Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan
A legfontosabb adatok
- Fázis
- 3. fázis
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A vizsgálat adatai
- Ki végzi
- Sanofi
- Azonosító
- NCT07216079
- A regiszteradat frissítve
- 2026. november 10.
- Eredeti leírás
This is an open-label, multi-center, single group, Phase 3 study for treatment with rilzabrutinib.A teljes eredeti leírásKevesebb
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
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.
Bevonási feltételek: Participants who have been enrolled in and have completed the LTE of the LUNA 3 study with demonstration of efficacy without major safety concern while on study considered by the Investigator to be clinically meaningful; Participants who have ongoing diagnosis of primary ITP and continue to require treatment for ITP according to the Investigator; Participants who have acceptable benefit/risk profile; Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Kizáró feltételek: Participants with secondary ITP; Pregnant or lactating women; Electrocardiogram (ECG) findings for participants. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.