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Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
RecruitingPhase 4
Who can join
Ages 6 to 17 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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).
About the study
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
What is being tested
- Dupilumab (drug)
Sponsor: Northwestern University · Participants: 40 · Started: Aug 12, 2024
Contact the study team
- Dermatology CTU · Phone: 312-227-6817
Official record on ClinicalTrials.gov — NCT05042258
Locations in the U.S.
| Illinois | Lurie Children's Hospital/Northwestern University, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.