Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Recruiting now · Phase 3
Conditions studied: Immune Thrombocytopenia
In brief
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 facts
- Study ID
- NCT07007962
- Run by
- Sanofi
- People needed
- 60
- Starts
- 2025-10-24
- Expected to finish
- 2028-12-30
- Last updated by the study team
- 2026-06-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Community Health Partners (CHP) - Community Medical Oncology Specialists (University Oncology Associates) — Clovis, California, United States (enrolling)
- University of Southern California (USC) — Los Angeles, California, United States (enrolling)
- Tulane University Health Sciences Center - Tulane Avenue-Investigational Site Number: 8400011 — New Orleans, Louisiana, United States (enrolling)
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Mass General Brigham Cancer Institute — Danvers, Massachusetts, United States (enrolling)
- University of Michigan Health - Michigan Medicine - University Hospital-Investigational Site Number: 8400001 — Ann Arbor, Michigan, United States (enrolling)
- Mayo Clinic_Investigational Site Number: 8400009 — Rochester, Minnesota, United States (enrolling)
- New York Oncology Hematology-Investigational Site Number: 8400010 — Albany, New York, United States (enrolling)
- Montefiore Medical Center-Investigational Site Number: 8400012 — The Bronx, New York, United States (enrolling)
- Oregon Health and Sciences University — Portland, Oregon, United States (enrolling)
- Community Cancer Trials of Utah-Investigational Site Number: 8400002 — Ogden, Utah, United States (enrolling)
- Investigational Site Number : 0400001 — Vienna, Austria (enrolling)
- Investigational Site Number : 2030002 — Prague, Czechia (enrolling)
- Investigational Site Number: 2500003 — Créteil, France (enrolling)
- Investigational Site Number : 2500001 — Dijon, France (enrolling)
- Investigational Site Number : 2500002 — Pessac, France (enrolling)
- Investigational Site Number : 2500004 — Toulouse, France (enrolling)
- Investigational Site Number : 2760004 — Leipzig, Germany (enrolling)
- Investigational Site Number : 3480001 — Budapest, Hungary (enrolling)
- Investigational Site Number : 3480002 — Kaposvár, Hungary (enrolling)
- Investigational Site Number : 3800002 — Meldola, Italy (enrolling)
- Investigational Site Number : 3800004 — Milan, Italy (enrolling)
- Investigational Site Number : 3800006 — Naples, Italy (enrolling)
- Investigational Site Number : 3800007 — Torino, Italy (enrolling)
Full record on ClinicalTrials.gov
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