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
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Community Health Partners (CHP) - Community Medical Oncology Specialists (University Oncology Associates)
RECRUITING
Clovis
University of Southern California (USC)
RECRUITING
Los Angeles
Louisiana
Tulane University Health Sciences Center - Tulane Avenue-Investigational Site Number: 8400011
RECRUITING
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Mass General Brigham Cancer Institute
RECRUITING
Danvers
Michigan
University of Michigan Health - Michigan Medicine - University Hospital-Investigational Site Number: 8400001
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic_Investigational Site Number: 8400009
RECRUITING
Rochester
New York
New York Oncology Hematology-Investigational Site Number: 8400010
RECRUITING
Albany
Montefiore Medical Center-Investigational Site Number: 8400012
RECRUITING
The Bronx
Oregon
Oregon Health and Sciences University
RECRUITING
Portland
Utah
Community Cancer Trials of Utah-Investigational Site Number: 8400002
RECRUITING
Ogden
Other Locations
Austria
Investigational Site Number : 0400001
RECRUITING
Vienna
France
Investigational Site Number: 2500003
RECRUITING
Créteil
Investigational Site Number : 2500001
RECRUITING
Dijon
Investigational Site Number : 2500002
RECRUITING
Pessac
Investigational Site Number : 2500004
RECRUITING
Toulouse
Germany
Investigational Site Number : 2760004
RECRUITING
Leipzig
Hungary
Investigational Site Number : 3480001
RECRUITING
Budapest
Investigational Site Number : 3480002
RECRUITING
Kaposvár
Italy
Investigational Site Number : 3800002
RECRUITING
Meldola
Investigational Site Number : 3800004
RECRUITING
Milan
Investigational Site Number : 3800006
RECRUITING
Naples
Investigational Site Number : 3800007
RECRUITING
Torino
Investigational Site Number : 3800003
RECRUITING
Vicenza
Poland
Investigational Site Number : 6160002
RECRUITING
Gdansk
Investigational Site Number : 6160003
RECRUITING
Skorzewo
Investigational Site Number : 6160004
RECRUITING
Słupsk
Spain
Investigational Site Number : 7240001
RECRUITING
Barcelona
Investigational Site Number : 7240002
RECRUITING
Burgos
Investigational Site Number : 7240007
RECRUITING
Madrid
Investigational Site Number : 7240008
RECRUITING
Madrid
Investigational Site Number : 7240005
RECRUITING
Murcia
Investigational Site Number : 7240003
RECRUITING
San Cristóbal De La Laguna
Investigational Site Number : 7240004
RECRUITING
Seville
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-10-24
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 60
Treatments
Experimental: rilzabrutinib
400 mg BID
Related Therapeutic Areas
Sponsors
Leads: Sanofi