A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment

In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive/visible areas was not specifically evaluated. Further data about the effectiveness of dupilumab in adolescent and children participants with moderate to mild EASI score and severe itching and/or localized AD to better understand the potential clinical benefits of dupilumab in these populations. The main objective of the study us to assess the real-word effectiveness and safety of dupilumab in pediatric patients (age 6 months-17 years) who suffer from severe AD with EASI score \< 16 for adolescents (age 12-17 years) and \< 21 for children (age 6 months-11 years), and who are eligible for systemic therapy according to Italian reimbursement criteria.

NCT Number	NCT06192563
Lead Sponsor	Sanofi Collaborators: Regeneron Pharmaceuticals
Conditions	Atopic Dermatitis
Enrollment	230 participants
Start Date	2023-11-30
Primary Completion	2028-03-31 (estimated)
Study Completion	2028-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-13