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New oral drug shows promise for Long-Term control of rare bleeding disorder

NCT ID NCT07216079

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is for adults with chronic immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding and bruising. It tests the long-term safety and benefit of an oral drug called rilzabrutinib. Only 4 participants who already benefited from the drug in a prior study will continue treatment. The goal is to see if the drug remains safe and effective over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rilzabrutinib (oral tablet)
What this could lead to
If successful, this study could show that rilzabrutinib is a safe and effective long-term treatment option for managing chronic immune thrombocytopenia.
What could go wrong
This is a very small extension study (only 4 participants) with no placebo group, so results may not apply broadly. Long-term safety and effectiveness are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 4 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

autoimmune thrombocytopenic purpura Purpura, Thrombocytopenic, Idiopathic thrombocytopenia due to immune destruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immune thrombocytopenia

Contacts and locations

Locations

  • Investigational Site Number: 1001

    Tsuchiura, Ibaraki, 300-0028, Japan

  • Investigational Site Number: 1002

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Investigational Site Number: 1003

    Iruma-gun, Saitama, 350-0495, Japan

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