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.
Age range
6 Months – 17 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score
Timeframe: Baseline, Weeks 4, 16 and 52
Children and Adolescents: Percentage (%) of participants with EASI-50
Timeframe: Weeks 4, 16, 52
Children and Adolescents: Percentage (%) of participants with EASI-75
Timeframe: Weeks 4, 16, 52
Children and Adolescents: Percentage (%) of participants with EASI-90
Timeframe: Weeks 4, 16, 52
Children and Adolescents: Change from baseline in Patient Oriented Eczema Measure (POEM) score
Timeframe: Baseline, Weeks 4, 16, 52
Children and Adolescents: Percentage (%) of children (6-11 years) and adolescents with a ≥ 6-point improvement from baseline in POEM score
Timeframe: Baseline, Weeks 4, 16, 52
Children and Adolescents: Percentage of Infants (6 months-5 years) with a ≥ 3-point Improvement From Baseline in POEM score
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Timeframe: Baseline, Weeks 4, 6 and 52
Children and Adolescents: Percentage (%) of participants with adverse events
Timeframe: Baseline to Week 52
Children only: Mean Absolute Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score
Timeframe: Baseline, Weeks 4,6 and 52
Children only: Percentage Change from Baseline in SCORAD
Timeframe: Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) at 4, 16, 52 weeks
Timeframe: Baseline, Weeks 4, 16 and 52
Adolescents: Participant assessment: Percentage (%) of participants with a ≥4-point improvement from baseline in PP-NRS at 4, 16, 52 weeks
Timeframe: Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) of participants with a PP-NRS score of 0, 1 to 3, and 4 to 6 at 4, 16, 52 weeks (only patients with baseline PP-NRS ≥ 7
Timeframe: Weeks 4, 16 and 52
Children: Absolute Change from Baseline in SCORAD itch VAS
Timeframe: Baseline, Weeks 4, 16 and 52
Children: Percentage of Patients with Mild or no Itch (SCORAD itch VAS < 4)
Timeframe: Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Sleep Disturbance Numerical Rating Scale (SD-NRS) at 4, 16, 52 weeks
Timeframe: Baseline, Weeks 4, 16 and 52
Children: Mean Absolute Change from Baseline in SCORAD sleep VAS
Timeframe: Baseline, Weeks 4, 16, and 52
Children: Percentage Change from Baseline in SCORAD Sleep VAS
Timeframe: Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Children's Dermatology Life Quality Index (CDLQI) at 4, 16, 52 weeks
Timeframe: Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) of participants who achieve a ≥6-point reduction from baseline in CDLQI score at 4, 16, 52 weeks
Timeframe: Baseline, Weeks 4, 16 and 52
Adolescents: Percentage of Participants with cDLQI Score of 0-1
Timeframe: Weeks 4, 16 and 52
Adolescents: Percentage (%) of Participants with CDLQI Score of < 6 at 4, 16, 52 weeks (only patients with CDLQI ≥ 10 at baseline)
Timeframe: Weeks 4, 16 and 52
Children: Mean Absolute Change from Baseline cDLQI / Infants' Dermatitis Quality of Life Index (iDQoL) (for patients ˂ 4 years of age)
Timeframe: Weeks 4, 16 and 52
Children: Percentage of Participants who Achieve a ≥ 6-point Reduction from Baseline in cDLQI / iDQoL (for patients ˂ 4 years of age)
Timeframe: Weeks 4, 16 and 52
Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) Score of 0-1
Timeframe: Weeks 4, 16 and 52
Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) score < 6
Timeframe: Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Hospital Anxiety and Depression Scale (HADS) at 4, 16, 52 weeks
Timeframe: Baseline, Weeks 4, 16 and 52
Children: Percentage (%) Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) score
Timeframe: Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline Atopic Dermatitis Control Tool (ADCT) score at 4, 16, 52 weeks
Timeframe: Baseline, Weeks 4, 16 and 52
Adolescents: Participant assessment: Percentage (%) of participants with ADCT < 7 at 4, 16, 52 weeks
Timeframe: Weeks 4, 16 and 52
Children and Adolescents: Percentage (%) change from baseline the Dermatitis Family Impact (DFI) questionnaire at 4, 16, 52 weeks
Timeframe: Baseline, Weeks 4, 16 and 52
Children and Adolescents: Percentage (%) of Participants with Physician's Global Assessment (PGA) Face 0 or (/) 1, PGA Feet 0/1, PGA Hands 0/1, PGA Genitals 0/1 and at least a 2-point Improvement from Baseline
Timeframe: Baseline, Weeks 4, 16 and 52
Adolescents: Percentage (%) of Participants with PGA Genitals 0/1 and at least a 2-point Improvement from Baseline
Timeframe: Baseline, Weeks 4, 16 and 52
Children and Adolescents: Time to Discontinuation and Reasons for Discontinuation
Timeframe: Baseline up to Week 52
Mean Time to First TCS/TCI Discontinuation.
Timeframe: Baseline up to Week 52
Children: Percentage of Patients that Discontinue Topical Corticosteroids (TCS) and Topical Calcineurin Inhibitors (TCI)
Timeframe: Baseline, Weeks 4, 16 and 52
Adolescents: Participant assessment: Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM-9) score at 4, 16, 52 weeks
Timeframe: Weeks 4, 16 and 52
Adolescents: Percentage (%) change from baseline in Asthma Control Questionnaire (ACQ-6) at 4, 16, 52 weeks in participants with concomitant asthma
Timeframe: Baseline, Weeks 4, 16 and 52
Children: Mean Absolute Change from Baseline in Pediatric Asthma Questionnaire (PAQ)
Timeframe: Weeks 4, 16 and 52
Children: Percentage Change from Baseline in Pediatric Asthma Questionnaire (PAQ)
Timeframe: Weeks 4, 16 and 52
Children and Adolescents: Percentage (%) change from baseline in Total Nasal Symptoms Score (TNSS) at 4, 16, 52 weeks in participants with concomitant chronic rhinitis
Timeframe: Baseline, Weeks 4, 16 and 52