Immune Thrombocytopenia
Conditions
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.
Interventions
DRUGrilzabrutinib
Pharmaceutical form:Tablet-Route of administration:Oral
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AEs including SAEs and AESIs | 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 |
Countries
Japan
Outcome results
None listed