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Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan
Sponsor: Sanofi
Summary
This is an open-label, multi-center, single group, Phase 3 study for treatment with rilzabrutinib. The purpose of this study is to provide continuation of rilzabrutinib treatment to adult participants with ITP who have completed the LTE of the LUNA 3 study in Japan, demonstrating clinically meaningful benefit as judged by the Investigator.
Official title: An Open-label Extension Study for Oral Rilzabrutinib in Adults With Chronic Immune Thrombocytopenia (ITP) Who Have Completed the Long-term Extension (LTE) of the LUNA 3 Study (PRN1008 018/EFC17093) in Japan
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4
Start Date
2025-10-15
Completion Date
2026-11-30
Last Updated
2025-11-06
Healthy Volunteers
No
Conditions
Interventions
rilzabrutinib
Pharmaceutical form:Tablet-Route of administration:Oral
Locations (3)
Investigational Site Number: 1001
Tsuchiura, Ibaraki, Japan
Investigational Site Number: 1002
Kanazawa, Ishikawa-ken, Japan
Investigational Site Number: 1003
Iruma-gun, Saitama, Japan