NCT06192563Recruiting
A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 230 (estimated)
- First submitted
- 20 Dec 2023
- Start date
- 30 Nov 2023
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Sanofi
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06192563
What you commit to
- Study type: Observational
- Planned participants: 230
- From 30 Nov 2023 to the primary completion date, 31 Mar 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of dupilumab within 6 months prior to study entry.
Other illness
- 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.
Other
- Participants currently participating in any interventional clinical trial that modifies patient care.
Who the study is looking for
- 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.
Age in the registry: 6 months to 17 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigational Site Number: 002 Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Investigational Site Number: 006 Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Investigational Site Number: 004 Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Investigational Site Number: 001 Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Investigational Site Number: 011 Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Investigational Site Number: 010 Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Investigational Site Number: 005 Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Investigational Site Number: 009 Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Investigational Site Number: 014 Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.