Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan
NCT ID: NCT07216079
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
4 participants
INTERVENTIONAL
2025-10-15
2026-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rilzabrutinib
400 mg
rilzabrutinib
Pharmaceutical form:Tablet-Route of administration:Oral
Interventions
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rilzabrutinib
Pharmaceutical form:Tablet-Route of administration:Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Investigational Site Number: 1001
Tsuchiura, Ibaraki, Japan
Investigational Site Number: 1002
Kanazawa, Ishikawa-ken, Japan
Investigational Site Number: 1003
Iruma-gun, Saitama, Japan
Countries
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Related Links
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LTS19407 Plain Language Results Summary
Other Identifiers
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U1111-1319-5468
Identifier Type: REGISTRY
Identifier Source: secondary_id
LTS19407
Identifier Type: -
Identifier Source: org_study_id