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ACTIVE NOT RECRUITING
NCT07216079
PHASE3

Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan

Sponsor: Sanofi

View on ClinicalTrials.gov

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

Interventions

DRUG

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