Atopic DermatitisSleepChildren's healthDrugPhase 4
What this study is
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
What's being tested
- Dupilumab
Intervention · DRUG
12 week dupilumab administration
Study details
- Sponsor
- Northwestern University
- Conditions
- Atopic Dermatitis · Sleep Disturbance
- Enrolling
- 40 people
- Starts
- 2024-08-12
- Est. completion
- 2027-06
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openLurie Children's Hospital/Northwestern University
Chicago, Illinois, United States
Recruiting
Study team
Sponsor
Northwestern University
Study ID 2021-4161
Principal investigator
Amy Paller, MD
Lurie Children's Hospital/Northwestern University
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.