A Phase 2 Study to Evaluate the Efficacy and Safety of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall response rate (4 weeks)
研究概览
简要总结
This is a Phase 2, open-label, randomized, multicenter study to assess the efficacy and safety of DZD8586 in patients with primary immune thrombocytopenia (ITP). The target population of this study is patients with primary ITP who had failed to respond or relapsed after receiving at least one standard therapy. Participants who meet the inclusion criteria and do not meet the exclusion criteria will be randomized to different dose groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male and female participants ≥ 18 years of age.
- •Diagnosed with persistent or chronic primary ITP, and an average of two platelet counts < 30 × 10⁹/L.
- •Have failed at least one standard treatment for ITP (glucocorticoids and/or IVIG).
- •Adequate bone marrow reserve and organ functions.
- •Willing to comply with contraceptive restrictions.
排除标准
- •Have evidence of secondary causes of immune thrombocytopenia.
- •Have a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
- •Any of previous or current treatment prohibited by protocol.
- •Any of severe cardiac abnormalities.
- •Active infection.
- •Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
- •Known allergy to DZD8586 drug excipients or other chemical analogues.
- •Pregnant or breastfeeding female participants.
研究组 & 干预措施
DZD8586 dose level 1
Administered orally, once daily.
干预措施: DZD8586 dose level 1 (Drug)
DZD8586 dose level 2
Administered orally, once daily.
干预措施: DZD8586 dose level 2 (Drug)
DZD8586 dose level 3
Administered orally, once daily.
干预措施: DZD8586 dose level 3 (Drug)
结局指标
主要结局
Overall response rate (4 weeks)
时间窗: within 4 weeks
The proportion of patients with platelet counts ≥ 50 × 10⁹/L on 2 consecutive visits (with an interval of at least 7 days) within 4 weeks.
次要结局
- Incidence and severity of Adverse Events (AEs)(30 days after the last dose)
- Overall response rate (12 weeks)(within 12 weeks)
- Durable response rate(within 24 weeks)
- Time to response(within 24 weeks)