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

Last updated: April 12, 2024
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dermatitis, Atopic

Allergy

Rash

Treatment

Dupilumab

Clinical Study ID

NCT06192563
OBS18015
U1111-1290-5921
  • Ages 12-17
  • All Genders

Study 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 Criteria

Inclusion

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 delFarmaco (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 representativeconsent and patient assent where applicable

Exclusion

Exclusion Criteria:

  • Prior use of dupilumab within 6 months prior the study entry
  • Patients currently participating in any interventional clinical trial which modifiespatient care
  • Any condition that, in the opinion of the Investigator, may interfere with patient'sability to participate in the study (e.g., substance abuse) The above information is not intended to contain all considerations relevant to a potentialparticipation in a clinical trial.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Dupilumab
Phase:
Study Start date:
November 30, 2023
Estimated Completion Date:
January 31, 2026

Study Description

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

Connect with a study center

  • Investigational Site Number: 002

    Bologna, 40138
    Italy

    Active - Recruiting

  • Investigational Site Number: 006

    Brescia, 25123
    Italy

    Active - Recruiting

  • Investigational Site Number: 004

    Firenze, 50139
    Italy

    Active - Recruiting

  • Investigational Site Number: 001

    Milano, 20122
    Italy

    Active - Recruiting

  • Investigational Site Number : 010

    Napoli, 80131
    Italy

    Active - Recruiting

  • Investigational Site Number: 010

    Napoli, 80131
    Italy

    Active - Recruiting

  • Investigational Site Number: 011

    Napoli, 80138
    Italy

    Active - Recruiting

  • Investigational Site Number: 005

    Roma, 00133
    Italy

    Active - Recruiting

  • Investigational Site Number: 009

    Roma, 00168
    Italy

    Active - Recruiting

  • Investigational Site Number: 014

    Verona, 37134
    Italy

    Active - Recruiting

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