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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05042258
• Other study ID #: 2021-4161
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Dermatology CTU
• Phone: 312-227-6817
• Email: eczemasleepstudy[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

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).

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Dyssomnias
• Eczema
• Parasomnias
• Pruritus
• Sleep Disturbance

Intervention

Drug:
• Dupilumab
12 week dupilumab administration

Locations

Country	Name	City	State
United States	Lurie Children's Hospital/Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score	Improvement from baseline in PROMIS Parent-Proxy sleep disturbance score (short format 8-item) after 12 weeks post dupilumab initiation. The minimum value is "Never" and the maximum value is "Always". Higher scores mean worse outcomes.	12 weeks
Primary	PROMIS patient score	Improvement from baseline in PROMIS Patient-reported sleep disturbance score (short format 8-item) after 12 weeks post dupilumab initiation (in children = 8 years old). The minimum value is "Never" and the maximum value is "Always". Higher scores mean worse outcomes.	12 weeks
Primary	Wake After Sleep Onset	Percentage of patients achieving clinically significant improvement in minutes of Wake After Sleep Onset from baseline to Week 12 on inpatient polysomnography (PSG).	12 weeks