Observes dupilumab use in children and teens with severe eczema and milder skin lesions
Observes dupilumab in children and teens with severe atopic dermatitis and limited skin lesions.
Plain-language title generated from the registry record
Registry title: A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment
Key facts
- Where
- Bologna, Brescia, Florence, Milan, Naples, Roma, and Verona, ItalySee the 9 sites
Where in Italy
- BolognaBologna, ItalyTaking people
- BresciaBrescia, ItalyTaking people
- FlorenceFlorence, ItalyTaking people
- MilanMilan, ItalyTaking people
- NaplesNaples, ItalyTaking people
- NaplesNaples, ItalyTaking people
- RomaRoma, ItalyTaking people
- RomaRoma, ItalyTaking people
- VeronaVerona, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sanofi
- Trial code
- NCT06192563
- Record updated
- 13 August 2026
- Original description
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.Read full original descriptionShow less
A Prospective Observational Study of Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16 for Adolescents and < 21 for Children) Receiving Dupilumab
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.
Inclusion: Male or female, aged between 6 months and 17 years at the baseline visit; Patients with AD who have been prescribed dupilumab as per clinical practice (according to AIFA reimbursement policy) and who fulfill the following criteria:; -- Adolescents (12 to 17 years old) with EASI < 16 and children (6 months to 11 years of age) with EASI < 21 and; Children's Dermatology Life Quality Index (cDLQI)* ≥ 10 and / or; Itch NRS ≥ 7 and / or; Localization in visible or sensitive areas (head/neck/hands or genitals); Participants/ caregivers able to understand and complete study-related questionnaires; Provided signed informed consent or parental/legally acceptable representative consent and participant assent where applicable; Only for adolescents and children 6-11 years of age.
Exclusion: Use of dupilumab within 6 months prior to study entry; Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study (e.g., substance abuse); The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial; Participants currently participating in any interventional clinical trial that modifies patient care.