Clinical trial NCT05042258: Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
Official title: Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atopic Dermatitis
Sleep Disturbance
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2021-09-13
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Subjects will complete two overnight sleep studies, before and after using dupilumab for 12 weeks, to assess the effect of dupilumab on sleep disturbance in eczema patients. These overnight visits will include PSG, blood draws, skin sensors, urine collection, tape stripping, and photography. Subjects will be given dupilumab to use for 12 weeks at home before returning for the second sleep study.

Eligibility 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).

Primary outcomes:
measure: PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score
timeFrame: 12 weeks
measure: PROMIS patient score
timeFrame: 12 weeks
measure: Wake After Sleep Onset
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lurie Children's Hospital/Northwestern University
state: Illinois
Study officials:
affiliation: Lurie Children's Hospital/Northwestern University
name: Amy Paller, MD
role: PRINCIPAL_INVESTIGATOR
References: