Dupilumab for Moderate/Severe Atopic Dermatitis in Kids
Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
Recruiting
Phase 4Interventional Study
Atopic DermatitisSleep Disturbance
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 – 17
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Northwestern University · Other
Who this trial is looking for
This trial is looking for children ages 6 to 17 with moderate to severe atopic dermatitis that is not well controlled with standard treatments. Participants will receive dupilumab for 12 weeks and be monitored for improvements in sleep and skin itching.
Are You a Good Fit for This Trial?
Must be takingInhaled corticosteroidsTopical steroidsAntihistamines
You may be able to join if
I am between 6 and 17 years old.
I have moderate to severe atopic dermatitis.
I have a vIGA score of 3 or 4.
My sleep disturbance T-score is 60 or higher.
I can attend all study visits and follow procedures.
I have been using my current asthma and allergy medications regularly for 14 days before enrollment.
You may not be able to join if
I have poorly controlled asthma.
I have sleep problems at least twice in the last week due to allergies.
I take medication that causes scratching.
I have a serious medical condition like cancer.
I have sleep issues like sleep apnea or severe depression.
I have used topical steroids within the last week.
I cannot communicate in English.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
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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 Vali…
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).
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