drugset / Trial / NCT07007962

Study to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment

NCT07007962

Phase 3 Recruiting 60 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-10-24
Primary completion
2027-11-05
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Rilzabrutinib Small molecule 400 mg Oral