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 (20) 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
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
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
Hungary
Investigational Site Number : 3480002
RECRUITING
Kaposvár
Italy
Investigational Site Number : 3800006
RECRUITING
Naples
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 : 7240002
RECRUITING
Burgos
Investigational Site Number : 7240008
RECRUITING
Madrid
Investigational Site Number : 7240005
RECRUITING
Murcia
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