Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Wake After Sleep Onset
研究概览
简要总结
Single center, prospective, Open label study of sleep, pruritus and circadian function pre/post 12-weeks of dupilumab treatment in children 6-17 years old
详细描述
Subjects will complete two overnight sleep studies, before and after using dupilumab for 12 weeks, to assess the effect of dupilumab on sleep disturbance in eczema patients. These overnight visits will include PSG, blood draws, skin sensors, urine collection, tape stripping, and photography. Subjects will be given dupilumab to use for 12 weeks at home before returning for the second sleep study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants, 6-17 years old at time of enrollment.
- •Moderate to severe chronic AD inadequately controlled by topical treatment, diagnosed according to Hanifin and Rajka criteria by a pediatric dermatologist or allergist.
- •AD severity will be determined at baseline with Validated Investigator Global Assessment (vIGA) score of moderate (3) or severe (4).
- •Patient assessed or parent-proxy (under 8 years old) PROMIS sleep disturbance T-score ≥
- •Willing and able to comply with visits and study-related procedures.
- •On stable regimens (consistent use 14 days before Day 1 of study enrollment) of inhaled corticosteroids, topical steroids, and antihistamines.
排除标准
- •Poorly controlled asthma (Asthma Control Test ≤19).
- •Self-reported sleep disturbance on 2 or more nights in the past 7 days due to allergic rhinitis.
- •Use of concomitant medication that causes scratching.
- •Major medical condition (such as cancer).
- •Active condition that could affect sleep, such as obstructive sleep apnea, restless leg syndrome, insomnia, narcolepsy, severe sleep disordered breathing, severe depression, COVID-19, or hives (urticaria).
- •Having applied topical steroids within 7 days of first or second PSG (important for biomarkers assessment).
- •Use of systemic immunosuppressant within 30 days of first PSG.
- •Having showered or used moisturizers within 12 hours of first or second PSG.
- •Unable to communicate in English (some PROMIS questionnaires not available in translation).
- •Other contraindication to receiving dupilumab (such as history of allergic reaction to dupilumab or any of its components).
- •Pregnancy.
- •Clinical blindness (circadian disturbing).
研究组 & 干预措施
Dupilumab administration
dupilumab administered in weight based dosage for 12 weeks. The drug will be administered once a week during this time through a subcutaneous injection.
干预措施: Dupilumab (Drug)
结局指标
主要结局
Wake After Sleep Onset
时间窗: 12 weeks
Percentage of patients achieving clinically significant improvement in minutes of Wake After Sleep Onset from baseline to Week 12 on inpatient polysomnography (PSG).
PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score
时间窗: 12 weeks
Improvement from baseline in PROMIS Parent-Proxy sleep disturbance score (short format 8-item) after 12 weeks post dupilumab initiation. The minimum value is "Never" and the maximum value is "Always". Higher scores mean worse outcomes.
PROMIS patient score
时间窗: 12 weeks
Improvement from baseline in PROMIS Patient-reported sleep disturbance score (short format 8-item) after 12 weeks post dupilumab initiation (in children ≥ 8 years old). The minimum value is "Never" and the maximum value is "Always". Higher scores mean worse outcomes.
次要结局
未报告次要终点
研究者
Amy Paller
Principal Investigator
Northwestern University