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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
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
rilzabrutinib
Pharmaceutical form:Tablet-Route of administration:Oral
Locations (20)
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
Community Cancer Trials of Utah_Investigational Site Number: 8400002
Ogden, Utah, United States
Investigational Site Number : 0400001
Vienna, Austria
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 : 3480002
Kaposvár, Hungary
Investigational Site Number : 3800006
Naples, 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 : 7240002
Burgos, Spain
Investigational Site Number : 7240008
Madrid, Spain
Investigational Site Number : 7240005
Murcia, Spain
Investigational Site Number : 7240004
Seville, Spain