Observing how adolescents with severe atopic dermatitis 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

This study looks at how well dupilumab treatment works for teenagers aged 12 to 17 with severe eczema over a year, focusing on their symptoms and quality of life.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Sanofi (Industry-sponsored)
• Drugs / interventions: dupilumab
• Locations: 9 sites (Bologna and 8 other locations)
• Trial ID: NCT06192563 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather data on adolescents aged 12 to 17 years with severe atopic dermatitis (AD) who have an Eczema Area and Severity Index (EASI) score of less than 16. The study will monitor the real-world effectiveness of dupilumab treatment over a 52-week period, focusing on patients who meet specific criteria for systemic therapy according to Italian reimbursement guidelines. By including participants with moderate to mild EASI scores, the study seeks to provide insights into the treatment's impact on quality of life and symptom relief in sensitive areas.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to 17 years with severe atopic dermatitis and an EASI score of less than 16 who meet specific treatment criteria.

Not a fit: Patients who have previously used dupilumab within the last 6 months or are currently involved in interventional clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the effectiveness of dupilumab for adolescents with less extensive skin lesions, potentially improving treatment options for this population.

How similar studies have performed: While there have been successful studies on dupilumab for severe atopic dermatitis, this specific approach focusing on adolescents with lower EASI scores is novel.

Eligibility criteria

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.

Where this trial is running

Bologna and 8 other locations

• Investigational Site Number: 002 — Bologna, Italy (Recruiting)
• Investigational Site Number: 006 — Brescia, Italy (Recruiting)
• Investigational Site Number: 004 — Firenze, Italy (Recruiting)
• Investigational Site Number: 001 — Milano, Italy (Recruiting)
• Investigational Site Number: 010 — Napoli, Italy (Recruiting)
• Investigational Site Number: 011 — Napoli, Italy (Recruiting)
• Investigational Site Number: 005 — Roma, Italy (Recruiting)
• Investigational Site Number: 009 — Roma, Italy (Recruiting)
• Investigational Site Number: 014 — Verona, Italy (Recruiting)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions Dermatitis Atopic