A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Dupilumab Compared to Placebo in Japanese Patients With Atopic Dermatitis Aged 6 Months to <18 Years Whose Disease is Not Adequately Controlled With Existing Therapies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 62
- 试验地点
- 19
- 主要终点
- Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline EASI)
研究概览
简要总结
Primary Objective:
To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS)
Secondary Objective:
To evaluate the efficacy of dupilumab administered concomitantly with TCS. To assess the safety of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in participants.
To assess immunogenicity as determined by the incidence, titer, and clinical impact of treatment-emergent anti-drug antibodies (ADA) to dupilumab over time in pediatric patients with atopic dermatitis (AD) (aged ≥6 months to <18 years old) To assess the concentration of dupilumab in serum following administration concomitantly with TCS.
详细描述
For participant who declines to enter open-lebal extension (OLE), the duration of the study for each participant is approximately 33 weeks (including screening and follow-up) For participant choosing enter OLE, the duration is approximately 21 weeks (including screening) plus 3 years OLE period or until approval of the indication in Japan whichever is sooner.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 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
Dupilumab
Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks
干预措施: Dupilumab SAR231893 (Drug)
Placebo
Double dose on day1 and followed by single dose every 2 weeks or single dose every 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline EASI)
时间窗: At Week 16
The EASI is a composite index with scores ranging from 0 to 72.Higher scores indicates worse condition
次要结局
- Percent change in weekly average of daily worst itch numerical rating scale (NRS) for participants aged ≥6 years to <12 years old(From baseline to week 16)
- Percent change in EASI score(From baseline to week 16)
- Percent change in weekly average of daily worst scratch/itch NRS for participants aged ≥6 months to <6 years old(From baseline to week 16)
- Percent change for intensity of pruritus(From baseline to week 16)
- Change in percent body surface area (BSA) affected by atopic dermatitis (AD)(From baseline to week 16)
- Change in Children's Dermatology Life Quality Index (CDLQI) (≥4 years)(From baseline to week 16)
- Change in weekly average of daily worst scratch/itch NRS for participants aged ≥6 months to <6 years old(From baseline to week 16)
- Number of Participants With TEAEs, SAEs, and AESI From Baseline of open-label extension (OLE) Through the Last Study Visit(Week 16 to Week 116)
- Proportion of participants with Investigator's Global Assessment (IGA) 0 or 1(At Week 16)
- Proportion of participants with EASI-90 (≥90% improvement from baseline)(At Week 16)
- Change in weekly average of daily worst peak pruritus NRS for participants aged ≥12 years to <18 years old(From baseline to week 16)
- Number of Participants With Skin-Infection TEAEs (Excluding Herpetic Infections) From Baseline to 16 Weeks of Treatment(Baseline (Day 1) to Week 16)
- Percent change in weekly average of daily worst peak pruritus NRS for participants aged ≥12 years to <18 years old(From baseline to week 16)
- Proportion of participants with EASI-50 (≥50% improvement from baseline)(At Week 16)
- Change in Infants' Dermatitis Quality of Life Index (IDQOL) (<4 years)(From baseline to week 16)
- Change in Patient Oriented Eczema Measure (POEM)(From baseline to week 16)
- Change in weekly average of daily worst itch NRS for participants aged ≥6 years to <12 years old(From baseline to week 16)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interest (AESI) From Baseline to 16 Weeks of Treatment(Baseline (Day 1) to Week 16)
- Number of Participants With Treatment-emergent Anti-drug Antibody (ADA) to Dupilumab Over Time in Pediatric Participants with AD (Aged ≥6 Months to <18 Years old)(Baseline (Day 1) to Week 116)
- Serum Concentration of Dupilumab up to Week 116(Pre-dose at Baseline (Day 1), and Weeks 4, 12, 16, 24, 32, 52, 68, 92, and 116)