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Clinical Trials in Japan / NCT07216079
Active, not recruiting Phase 3

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

NCT07216079 · tracked via the Priya Life Science Japan tracker
Sponsor
Sanofi
Phase
Phase 3
Started
2025-10-15
Last updated
2025-11-06

Condition(s) studied

Immune Thrombocytopenia

Investigational drug(s) / intervention(s)

rilzabrutinib →

rilzabrutinib: Pharmaceutical form:Tablet-Route of administration:Oral

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • AEs including SAEs and AESIs — Until study completion, approximately 60 weeks
    An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor is required

Trial sites (3)

FacilityCityRegionStatus
Investigational Site Number: 1001 Tsuchiura Ibaraki
Investigational Site Number: 1002 Kanazawa Ishikawa-ken
Investigational Site Number: 1003 Iruma-gun Saitama

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07216079 on ClinicalTrials.gov ↗ ← All trials in Japan