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Dupilumab for Atopic Dermatitis, Sleep, and Itching in Children

This study is looking at how a medication called dupilumab affects sleep, itching (pruritus), and the body's natural sleep-wake cycle (circadian function) in children aged 6 to 17 years old who have moderate to severe atopic dermatitis (eczema). Researchers want to see if dupilumab can improve these issues. Success will be measured by changes in parent and patient reports of symptoms, and how long children are awake after falling asleep, all assessed after 12 weeks of treatment. The study plans to enroll 40 participants, but its current recruitment status is unclear.

Study design
This is a single-center, open-label study, meaning both you and the study team will know you are receiving dupilumab. It will involve 40 participants.
What's involved
You would complete two overnight sleep studies, one before and one after using dupilumab for 12 weeks. These visits include sleep recordings (PSG), blood draws, skin sensors, urine collection, skin samples (tape stripping), and photographs.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at 12 weeks after starting dupilumab treatment.

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NCT05042258

Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis

Recruiting
PHASE4Ages 6–17InterventionalTreatment
Northwestern University
~40 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:Dupilumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score
Measured over 12 weeks
+2 more outcomes measured

Conditions

Atopic Dermatitis
Sleep Disturbance

Explore related trials

Atopic Dermatitis

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Amy Paller, MD · PRINCIPAL_INVESTIGATOR · Lurie Children's Hospital/Northwestern University

Who to contact

Dermatology CTU
[email protected]
312-227-6817
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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).

What this trial measures

  • PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score12 weeks

    Improvement from baseline in PROMIS Parent-Proxy sleep disturbance score (short format 8-item) after 12 weeks post dupilumab initiation. The minimum value is "Never" and the maximum value is "Always". Higher scores mean worse outcomes.

  • PROMIS patient score12 weeks

    Improvement from baseline in PROMIS Patient-reported sleep disturbance score (short format 8-item) after 12 weeks post dupilumab initiation (in children ≥ 8 years old). The minimum value is "Never" and the maximum value is "Always". Higher scores mean worse outcomes.

  • Wake After Sleep Onset12 weeks

    Percentage of patients achieving clinically significant improvement in minutes of Wake After Sleep Onset from baseline to Week 12 on inpatient polysomnography (PSG).