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Dupilumab · AD-BEASCUITS

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

Ensayo de Sanofi en Dermatitis atopica.

Más ensayos de: Dermatitis atópica.

Fase

no aplica

Estado

Reclutando pacientes

Participantes

230

previstos

Centros

9

Fin del objetivo primario

mar 2028

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en nov 2023.

Qué mide

Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score (Baseline, Weeks 4, 16 and 52) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroIn 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.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06192563), actualizada en ago 2026.