Trials / Recruiting
RecruitingNCT06192563
A Study to Observe How Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16) Respond to Dupilumab Treatment
A Prospective Observational Study of Adolescent Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16) Receiving Dupilumab
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
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 participants with moderate to mild EASI score and severe itching and/or localized AD are therefore necessary to better understand the potential clinical benefits of dupilumab in these populations. This is an Italian multicenter, 52-week observational (non-interventional) study which will collect data on the characteristics of adolescent (aged 12 to 17 years) participants who suffer from severe AD with EASI score less than (\<) 16, eligible for systemic dupilumab treatment according to Italian reimbursement criteria. It will study the real-world effectiveness and safety of dupilumab in this population, the effect of dupilumab on itching (pruritus), sleep, quality of life and related outcomes, localized AD in sensitive/visible areas, and on coexisting atopic conditions in adolescent participants who receive dupilumab for AD. It will also document dupilumab treatment satisfaction and dupilumab discontinuation in the study participants.
Detailed description
The individual observational period is planned to be up to 52 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dupilumab | Subcutaneous injection, standard of care as prescribed by treating physician (no investigational drug provided) |
Timeline
- Start date
- 2023-11-30
- Primary completion
- 2026-01-31
- Completion
- 2026-01-31
- First posted
- 2024-01-05
- Last updated
- 2024-04-15
Locations
9 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT06192563. Inclusion in this directory is not an endorsement.