NCT07216079进行中（未招募）3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- AEs including SAEs and AESIs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Rilzabrutinib
Experimental
400 mg
干预措施: rilzabrutinib (Drug)
结局指标
主要结局
AEs including SAEs and AESIs
时间窗: 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
次要结局
未报告次要终点
研究者
研究点 (3)
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