Immune Thrombocytopenia
Conditions
Interventions
Drug: Rilzabrutinib (SAR444671)
Pharmaceutical form: Tablet, Route of administration: Oral
Study Arm:
- Experimental: Rilzabrutinib 400 mg
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 |
|---|---|
| Adverse events (AEs) including serious adverse events (SAEs) and adverse events of special interest (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. | — |
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed