Recruiting

Dupilumab

Sponsor:

Northwestern University

Code:

NCT05042258

Conditions

Atopic Dermatitis

Sleep Disturbance

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Dupilumab

Study Details

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

Conditions

Atopic Dermatitis

Sleep Disturbance

Study ID

NCT05042258

Start date

Aug 12, 2024

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dupilumab administration

dupilumab administered in weight based dosage for 12 weeks. The drug will be administered once a week during this time through a subcutaneous injection.

Interventions

Dupilumab

12 week dupilumab administration

Primary outcome measure

  • PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score [ Time Frame: 12 weeks ]
  • PROMIS patient score [ Time Frame: 12 weeks ]
  • Wake After Sleep Onset [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Dermatology CTU

312-227-6817eczemasleepstudy@northwestern.edu

Locations

Lurie Children's Hospital/Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

More Information

Sponsor

Northwestern University

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-04-27.