Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan
Key facts
- Phase
- Phase 3
This trial has no sites in United States.
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Trial details
- Who runs it
- Sanofi
- Trial code
- NCT07216079
- Record updated
- 10 November 2026
- Original description
This is an open-label, multi-center, single group, Phase 3 study for treatment with rilzabrutinib.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.