Improving sleep and skin symptoms in children with eczema using Dupilumab
Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
This study is testing if the medication Dupilumab can help improve sleep and skin symptoms in children aged 6 to 17 with moderate to severe eczema.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | dupilumab |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05042258 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-17 with moderate to severe atopic dermatitis that is not well controlled by topical treatments.
Not a fit: Patients with poorly controlled asthma or those experiencing sleep disturbances due to other allergic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and reduce itchiness in children suffering from atopic dermatitis.
How similar studies have performed: Other studies have shown promising results with Dupilumab in treating atopic dermatitis, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Chicago, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.