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

• Status: Recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborator: Northwestern University

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).