Observational study of dupilumab treatment in children with atopic dermatitis in Spain

Prospective, Observational, Longitudinal Study in Paediatric Patients With AD, Treated With Dupilumab in Spain

This study looks at how well dupilumab works and how it's used in children aged 6 months to 11 years with severe eczema in Spain over two years.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 6 Months to 11 Years
• Sex: All
• Sponsor: Sanofi (Industry-sponsored)
• Drugs / interventions: dupilumab
• Locations: 14 sites (Santiago de Compostela, A Coruña [La Coruña] and 13 other locations)
• Trial ID: NCT06415175 on ClinicalTrials.gov

What this trial studies

This multicentre, prospective, non-interventional study focuses on pediatric patients aged 6 months to 11 years with severe atopic dermatitis in Spain. It aims to document treatment patterns, patient characteristics, disease characteristics, and prior treatments, while also assessing the real-world effectiveness and safety of dupilumab over a two-year follow-up period. The study will not involve any diagnostic or therapeutic interventions outside of routine clinical practice.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 months to 11 years with severe atopic dermatitis who are initiating treatment with dupilumab.

Not a fit: Patients currently participating in an interventional clinical trial that modifies their care will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of dupilumab for treating severe atopic dermatitis in young patients.

How similar studies have performed: Other studies have shown success with dupilumab in treating atopic dermatitis, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

* Male or female aged 6 months to 11 years old at baseline.
* Patients with severe Atopic dermatitis (AD) according to the investigator's assessment.
* Patients initiating dupilumab (in those patients initiated retrospectively 2 months before the start of the study, the baseline information must be correctly filled out in the medical records).
* Signed informed consent by the parent/legally acceptable representative and assent by the patient appropriate to the patient's age.

Exclusion Criteria:

* Patients who are participating in an interventional clinical trial that modifies patient care.

Where this trial is running

Santiago de Compostela, A Coruña [La Coruña] and 13 other locations

• Investigational Site Number : 7240004 — Santiago de Compostela, A Coruña [La Coruña], Spain (Recruiting)
• Investigational Site Number : 7240005 — Oviedo, Asturias, Spain (Recruiting)
• Investigational Site Number : 7240006 — Esplugues de Llobregat, Barcelona [Barcelona], Spain (Recruiting)
• Investigational Site Number : 7240008 — Seville, Sevilla, Spain (Recruiting)
• Investigational Site Number : 7240002 — Alicante, Spain (Recruiting)
• Investigational Site Number : 7240003 — Barcelona, Spain (Recruiting)
• Investigational Site Number : 7240001 — Madrid, Spain (Recruiting)
• Investigational Site Number : 7240010 — Madrid, Spain (Recruiting)
• Investigational Site Number : 7240007 — Madrid, Spain (Recruiting)
• Investigational Site Number : 7240014 — Madrid, Spain (Recruiting)
• Investigational Site Number : 7240012 — Palma, Spain (Recruiting)
• Investigational Site Number : 7240009 — San Cristobal De La Laguna, Spain (Recruiting)
• Investigational Site Number : 7240016 — Valencia, Spain (Recruiting)
• Investigational Site Number : 7240011 — Zaragoza, Spain (Recruiting)

Study contacts

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

Conditions Atopic Dermatitis; Pediatric