A Phase 1/2b, Multiple Dose and 12-Week, Parallel Group, Double Blind, Dose Ranging, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.1% and ARQ-252 Cream 0.3% in Subjects With Chronic Hand Eczema
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 36
- 主要终点
- Cohort 1: Number of Participants With an Application Site Reaction
研究概览
简要总结
This study will assess the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema
详细描述
This is a Phase 1/2b multiple dose, parallel group, double blind, vehicle-controlled study of the safety and efficacy of ARQ-252 cream in subjects with chronic hand eczema
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ARQ-252 cream 0.3% BID (twice daily)
Active Comparator
干预措施: ARQ-252 cream 0.3% (Drug)
ARQ-252 cream 0.3% QD (once daily)
Active Comparator
干预措施: ARQ-252 cream 0.3% (Drug)
ARQ-252 cream 0.1% QD (once daily)
Active Comparator
干预措施: ARQ-252 cream 0.1% (Drug)
Vehicle cream BID (twice daily)
Placebo Comparator
干预措施: ARQ-252 Vehicle Cream (Drug)
Vehicle cream QD (once daily)
Placebo Comparator
干预措施: ARQ-252 Vehicle Cream (Drug)
结局指标
主要结局
Cohort 1: Number of Participants With an Application Site Reaction
时间窗: Up to 3 weeks
The number of Cohort 1 participants with AEs coded as application site events is reported.
Cohort 1: Number of Participants With ≥1 Serious Adverse Event (SAE)
时间窗: Up to 3 weeks
The number of Cohort 1 participants with an SAE is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health.
Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters
时间窗: Up to 3 weeks
The number of Cohort 1 participants with a significant change in hematology is reported.
Cohort 1: Number of Participants With ≥1 Adverse Event (AE)
时间窗: Up to 3 weeks
The number of Cohort 1 participants with an AE is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research.
Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12
时间窗: Week 12
The IGA is 5-point scale assessing the severity of hand eczema; scores range from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' at Week 12 is presented.
Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters
时间窗: Up to 3 weeks
The number of Cohort 1 participants with a significant change in chemistry is reported.
次要结局
- Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score(Weeks 2, 4, 8, and 12)
- Cohort 2: Achievement of ≥4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score(Weeks 2, 4, 8, and 12)
- Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline(Weeks 2, 4, 8 and 12)
- Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline(Weeks 2, 4, 8 and 12)
- Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score(Weeks 2, 4, 8, and 12)
- Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score(Weeks 2, 4, 8, and 12)
- Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit(Weeks 2, 4, 8, 12, 13)
- Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'(Weeks 2, 4, and 8)
- Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score(Weeks 2, 4, 8, and 12)
- Cohort 2: The Rate of Achievement of ≥4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score(Weeks 2, 4, 8, and 12)
- Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease(Weeks 2, 4, 8, 12)