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

Active Not RecruitingPhase 3

Sponsor: Sanofi

Conditions: Immune Thrombocytopenia

Interventions: rilzabrutinib

Countries: 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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (3)

Tsuchiura, Ibaraki, Japan
Kanazawa, Ishikawa-ken, Japan
Iruma-gun, Saitama, Japan