The KINSHIP Trial: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of AQX-1125 in Subjects With Atopic Dermatitis by Targeting the SHIP1 Pathway
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Lesion Symptom Score (TLSS)
研究概览
简要总结
The primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of AQX-1125 compared to placebo on change from baseline in Total Lesion Symptom Score in subjects with mild to moderate atopic dermatitis
详细描述
One of the causative factors for the inflammatory response observed in AD is the release of chemokines and other chemoattractant factors followed by recruitment of inflammatory cell subtypes (10). IL-16, a Langerhans cells (LC)-derived chemoattractant cytokine for CD4+ cells, RANTES, monocyte chemotactic protein (MCP-4) and eotaxin are overexpressed in epidermal keratinocytes from AD subjects and may contribute to the chemotaxis of eosinophils, macrophages and Th2-lymphocytes (11).
Since the activation of SHIP1 by AQX-1125 results in the inhibition of inflammatory cell chemotaxis and reduction of pro-inflammatory cytokine synthesis, this study hypothesized that AQX-1125 would improve AD.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged from 18 to 65 years old
- •Confirmed clinical diagnosis of active atopic dermatitis (AD) according to the Hanifin and Rajka criteria
- •At least a 6 months history of atopic dermatitis.
- •Body Surface Area (BSA) covered with atopic dermatitis of 1% or more
- •Mild or moderate atopic dermatitis (IGA score of 2 or 3).
- •TLSS of 5 or more at Day
- •Subject must use a non-medicated emollient daily for at least (≥) 7 days prior to Day 0 and should continue using that same emollient, at the same frequency, throughout the study.
排除标准
- •Female subject who is pregnant or breast-feeding
- •Unstable or clinically infected atopic dermatitis
研究组 & 干预措施
AQX-1125
1 x AQX-1125 Capsule daily
干预措施: AQX-1125 (Drug)
Placebo
1 x placebo capsule daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Total Lesion Symptom Score (TLSS)
时间窗: 12 weeks
The TLSS is an assessment of the severity of each of the following three signs: erythema, papulation/infiltration, excoriation and lichenification. Each of these items are rated using a 4-point scale severity where 0 is clear, 1 = mild, 2= moderate and 3 = severe. These ratings are then added to create a total score ranging from 0 to 12
次要结局
- Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score(12 weeks)
- Change From Baseline in Patient Oriented Eczema Measure (POEM) Score(12 weeks)
- Change From Baseline in Investigator's Global Assessment (IGA)(12 weeks)
- Change From Baseline in Eczema Area and Severity Index (EASI) Score(12 weeks)