Trials / Active Not Recruiting
Active Not RecruitingNCT07216079
Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 4 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rilzabrutinib | Pharmaceutical form:Tablet-Route of administration:Oral |
Timeline
- Start date
- 2025-10-15
- Primary completion
- 2026-11-30
- Completion
- 2026-11-30
- First posted
- 2025-10-14
- Last updated
- 2025-11-06
Locations
3 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07216079. Inclusion in this directory is not an endorsement.