Actively Recruiting

Phase 4
Age: 6Years - 17Years
All Genders
NCT05042258

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

Led by Northwestern University · Updated on 2026-04-27

40

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

R

Regeneron Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 6 and 17 years at enrollment
  • Moderate to severe chronic atopic dermatitis diagnosed by a pediatric dermatologist or allergist
  • Atopic dermatitis severity score of moderate (3) or severe (4) at baseline
  • PROMIS sleep disturbance T-score of 60 or higher (patient or parent-proxy for under 8 years old)
  • Willingness and ability to comply with visits and procedures
  • Stable use of inhaled corticosteroids, topical steroids, and antihistamines for at least 14 days before study start
Not Eligible

You will not qualify if you...

  • Poorly controlled asthma (Asthma Control Test score 19 or less)
  • Sleep disturbance on 2 or more nights in the past week due to allergic rhinitis
  • Use of medications that cause scratching
  • Major medical conditions such as cancer
  • Active sleep-affecting conditions like obstructive sleep apnea, restless leg syndrome, insomnia, narcolepsy, severe sleep disordered breathing, severe depression, COVID-19, or hives
  • Applied topical steroids within 7 days before either sleep study visit
  • Use of systemic immunosuppressants within 30 days before first sleep study
  • Showered or used moisturizers within 12 hours before either sleep study visit
  • Inability to communicate in English
  • Contraindications to dupilumab including history of allergic reaction to it or its components
  • Pregnancy
  • Clinical blindness affecting circadian rhythm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Lurie Children's Hospital/Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

D

Dermatology CTU

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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