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

NCT05042258 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2021-4161
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Atopic Dermatitis; Sleep Disturbance

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Dupilumab administration

EXPERIMENTAL

dupilumab administered in weight based dosage for 12 weeks. The drug will be administered once a week during this time through a subcutaneous injection.

Drug: Dupilumab

Interventions

Dupilumab DRUG

12 week dupilumab administration

Also known as: Dupixent

Dupilumab administration

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You 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 may not qualify 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).

Sponsors & Collaborators

• Northwestern University: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Lurie Children's Hospital/Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Parasomnias

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Amy Paller, MD

  Lurie Children's Hospital/Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dermatology CTU

CONTACT

312-227-6817; eczemasleepstudy@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: September 13, 2021
• Study Start: August 12, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)