Can a shot help kids with eczema sleep through the night?
NCT ID NCT05042258
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether dupilumab (Dupixent) can improve sleep and reduce itching in 40 children aged 6-17 with moderate to severe eczema. Participants receive dupilumab for 12 weeks, and researchers measure sleep quality and itch using questionnaires and overnight sleep tests. The goal is to see if treating the skin condition also helps kids sleep better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dupilumab (Dupixent)
- What this could lead to
- If successful, this could show that dupilumab helps children with eczema sleep better and itch less, improving their daily life.
- What could go wrong
- This is a small, early-phase study with no placebo group, so results may not be definitive. It also only looks at short-term effects over 12 weeks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Lurie Children's Hospital/Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a daily liquid medicine calm severe eczema in toddlers and preschoolers?
- Scientists probe whether lebrikizumab rewires diseased skin at the molecular level
- Can a sensor under the mattress match a sleep lab?
- Can a Lab-Made antibody calm severe eczema?