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Clinical Trials in Spain / NCT06415175
Active, not recruiting Observational

Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain

NCT06415175 · tracked via the Priya Life Science Spain tracker
Sponsor
Sanofi
Phase
Observational
Started
2024-11-14
Last updated
2026-02-25

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

Dupilumab →

Dupilumab: This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.

Study summary

This is a multicentre, prospective, non-interventional study that aims to describe the treatment patterns of in Atopic dermatitis (AD) patients aged 6 months to 11 years old in Spain: patients' characteristics, disease characteristics, prior treatments for and treatment prescription modalities. As well as to document the real-world effectiveness and safety of dupilumab during the two years of follow up. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied.

Eligibility

Sex
ALL
Min age
6 Months
Max age
11 Years
Healthy volunteers
No
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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcome measure(s)

  • Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age — At baseline
  • Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Gender — At baseline
  • Characteristic of pediatric patients initiating treatment with dupilumab for Severe AD:Body mass index (BMI) — At baseline
  • Medical history characteristics of pediatric patients initiating treatment with dupilumab for Severe AD — At baseline
    Including course of AD, recent AD treatment history, family history.
  • Medical history of atopic comorbidities — At baseline
    Selected atopic comorbidities over time will be reported.
  • Medical history of non-atopic diseases — At baseline

Trial sites (15)

FacilityCityRegionStatus
Investigational Site Number : 7240004 Santiago de Compostela A Coruña [La Coruña]
Investigational Site Number : 7240006 Esplugues de Llobregat Barcelona [Barcelona]
Investigational Site Number : 7240005 Oviedo Principality of Asturias
Investigational Site Number : 7240008 Seville Sevilla
Investigational Site Number : 7240002 Alicante Spain
Investigational Site Number : 7240003 Barcelona Spain
Investigational Site Number : 7240001 Madrid Spain
Investigational Site Number : 7240010 Madrid Spain
Investigational Site Number : 7240007 Madrid Spain
Investigational Site Number : 7240014 Madrid Spain
Investigational Site Number : 7240013 Málaga Spain
Investigational Site Number : 7240012 Palma Spain
Investigational Site Number : 7240009 San Cristóbal de La Laguna Spain
Investigational Site Number : 7240016 Valencia Spain
Investigational Site Number : 7240011 Zaragoza Spain

On this site

📄 Dupixent (dupilumab) drug profile →

More Sanofi trials in Spain

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A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation Recruiting
A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes Recruiting
A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Recruiting
Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC) Recruiting

Other trials for the same condition

A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting
A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting
A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis Recruiting
A Study Evaluating APG777 in Atopic Dermatitis Active, not recruiting
A Long Term Extension Study to Evaluate the Safety and Efficacy of Afimkibart (RO7790121) in Participants With Atopic Dermatitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06415175 on ClinicalTrials.gov ↗ ← All trials in Spain