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

NCT07216079 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: LTS19407U1111-1319-5468
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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 participants with ITP who have completed the LTE of the LUNA 3 study in Japan, demonstrating clinically meaningful benefit as judged by the Investigator.

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• AEs including SAEs and AESIs

  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

  Until study completion, approximately 60 weeks

Study Arms (1)

Rilzabrutinib

EXPERIMENTAL

400 mg

Drug: rilzabrutinib

Interventions

rilzabrutinib DRUG

Pharmaceutical form:Tablet-Route of administration:Oral

Also known as: SAR444671

Rilzabrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Investigational Site Number: 1001

Tsuchiura, Ibaraki, 300-0028, Japan

Location

Investigational Site Number: 1002

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Investigational Site Number: 1003

Iruma-gun, Saitama, 350-0495, Japan

Location

Related Links

• LTS19407 Plain Language Results Summary

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 14, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (3)