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
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• Male or female, aged between 12 and 17 years at the baseline visit

• Patients with AD who have been prescribed dupilumab according to Agenzia Italiana del Farmaco (AIFA) reimbursement criteria and fulfilling the following criteria:

• Patients with EASI\<16 and

⁃ Children's Dermatology Life Quality Index (CDLQI) ≥ 10 or

⁃ Peak Pruritus Numerical Rating Scale (PP-NRS) ≥ 7 or

⁃ localization in visible or sensitive areas (head/neck/hands or genitals)

∙ Patients able to understand and complete study-related questionnaires

‣ Provided signed informed consent or parental/legally acceptable representative consent and patient assent where applicable

Locations
Other Locations
Italy
Investigational Site Number: 002
RECRUITING
Bologna
Investigational Site Number: 006
RECRUITING
Brescia
Investigational Site Number: 004
RECRUITING
Florence
Investigational Site Number: 001
RECRUITING
Milan
Investigational Site Number: 010
RECRUITING
Napoli
Investigational Site Number: 011
RECRUITING
Napoli
Investigational Site Number: 005
RECRUITING
Roma
Investigational Site Number: 009
RECRUITING
Roma
Investigational Site Number: 014
RECRUITING
Verona
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 150
Treatments
Adolescents with AD
Adolescent (aged 12 to 17 years) participants who suffer from severe AD with EASI score \< 16, eligible for systemic dupilumab treatment according to Italian reimbursement criteria.
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov