NCT06025110终止2 期
A 12-month, Randomized, Single-blind, Placebo-controlled Exposure-response Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients (STRIDE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- ITB-Med LLC
- 入组人数
- 9
- 试验地点
- 26
- 主要终点
- Change from baseline in beta-cell function as compared to placebo at week 52.
研究概览
简要总结
The goal of this study is to determine if treatment with TCD601 improves beta-cell function in adults recently diagnosed with type 1 diabetes compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the study requirements and provide written informed consent before any study assessment is performed
- •Male or female patients ≥ 18 to 45 years of age
- •A diagnosis of type 1 diabetes
排除标准
- •Women who are pregnant, lactating, or planning on pregnancy during the study
- •History of cancer
- •History of heart disease
- •Recent infection
研究组 & 干预措施
TCD601
Experimental
Administered one of three doses of TCD601 over a 12 week treatment period.
干预措施: TCD601 (Biological)
Placebo
Placebo Comparator
Placebo is administered over a 12 week treatment period.
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in beta-cell function as compared to placebo at week 52.
时间窗: 52 weeks
Assess any changes in beta-cell function at the end of the study (week 52) for patients treated with TCD601 (study drug) compared to subjects treated with placebo (the comparator).
次要结局
- Assess the incidence and severity of adverse(52 weeks)
研究者
研究点 (26)
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