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

NCT ID: NCT05042258

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-12
• Study Completion Date: 2025-12-31

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.

Conditions

Atopic Dermatitis; Sleep Disturbance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

12 week dupilumab administration

Interventions

Dupilumab

12 week dupilumab administration

Intervention Type: DRUG

Other Intervention Names

Dupixent

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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Amy Paller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Paller, MD

Role: PRINCIPAL_INVESTIGATOR

Lurie Children's Hospital/Northwestern University

Locations

Lurie Children's Hospital/Northwestern University

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dermatology CTU

Role: CONTACT

eczemasleepstudy@northwestern.edu

312-227-6817

Other Identifiers

2021-4161

Identifier Type: -

Identifier Source: org_study_id