Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier Function in Pediatric Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 41
- 试验地点
- 3
- 主要终点
- Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Participants at Week 16
研究概览
简要总结
Primary Objective:
- Evaluate changes in skin barrier function with transepidermal water loss (TEWL) assessed after skin tape stripping (STS) in predefined lesional skin in pediatric participants with moderate to severe atopic dermatitis (AD) treated with dupilumab.
Secondary Objectives:
- Evaluate changes in skin barrier function with TEWL assessed after STS in predefined lesional and non-lesional skin in pediatric participants with moderate to severe AD treated with dupilumab in reference to normal skin of healthy volunteers.
- Evaluate time course of change in skin barrier function with TEWL assessed before and after STS in predefined lesional and non-lesional skin in pediatric participants with moderate to severe AD during dupilumab treatment phase and follow-up period in reference to normal skin of healthy volunteers.
详细描述
Total study duration including screening and follow-up was 32 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 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
Atopic Dermatitis Participants
Pediatric participants with moderate-to-severe atopic dermatitis (AD) and with baseline body weight more than or equal to (>=) 15 kilograms (kg) and less than (<) 30 kg received a subcutaneous (SC) loading dose of dupilumab 600 milligrams (mg) (2 injections of dupilumab 300 mg) on Day 1 (Week 0) followed by dupilumab 300 mg SC injection every 4 weeks (Q4W), from Week 4 to Week 12. Pediatric participants with body weight >=30 kg and <60 kg received SC loading dose of dupilumab 400 mg (2 injections of dupilumab 200 mg) on Day 1 (Week 0), followed by dupilumab 200 mg SC injection every 2 weeks (Q2W), from Week 2 to Week 14.
干预措施: Dupilumab SAR231893 (Drug)
结局指标
主要结局
Percent Change From Baseline in Transepidermal Water Loss (TEWL) After 5 Skin Tape Stripping (STS) on Lesional Skin (LS) in AD Participants at Week 16
时间窗: Baseline, Week 16
TEWL assessment: a noninvasive in vivo measurement of water loss across stratum corneum that is used to characterize skin barrier function (SBF). TEWL combined with STS measures SBF. With STS, the uppermost layers of the skin are peeled away using adhesive discs. Lesional skin (LS) areas for TEWL assessment and STS was identified at Baseline ('predefined skin area'). Within the predefined LS areas, 3 closely adjacent non-overlapping spots were identified for subsequent SBF assessment. TEWL was measured prior to STS and after 5, 10, 15 and 20 STS on pre-defined LS areas at specified time points. STS assessment at Baseline (Week 0, Day 1) and Week 16 was conducted on the first spot. Percent Change from Baseline at Week 16 in TEWL after 5 STS on LS (first spot) in AD participants were reported in this outcome measure (OM).
次要结局
- Percent Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Percent Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16(Baseline, Week 16)
- Absolute Change From Baseline in TEWL After 20 STS on Non-lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Absolute Change From Baseline in TEWL After 20 STS on Lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Absolute Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16(Baseline, Week 16)
- Percent Change From Baseline in TEWL After 20 STS on Normal Skin in Healthy Volunteers at Week 16(Baseline, Week 16)
- Percent Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Percent Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Percent Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Percent Change From Baseline in TEWL After 20 STS on Non-lesional Skin (Non-LS) in AD Participants at Week 16(Baseline, Week 16)
- Absolute Change From Baseline in TEWL After 15 STS on Lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Absolute Change From Baseline in TEWL After 15 STS on Non-lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Absolute Change From Baseline in TEWL After 15 STS on Normal Skin in Healthy Volunteers at Week 16(Baseline, Week 16)
- Absolute Change From Baseline in TEWL After 10 STS on Lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Absolute Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Percent Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16(Baseline, Week 16)
- Absolute Change From Baseline in AUC of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)
- Percent Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Percent Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16(Baseline, Week 16)
- Absolute Change From Baseline in TEWL After 10 STS on Normal Skin in Healthy Volunteers at Week 16(Baseline, Week 16)
- Percent Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197(Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197)
- Percent Change From Baseline in Area Under the Curve (AUC) of TEWL on Lesional Skin in AD Participants at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)
- Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)
- Absolute Change From Baseline in TEWL After 10 STS on Non-lesional Skin in AD Participants at Week 16(Baseline, Week 16)
- Percent Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197(Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197)
- Percent Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)
- Absolute Change From Baseline in AUC of TEWL on Non-lesional Skin in AD Participants at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)
- Absolute Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)
- Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Lesional Skin in AD Participants at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)
- Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)
- Absolute Change From Baseline in TEWL After 5 STS on Normal Skin in Healthy Volunteers at Week 16(Baseline, Week 16)
- Percent Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197(Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197)
- Absolute Change From Baseline in TEWL Before STS on Lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197(Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197)
- Absolute Change From Baseline in TEWL Before STS on Non-lesional Skin in AD Participants at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197(Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197)
- Absolute Change From Baseline in TEWL Before STS on Normal Skin in Healthy Volunteers at Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197(Baseline, Days 8, 15, 22, 29, 43, 57, 85, 113, 155 and 197)
- Percent Change From Baseline in TEWL After 5 STS on Non-lesional Skin in AD Participants at Week16(Baseline, Week 16)
- Secondary: Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)
- Percent Change From Baseline in AUC of TEWL on Normal Skin in Healthy Volunteers at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)
- Percent Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Non-lesional Skin in AD Participants at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)
- Absolute Change From Baseline in TEWL After 5, 10, 15 and 20 STS on Normal Skin in Healthy Volunteers at Days 57, 113 and 197(Baseline, Days 57, 113 and 197)