NCT05042258 Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
| NCT ID | NCT05042258 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Northwestern University |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-08-12 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2024-08-12 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 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).
Contact & Investigator
Amy Paller, MD
PRINCIPAL INVESTIGATOR
Lurie Children's Hospital/Northwestern University
Frequently Asked Questions
Who can join the NCT05042258 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05042258 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05042258 currently recruiting?
Yes, NCT05042258 is actively recruiting participants. Contact the research team at eczemasleepstudy@northwestern.edu for enrollment information.
Where is the NCT05042258 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05042258 clinical trial?
NCT05042258 is sponsored by Northwestern University. The principal investigator is Amy Paller, MD at Lurie Children's Hospital/Northwestern University. The trial plans to enroll 40 participants.
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