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

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

Conditions

Atopic Dermatitis, Sleep Disturbance

Study Overview

Study Details

Study overview

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

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

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

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Chicago

Lurie Children's Hospital/Northwestern University, Chicago, Illinois, United States, 60611

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

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

Study Record Dates

2025-12