A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment
Recruiting · NCT06192563 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sanofi
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- Use of dupilumab within 6 months prior to study entry.
- Participants currently participating in any interventional clinical trial that modifies patient care.
- 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.
Where it is running
9 locations listed.
- Investigational Site Number: 002 - Bologna, Italy
- Investigational Site Number: 006 - Brescia, Italy
- Investigational Site Number: 004 - Florence, Italy
- Investigational Site Number: 001 - Milan, Italy
- Investigational Site Number: 010 - Naples, Italy
- Investigational Site Number: 011 - Naples, Italy
- Investigational Site Number: 005 - Roma, Italy
- Investigational Site Number: 009 - Roma, Italy
- Investigational Site Number: 014 - Verona, Italy