Immune ThrombocytopeniaPhase 3NCT07216079
Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan
A Phase 3 study testing rilzabrutinib in people with Immune Thrombocytopenia, run by Sanofi at 3 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- rilzabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesJapan
- Study dates
- 15 Oct 2025to 30 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Investigational Site Number: 1003
Iruma-gun, Saitama, 350-0495
Investigational Site Number: 1002
Kanazawa, Ishikawa-ken, 920-8641
Investigational Site Number: 1001
Tsuchiura, Ibaraki, 300-0028
About this study
Official title: An Open-label Extension Study for Oral Rilzabrutinib in Adults With Chronic Immune Thrombocytopenia (ITP) Who Have Completed the Long-term Extension (LTE) of the LUNA 3 Study (PRN1008 018/EFC17093) in Japan
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
- Being tested
- rilzabrutinib
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rilzabrutinibDrug
Also called SAR444671
Pharmaceutical form:Tablet-Route of administration:Oral
| Study group | Role | What they receive |
|---|---|---|
| Rilzabrutinib | Experimental | 400 mg Receives: Drug: rilzabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Until study completion, approximately 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start15 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216079
- Sponsor's protocol ID
- LTS19407
- Other IDs
- U1111-1319-5468
- Status last verified
- Nov 2025
- First submitted
- 9 Oct 2025
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study for Oral Rilzabrutinib in Adults With Chronic Immune Thrombocytopenia (ITP) Who Have Completed the Long-term Extension (LTE) of the LUNA 3 Study (PRN1008 018/EFC17093) in Japan
- ClinicalTrials.gov ID
- NCT07216079
- Acronym / sponsor ID
- LTS19407
- Conditions
- Immune Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rilzabrutinib | Experimental | Drug: rilzabrutinib400 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rilzabrutinibAlso: SAR444671Pharmaceutical form:Tablet-Route of administration:Oral | Drug | Rilzabrutinib |
Primary outcome
AEs including SAEs and AESIs
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- LTS19407 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rilzabrutinib in people with Immune Thrombocytopenia, run by Sanofi at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs including SAEs and AESIs (time frame: Until study completion, approximately 60 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.