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Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment
Sponsor: Sanofi
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-10-24
Completion Date
2028-12-30
Last Updated
2026-06-22
Healthy Volunteers
No
Conditions
Interventions
rilzabrutinib
Pharmaceutical form:Tablet-Route of administration:Oral
Locations (36)
Community Health Partners (CHP) - Community Medical Oncology Specialists (University Oncology Associates)
Clovis, California, United States
University of Southern California (USC)
Los Angeles, California, United States
Tulane University Health Sciences Center - Tulane Avenue-Investigational Site Number: 8400011
New Orleans, Louisiana, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mass General Brigham Cancer Institute
Danvers, Massachusetts, United States
University of Michigan Health - Michigan Medicine - University Hospital-Investigational Site Number: 8400001
Ann Arbor, Michigan, United States
Mayo Clinic_Investigational Site Number: 8400009
Rochester, Minnesota, United States
New York Oncology Hematology-Investigational Site Number: 8400010
Albany, New York, United States
Montefiore Medical Center-Investigational Site Number: 8400012
The Bronx, New York, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Community Cancer Trials of Utah-Investigational Site Number: 8400002
Ogden, Utah, United States
Investigational Site Number : 0400001
Vienna, Austria
Investigational Site Number : 2030002
Prague, Czechia
Investigational Site Number: 2500003
Créteil, France
Investigational Site Number : 2500001
Dijon, France
Investigational Site Number : 2500002
Pessac, France
Investigational Site Number : 2500004
Toulouse, France
Investigational Site Number : 2760004
Leipzig, Germany
Investigational Site Number : 3480001
Budapest, Hungary
Investigational Site Number : 3480002
Kaposvár, Hungary
Investigational Site Number : 3800002
Meldola, Italy
Investigational Site Number : 3800004
Milan, Italy
Investigational Site Number : 3800006
Naples, Italy
Investigational Site Number : 3800007
Torino, Italy
Investigational Site Number : 3800003
Vicenza, Italy
Investigational Site Number : 6160002
Gdansk, Poland
Investigational Site Number : 6160003
Skorzewo, Poland
Investigational Site Number : 6160004
Słupsk, Poland
Investigational Site Number : 7240001
Barcelona, Spain
Investigational Site Number : 7240002
Burgos, Spain
Investigational Site Number : 7240007
Madrid, Spain
Investigational Site Number : 7240008
Madrid, Spain
Investigational Site Number : 7240005
Murcia, Spain
Investigational Site Number : 7240003
San Cristóbal de La Laguna, Spain
Investigational Site Number : 7240004
Seville, Spain