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

April 22, 2026 updated by: Amy Paller, Northwestern University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Efficiency in the Clinical Sleep Lab
Time Frame: 12 weeks
Change from baseline to Week 12 in percent Sleep Efficiency on PSG.
12 weeks
Sleep Onset Latency in the Clinical Sleep Lab
Time Frame: 12 weeks
Change from baseline to Week 12 in Sleep Onset Latency in minutes on PSG.
12 weeks
Total Sleep Time in the Clinical Sleep Lab
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Change from baseline to Week 12 in periodic limb movement frequency on PSG
12 weeks
Slow Wave Sleep Time in the Clinical Sleep Lab
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Change from baseline to Week 12 in % of time spent in REM sleep.
12 weeks
Wake After Sleep Onset (WASO) at Home
Time Frame: 12 weeks
Change from baseline to Week 12 in minutes of WASO averaged over 1-week of outpatient actigraphy.
12 weeks
Sleep Efficiency at Home
Time Frame: 12 weeks
Change from baseline to Week 12 in percent Sleep Efficiency on actigraphy.
12 weeks
Sleep Onset Latency at Home
Time Frame: 12 weeks
Change from baseline to Week 12 in Sleep Onset Latency in minutes on actigraphy.
12 weeks
Total Sleep Time at Home
Time Frame: 12 weeks
Change from baseline to Week 12 in Total Sleep Time in minutes on actigraphy.
12 weeks
Sleep Disturbance
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Percent change from baseline in weekly PROMIS sleep assessments at Weeks 1-12.
12 weeks
PROMIS Itch Severity
Time Frame: 12 weeks
Percent change from baseline to Week 12 in PROMIS parent-proxy and patient-reported itch severity Numeric Rating Scale (NRS).
12 weeks
Itch NRS
Time Frame: 12 weeks
Percent change from baseline in weekly Itch NRS at Weeks 1-12.
12 weeks
PROMIS Itch Intensity
Time Frame: 12 weeks
Percent change from baseline to Week 12 in PROMIS parent-proxy and patient-reported itch intensity and impact assessment (PIQ-C).
12 weeks
Scratch
Time Frame: 12 weeks
  1. Percent change from baseline to Week 12 in total minutes spent scratching during polysomnography (PSG).
  2. Percent change from baseline to Week 12 in number of scratching bouts during polysomnography.
12 weeks
Eczema Area and Severity Index (EASI)
Time Frame: 12 weeks

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)
Time Frame: 12 weeks
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)
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Change from baseline to Week 12 in Children's Dermatology Life Quality Index (CDLQI).
12 weeks
PROMIS Pediatric Profile
Time Frame: 12 weeks
Change from baseline to Week 12 in PROMIS Pediatric Profile measure (general QOL).
12 weeks
Inattention Score
Time Frame: 12 weeks
Change from baseline to Week 12 in Inattention Score.
12 weeks
Amplitude of Skin Barrier Hydration
Time Frame: 12 weeks
Change from baseline to Week 12 in the amplitude of skin barrier hydration during 24 hours of monitoring.
12 weeks
Peripheral Skin Temperature
Time Frame: 12 weeks
Change from baseline to Week 12 in the peripheral skin temperature during 24 hours of monitoring.
12 weeks
Amplitude of Melatonin
Time Frame: 12 weeks
Change from baseline to Week 12 in the amplitude of melatonin.
12 weeks
Transepidermal Water Loss
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Quantify CD4+CLA+ and CD8+CLA+ transcriptome changes from baseline to Week 12 (blood transcriptome).
12 weeks
Skin-Homing T-Cells
Time Frame: 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amy Paller, MD, Lurie Children's Hospital/Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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