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

Primary Purpose

Atopic Dermatitis, Sleep Disturbance

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dupilumab
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Lurie Children's Hospital/Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dupilumab administration

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
July 27, 2021
Last Updated
October 1, 2023
Sponsor
Northwestern University
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05042258
Brief Title
Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
Official Title
Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Regeneron Pharmaceuticals

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dupilumab administration
Arm Type
Experimental
Arm Description
dupilumab administered in weight based dosage for 12 weeks. The drug will be administered once a week during this time through a subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Dupilumab
Other Intervention Name(s)
Dupixent
Intervention Description
12 week dupilumab administration
Primary Outcome Measure Information:
Title
PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score
Description
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.
Time Frame
12 weeks
Title
PROMIS patient score
Description
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.
Time Frame
12 weeks
Title
Wake After Sleep Onset
Description
Percentage of patients achieving clinically significant improvement in minutes of Wake After Sleep Onset from baseline to Week 12 on inpatient polysomnography (PSG).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dermatology CTU
Phone
312-227-6817
Email
eczemasleepstudy@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Paller, MD
Organizational Affiliation
Lurie Children's Hospital/Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lurie Children's Hospital/Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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