A Multi-center, Exploratory Study to Assess Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- Percentage of Participants With Change From Baseline in Nerve Fiber Branching on Lesional Skin at Week 17
研究概览
简要总结
Primary Objective:
- Assess change in neuronal architecture following long term treatment with dupilumab in skin biopsies from atopic dermatitis (AD) participants with chronic pruritus.
Secondary Objectives:
- Assess change in neuronal architecture following short term treatment with dupilumab and during follow-up in skin biopsies from AD participants with chronic pruritus.
- To evaluate the efficacy of dupilumab in AD participants with chronic pruritus.
- To evaluate the safety of dupilumab in adult participants with moderate-to-severe AD.
详细描述
AD participants: A 20-week Observation Period including 16 weeks of treatment for AD participants and a 4-week follow-up period; Healthy participants: 8 days observation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Participants With AD: Dupilumab
Participants with moderate to severe AD received dupilumab 600 milligrams (mg) subcutaneous (SC) injection on Day 1, followed by dupilumab 300 mg SC injection every 2 weeks (Q2W) from Week 3 to Week 15.
干预措施: Dupilumab (SAR231893) (Drug)
结局指标
主要结局
Percentage of Participants With Change From Baseline in Nerve Fiber Branching on Lesional Skin at Week 17
时间窗: Baseline, Week 17
Skin biopsies were used to analyze the epidermal nerve fiber branching. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker PGP9.5; and the basement membrane was visualized by staining for collagen type 4. Branching of epidermal nerve fibers was assessed semi-quantitatively by classifying participants into 4 groups depending on the predominant intraepidermal nerve fiber branching pattern as follows: only linear (100% linear), mainly linear (\>60% linear), mainly branched (\>60% branched), only branched (100% branched). Percentage of participants with change in nerve fiber branching status from baseline on lesional skin at Week 17 are reported in this outcome measure.
Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Week 17
时间窗: Baseline, Week 17
Skin biopsies were used to analyze the epidermal nerve fiber density. Nerve fibers were visualized by staining consecutive sections for the pan-axonal marker protein gene product 9.5 (PGP9.5); and the basement membrane was visualized by staining for collagen type 4. Quantification of intraepidermal nerve fiber density was calculated by assessing nerve fibers crossing the basement membrane per square millimeter (F/mm\^2). Data for this outcome measure was not planned to be collected and analyzed for "healthy participant" arm as pre-specified in protocol.
次要结局
- Change From Baseline in Nerve Fiber Branching on Lesional Skin at Weeks 3 and 21(Baseline, Weeks 3 and 21)
- Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Weeks 17 and 21(Baseline, Weeks 17 and 21)
- Change From Baseline in Peak Pruritus Assessed by Numeric Rating Scale (NRS) Scores at Weeks 17 and 21(Baseline, Weeks 17 and 21)
- Change From Baseline in Atopic Dermatitis Control Tool (ADCT) Total Score at Weeks 17 and 21(Baseline, Weeks 17 and 21)
- Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Weeks 17 and 21(Baseline, Weeks 17 and 21)
- Change From Baseline in Intraepidermal Nerve Fiber Density on Lesional Skin at Weeks 3 and 21(Baseline, Weeks 3 and 21)
- Change From Baseline in Patient-Reported Outcomes Measurement Information (PROMIS-itch) Itch-Severity Total Score at Weeks 17 and 21(Baseline, Weeks 17 and 21)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 17 and 21(Baseline, Weeks 17 and 21)
- Change From Baseline in Eczema and Severity Index (EASI) Total Score at Weeks 17 and 21(Baseline, Weeks 17 and 21)
- Change From Baseline in Sleep Quality Numerical Rating Scale Score at Weeks 17 and 21(Baseline, Weeks 17 and 21)
- Change From Baseline in Skin Sensitivity Numerical Rating Scale Score at Weeks 17 and 21(Baseline, Weeks 17 and 21)
- Change From Baseline in Skin Pain Numerical Rating Scale Score at Weeks 17 and 21(Baseline, Weeks 17 and 21)
- Percentage of Participants With Change of Greater Than or Equal to (>=4) Point in Pruritus Numerical Rating Scale From Baseline at Weeks 17 and 21(Baseline, Weeks 17 and 21)
- Change From Baseline in Skin Burning Numerical Rating Scale Score at Weeks 17 and 21(Baseline, Weeks 17 and 21)