Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
Recruiting now · Phase 4
Conditions studied: Atopic Dermatitis, Sleep Disturbance
In brief
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
Key facts
- Study ID
- NCT05042258
- Run by
- Northwestern University
- People needed
- 40
- Starts
- 2024-08-12
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-04-27
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Lurie Children's Hospital/Northwestern University — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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