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

Sanofi

Status and phase

Active, not recruiting

Phase 3

Conditions

Immune Thrombocytopenia

Treatments

Drug: rilzabrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT07216079

LTS19407

U1111-1319-5468 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

4 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.