Dupilumab Study for Sleep and Itch in Children With Atopic Dermatitis
Tests dupilumab in children with moderate or severe atopic dermatitis who have sleep problems.
Plain-language title generated from the registry record
Registry title: Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
Key facts
- Where
- Chicago, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT05042258, who can take part
Where in United States
- Lurie Children's Hospital/Northwestern UniversityChicago, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Northwestern University
- Trial code
- NCT05042258
- Record updated
- 27 April 2026
- Original description
Single center, prospective, Open label study of sleep, pruritus and circadian function pre/post 12-weeks of dupilumab treatment in children 6-17 years oldRead full original descriptionShow less
Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
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
Inclusion: 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 ≥60; 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.
Exclusion: Use of concomitant medication that causes scratching; Having applied topical steroids within 7 days of first or second PSG (important for biomarkers assessment); Other contraindication to receiving dupilumab (such as history of allergic reaction to dupilumab or any of its components); Self-reported sleep disturbance on 2 or more nights in the past 7 days due to allergic rhinitis; 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); Poorly controlled asthma (Asthma Control Test ≤19); 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); Pregnancy; Clinical blindness (circadian disturbing).