NCT07167758进行中（未招募）2 期
A Phase 2a, Randomized, Multicenter, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-509 in Adults With Moderate to Severe Atopic Dermatitis
Triveni Bio44 个研究点 分布在 7 个国家目标入组 95 人开始时间: 2025年8月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 95
- 试验地点
- 44
- 主要终点
- Percentage of participants with improvement of AD at Week 16
研究概览
简要总结
The goal of this interventional study is to learn if TRIV-509 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-509.
Participants will receive 4 doses of the study intervention that they are randomized to (TRIV-509 or placebo), and at Week 16 will cross over and receive 4 doses of the other study intervention.
The study duration for individual participants is up to 57 weeks, including a Screening period of up to 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has Atopic Dermatitis.
- •Has moderate to severe, active and symptomatic AD
排除标准
- •Severe or uncontrolled medical conditions.
- •Use of topical treatments, phototherapy, systemic immunosuppressives or immunomodulatory therapies, or immunomodulatory biologics, within stated washout periods.
研究组 & 干预措施
First TRIV-509 then Placebo
Experimental
干预措施: TRIV-509 (Drug)
First TRIV-509 then Placebo
Experimental
干预措施: Placebo (Drug)
First Placebo then TRIV-509
Experimental
干预措施: TRIV-509 (Drug)
First Placebo then TRIV-509
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of participants with improvement of AD at Week 16
时间窗: Baseline to Week 16
次要结局
- Percentage of participants with improvement of AD at Week 16(Baseline through Week 16)
- Percentage of participants with TEAEs.(For 16 Weeks)
- Percentage of participants with SAEs.(For 16 Weeks)
- Percentage of participants with anti-TRIV-509 antibodies(For 16 Weeks)
- Serum concentration of TRIV-509(For 16 Weeks)
研究者
研究点 (44)
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