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

Eligibility

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).