Status:
ACTIVE_NOT_RECRUITING
Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan
Lead Sponsor:
Sanofi
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 participant...
Eligibility Criteria
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.
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT07216079
Start Date
October 15 2025
End Date
November 30 2026
Last Update
November 6 2025
Active Locations (3)
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1
Investigational Site Number: 1001
Tsuchiura, Ibaraki, Japan, 300-0028
2
Investigational Site Number: 1002
Kanazawa, Ishikawa-ken, Japan, 920-8641
3
Investigational Site Number: 1003
Iruma-gun, Saitama, Japan, 350-0495