Atopic Dermatitis Clinical Trials

Find Atopic Dermatitis Clinical Trials Near You

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

Who is this study for? Children with moderate/severe atopic dermatitis
What treatments are being studied? Dupilumab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Lurie Children's Hospital/Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Dermatology CTU
eczemasleepstudy@northwestern.edu
312-227-6817
Time Frame
Start Date: 2024-08-12
Estimated Completion Date: 2025-12
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Northwestern University

This content was sourced from clinicaltrials.gov