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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

Sponsor: Northwestern University · Participants: 40 · Started: Aug 12, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05042258

Locations in the U.S.

IllinoisLurie 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.