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

Sponsor
Sanofi
Study ID
NCT06192563
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Study Details

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.

Key Dates

First listed
Jan 5, 2024
Start date
Nov 30, 2023
Status verified
Aug 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
230 participants (estimated)

Arms

  • Arm: Pediatric patients with AD
    Pediatric participants (6 months to 17 years) who suffer from severe AD with EASI score \< 16 for adolescents (age 12-17 years) and \< 21 for children (6 months to 11 years), eligible for systemic dupilumab treatment according to Italian reimbursement criteria.

Primary Outcome Measure

Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score [ Time Frame: Baseline, Weeks 4, 16 and 52 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

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