RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-08-12

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05042258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Study Contact

Dermatology CTU

CONTACT

312-227-6817

eczemasleepstudy@northwestern.edu

Principal Investigator

Amy Paller, MD

PRINCIPAL_INVESTIGATOR

Lurie Children's Hospital/Northwestern University

Study Locations (Sites)

Lurie Children's Hospital/Northwestern University

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Northwestern University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-12

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-08-12

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis
Sleep Disturbance