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

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Disturbance; Atopic Dermatitis
• Intervention / Treatment: Drug: Dupilumab

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dermatology CTU; Phone Number: 312-227-6817; Email: eczemasleepstudy@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Lurie Children's Hospital/Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dupilumab administration; 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; 12 week dupilumab administration; Other Names: Dupixent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Efficiency in the Clinical Sleep Lab	Change from baseline to Week 12 in percent Sleep Efficiency on PSG.	12 weeks
Sleep Onset Latency in the Clinical Sleep Lab	Change from baseline to Week 12 in Sleep Onset Latency in minutes on PSG.	12 weeks
Total Sleep Time in the Clinical Sleep Lab	Change from baseline to Week 12 in Total Sleep Time in minutes on PSG.	12 weeks
Periodic Limb Movement Frequency in the Clinical Sleep Lab	Change from baseline to Week 12 in periodic limb movement frequency on PSG	12 weeks
Slow Wave Sleep Time in the Clinical Sleep Lab	Change from baseline to Week 12 in % of time spent in slow wave sleep (generally stage 3 sleep).	12 weeks
REM (Rapid Eye Movement) Sleep Time in the Clinical Sleep Lab	Change from baseline to Week 12 in % of time spent in REM sleep.	12 weeks
Wake After Sleep Onset (WASO) at Home	Change from baseline to Week 12 in minutes of WASO averaged over 1-week of outpatient actigraphy.	12 weeks
Sleep Efficiency at Home	Change from baseline to Week 12 in percent Sleep Efficiency on actigraphy.	12 weeks
Sleep Onset Latency at Home	Change from baseline to Week 12 in Sleep Onset Latency in minutes on actigraphy.	12 weeks
Total Sleep Time at Home	Change from baseline to Week 12 in Total Sleep Time in minutes on actigraphy.	12 weeks
Sleep Disturbance	Number of weeks it takes to achieve 5-point improvement from baseline in patient/parent-proxy reported sleep disturbance (assessed by weekly PROMIS sleep disturbance measures).	12 weeks
PROMIS Sleep Assessments	Percent change from baseline in weekly PROMIS sleep assessments at Weeks 1-12.	12 weeks
PROMIS Itch Severity	Percent change from baseline to Week 12 in PROMIS parent-proxy and patient-reported itch severity Numeric Rating Scale (NRS).	12 weeks
Itch NRS	Percent change from baseline in weekly Itch NRS at Weeks 1-12.	12 weeks
PROMIS Itch Intensity	Percent change from baseline to Week 12 in PROMIS parent-proxy and patient-reported itch intensity and impact assessment (PIQ-C).	12 weeks
Scratch	Percent change from baseline to Week 12 in total minutes spent scratching during polysomnography (PSG).; Percent change from baseline to Week 12 in number of scratching bouts during polysomnography.	12 weeks
Eczema Area and Severity Index (EASI)	Percent change from baseline to Week 12 in Eczema Area and Severity Index (EASI) Score. EASI score objectively measures disease severity. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with higher scores reflecting worse severity.	12 weeks
Eczema Area and Severity Index 75 (EASI-75)	Percent of patients with 75% or more improvement from baseline in Eczema Area and Severity Index (EASI-75)	12 weeks
Patient Oriented Eczema Measure (POEM)	Percent change from baseline to Week 12 in Patient Oriented Eczema Measure (POEM) by parent-proxy and children report (in patients ≥8yo).	12 weeks
Children's Dermatology Life Quality Index	Change from baseline to Week 12 in Children's Dermatology Life Quality Index (CDLQI).	12 weeks
PROMIS Pediatric Profile	Change from baseline to Week 12 in PROMIS Pediatric Profile measure (general QOL).	12 weeks
Inattention Score	Change from baseline to Week 12 in Inattention Score.	12 weeks
Amplitude of Skin Barrier Hydration	Change from baseline to Week 12 in the amplitude of skin barrier hydration during 24 hours of monitoring.	12 weeks
Peripheral Skin Temperature	Change from baseline to Week 12 in the peripheral skin temperature during 24 hours of monitoring.	12 weeks
Amplitude of Melatonin	Change from baseline to Week 12 in the amplitude of melatonin.	12 weeks
Transepidermal Water Loss	Change from baseline to Week 12 in the Transepidermal Water Loss (TEWL) during hourly monitoring while patients are awake.	12 weeks
CD4+CLA+ and CD8+CLA+ Transcriptome Changes	Quantify CD4+CLA+ and CD8+CLA+ transcriptome changes from baseline to Week 12 (blood transcriptome).	12 weeks
Skin-Homing T-Cells	Determine the presence of changes noted in skin-homing T-cells from baseline to Week 12 in the epidermal transcriptome (skin transcriptome).	12 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Regeneron Pharmaceuticals
• Investigators: Principal Investigator: Amy Paller, MD, Lurie Children's Hospital/Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Sleep Wake Disorders; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Parasomnias; Dermatitis, Atopic; dupilumab
• Other Study ID Numbers: 2021-4161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes