NCT04989517已完成1 期
A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of AT193 in the Treatment of Patients With Hidradenitis Suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 7
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group phase 1b study to evaluate AT193 in approximately 44 participants with HS. The treatment period will be 8 weeks followed by a 2-week nontreatment follow-up. The primary objective of this study is to evaluate the safety and tolerability of AT193. The secondary objectives of this study are to evaluate the preliminary efficacy in the treatment of HS.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HS or signs and symptoms consistent with HS for at least 3 months before screening in the judgment of the investigator.
- •Stable disease for at least 2 months before screening in the judgment of the investigator.
- •A woman of childbearing potential must use appropriate contraceptive measures during the study period.
- •A woman of childbearing potential must have a negative urine pregnancy test result at screening.
- •Written informed consent must be obtained before any study procedure is performed.
排除标准
- •Pregnant or breastfeeding.
- •Any active skin disease that may interfere with evaluation of study drug or outcome assessment.
- •History or evidence of a clinically significant disorder, condition, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator.
- •Change in smoking or marijuana history within 3 months before Day 1 or planned during study period.
研究组 & 干预措施
AT193
Experimental
Topical applied daily
干预措施: AT193 (Drug)
Placebo
Placebo Comparator
Topical applied daily
干预措施: AT193 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: 10 weeks
次要结局
未报告次要终点
研究者
研究点 (7)
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