NCT06585202已完成2 期
A Phase 2a Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Efficacy, and Pharmacodynamics of ATI-2138 Administered Over 12 Weeks in Participants With Moderate to Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Incidence and severity of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This is a Phase 2 open label study of ATI-2138 in participants with moderate to severe atopic dermatitis.
详细描述
This open-label, single-arm study of ATI-2138 in moderate to severe AD participants between the ages of 18 and 60 years (inclusive) will investigate the safety, tolerability, pharmacokinetics, efficacy and pharmacodynamics of ATI-2138 administered over 12 weeks.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures.
- •Male patients or non-pregnant, non-nursing female patients 18 to 60 years old, inclusive, at the time of informed consent/assent.
- •Have at least a 1-year history of moderate or severe AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit as determined by the Investigator upon review of participant medical history.
排除标准
- •Any prior exposure to systemic (oral) JAK inhibitors or TYK inhibitors at any time prior to Screening.
- •Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period.
- •Refractory AD (ie, AD that required frequent hospitalizations and/or frequent intravenous treatment for skin infections within the year before the Screening Visit).
- •Concomitant skin disease or clinically infected AD or presence of other skin disease in the area to be dosed that may interfere with study assessments.
- •Female patients who are pregnant, nursing, or planning to become pregnant during the study.
研究组 & 干预措施
ATI-2138
Experimental
ATI-2138 oral tablets BID
干预措施: ATI-2138 (Drug)
结局指标
主要结局
Incidence and severity of treatment emergent adverse events (TEAEs)
时间窗: From baseline up to two weeks after treatment (Day 98)
次要结局
- Change from baseline Eczema Area and Severity Index (EASI) Over Time(Up to Week 12)
- Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time(Up to Week 12)
- Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time(Up to Week 12)
- Change from baseline in AD Body Surface Area (BSA) over time(Up to week 12)
- Change in IGA score over time(Up to Week 12)
- Change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) over time(Up to Week 12)
- ATI-2138 trough concentration ng/mL(Day 1 to Week 12)
- ATI-2138 peak concentration (Cmax) ng/mL(Day 1 to Week 12)
研究者
研究点 (6)
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