Improving sleep and skin symptoms in children with eczema using Dupilumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of Dupilumab on sleep quality, skin itchiness, and circadian function in children aged 6 to 17 with moderate to severe atopic dermatitis. Participants will undergo two overnight sleep studies, one before and one after a 12-week treatment period with Dupilumab. The study will involve various assessments including polysomnography, blood draws, and skin evaluations to measure changes in sleep disturbances and eczema symptoms. The goal is to determine if Dupilumab can enhance sleep and overall quality of life for these patients.

Why it matters

Who can join: the full rules

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).

Where it's running

• Lurie Children's Hospital/Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Amy Paller, MD — Lurie Children's Hospital/Northwestern University
• Study coordinator: Dermatology CTU
• Email: eczemasleepstudy@northwestern.edu
• Phone: 312-227-6817

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study looks at how well dupilumab treatment works for teenagers aged 12 to 17 with severe eczema over a year, focusing on their symptoms and quality of life.

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• Examining how dupilumab affects immune cells in atopic dermatitis

  This study is testing how the medication dupilumab affects immune cells in the skin of people with moderate to severe atopic dermatitis.

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• Using Dupixent and UVB therapy for treating atopic dermatitis

  This study is testing if combining a medication called Dupixent with UVB light therapy can help people with moderate to severe eczema feel better.

  Recruiting Phase 4 Psoriasis Treatment Center of Central New Jersey · East Windsor, New Jersey · NCT05285839

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.