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 (2) 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 primary ITP
• Participant received at least a first line therapy and had a history of response while on treatment
• Participant has loss of response, relapse or steroid dependency
Locations
United States
New York
New York Oncology Hematology_Investigational Site Number: 8400010
RECRUITING
Albany
Utah
Community Cancer Trials of Utah_Investigational Site Number: 8400002
RECRUITING
Ogden
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