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 (AD-BEASCUITS)

Sanofi

Status: Enrolling

Conditions: Dermatitis Atopic

Treatments: Drug: Dupilumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06192563

U1111-1290-5921 (Registry Identifier)

OBS18015

Details and patient eligibility

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 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.

Full description

The individual observational period is planned to be up to 52 weeks.

Enrollment: 150 estimated patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

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

3. 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

Exclusion criteria

• Prior use of dupilumab within 6 months prior the study entry
• Patients currently participating in any interventional clinical trial which modifies patient care
• Any condition that, in the opinion of the Investigator, may interfere with patient'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.

Trial design

150 participants in 1 patient group

Adolescents with AD

Description:

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.

Treatment:

Drug: Dupilumab