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

NCT06415175 | Active Not Recruiting

• 2 other identifiers: OBS18427U1111-1306-7579
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Pediatric

Outcome Measures

Primary Outcomes (6)

• 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

  Including course of AD, recent AD treatment history, family history.

  At baseline

• Medical history of atopic comorbidities

  Selected atopic comorbidities over time will be reported.

  At baseline

• Medical history of non-atopic diseases

  At baseline

Secondary Outcomes (18)

• Description of real-world treatment patterns: Dupilumab dosage

  From baseline up to 24 months

• Description of real-world treatment patterns: Dupilumab frequency of administration

  From baseline up to 24 months

• Description of real-world treatment patterns: Dupilumab reason for discontinuation

  From baseline up to 24 months

• Description of real-world treatment patterns (other treatments): Other type of treatment

  From baseline up to 24 months

• Description of real-world treatment patterns (other treatments): Name of treatment

  From baseline up to 24 months

Study Arms (1)

Dupilumab

The information will be collected during consultation as part of the patient's usual follow-up.

Drug: Dupilumab

Interventions

Dupilumab DRUG

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

Dupilumab

Eligibility Criteria

• Age: 6 Months - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients aged 6 months to 11 years old at baseline and initiating Dupilumab for their Severe Atopic dermatitis (AD) in Spain.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (15)

Investigational Site Number : 7240004

Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

Location

Investigational Site Number : 7240006

Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

Location

Investigational Site Number : 7240005

Oviedo, Principality of Asturias, 33011, Spain

Location

Investigational Site Number : 7240008

Seville, Sevilla, 41013, Spain

Location

Investigational Site Number : 7240002

Alicante, 03010, Spain

Location

Investigational Site Number : 7240003

Barcelona, 08041, Spain

Location

Investigational Site Number : 7240001

Madrid, 28007, Spain

Location

Investigational Site Number : 7240010

Madrid, 28009, Spain

Location

Investigational Site Number : 7240007

Madrid, 28031, Spain

Location

Investigational Site Number : 7240014

Madrid, 28046, Spain

Location

Investigational Site Number : 7240013

Málaga, 29010, Spain

Location

Investigational Site Number : 7240012

Palma, 07120, Spain

Location

Investigational Site Number : 7240009

San Cristóbal de La Laguna, 38320, Spain

Location

Investigational Site Number : 7240016

Valencia, 46026, Spain

Location

Investigational Site Number : 7240011

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 23, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (15)