Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dupilumab.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis, Sleep Disturbance. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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.
Interventions
- Drug Dupilumab
12 week dupilumab administration
Primary outcome measures
- 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]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Lurie Children's Hospital/Northwestern University — Chicago
Identifiers
NCT: NCT05042258 · 2021-4161