Observing how adolescents with severe atopic dermatitis respond to dupilumab treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, aged between 6 months and 17 years at the baseline visit.
* Patients with AD who have been prescribed dupilumab as per clinical practice (according to AIFA reimbursement policy) and who fulfill the following criteria:

  \-- Adolescents (12 to 17 years old) with EASI \< 16 and children (6 months to 11 years of age) with EASI \< 21 and.
  1. Children's Dermatology Life Quality Index (cDLQI)\* ≥ 10 and / or
  2. Itch NRS ≥ 7 and / or
  3. Localization in visible or sensitive areas (head/neck/hands or genitals)
* Participants/ caregivers able to understand and complete study-related questionnaires.
* Provided signed informed consent or parental/legally acceptable representative consent and participant assent where applicable.

  * Only for adolescents and children 6-11 years of age.

Exclusion Criteria:

* Use of dupilumab within 6 months prior to study entry.
* Participants currently participating in any interventional clinical trial that modifies patient care.
* Any condition that, in the opinion of the Investigator, may interfere with participant'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 it's running

• Investigational Site Number: 002
  Bologna, Italy Recruiting
• Investigational Site Number: 006
  Brescia, Italy Recruiting
• Investigational Site Number: 004
  Florence, Italy Recruiting
• Investigational Site Number: 001
  Milan, Italy Recruiting
• Investigational Site Number: 010
  Naples, Italy Recruiting
• Investigational Site Number: 011
  Naples, Italy Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• See if IBI3027 works as well as Dupilumab for moderate to severe atopic dermatitis

  This study tests whether IBI3027 can help people with moderate to severe atopic dermatitis as effectively as Dupilumab injections.

  Recruiting Phase 3 Innovent Biologics (Suzhou) Co. Ltd. · Guangzhou, Guangdong · NCT07754786

• Dupilumab's effect on anxiety and depression in moderate-to-severe atopic dermatitis

  This project will see if dupilumab reduces anxiety and depression in people with moderate-to-severe atopic dermatitis who are starting or recently started the medicine.

  Recruiting at 4 sites Sanofi · Doha and 6 other locations · NCT07467564

• Virtual reality game to reduce pain and anxiety during dupilumab injections

  This project will test whether a virtual reality game can reduce pain and anxiety for children aged 6–17 during dupilumab injections for moderate to severe atopic dermatitis.

  Recruiting at 2 sites St. Justine's Hospital · Montreal, Quebec and 1 other locations · NCT06182436

• Examining how dupilumab affects immune cells in atopic dermatitis

  This study is testing how the medication dupilumab affects immune cells in the skin of people with moderate to severe atopic dermatitis.

  Recruiting Phase 4 University of California, San Francisco · San Francisco, California · NCT05858619

• Using Dupixent and UVB therapy for treating atopic dermatitis

  This study is testing if combining a medication called Dupixent with UVB light therapy can help people with moderate to severe eczema feel better.

  Recruiting Phase 4 Psoriasis Treatment Center of Central New Jersey · East Windsor, New Jersey · NCT05285839

• Exploring how dupilumab works differently in various ethnic groups with atopic dermatitis

  This study is testing how well dupilumab works for people with atopic dermatitis from different ethnic backgrounds, like Caucasian, Asian, and African American, to see if their responses vary.

  Recruiting Phase 4 University of Michigan · Ann Arbor, Michigan · NCT05268107

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.