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

Last updated: March 6, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atopic Dermatitis

Allergies & Asthma

Eczema (Atopic Dermatitis - Pediatric)

Treatment

Dupilumab

Clinical Study ID

NCT06415175
OBS18427
U1111-1306-7579
  • Ages 6-11
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Male or female aged 6 months to 11 years old at baseline.

  • Patients with severe Atopic dermatitis (AD) according to the investigator'sassessment.

  • Patients initiating dupilumab (in those patients initiated retrospectively 2 monthsbefore the start of the study, the baseline information must be correctly filled outin the medical records).

  • Signed informed consent by the parent/legally acceptable representative and assentby the patient appropriate to the patient's age.

Exclusion

Exclusion Criteria:

  • Patients who are participating in an interventional clinical trial that modifiespatient care.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Dupilumab
Phase:
Study Start date:
November 14, 2024
Estimated Completion Date:
November 23, 2027

Connect with a study center

  • Investigational Site Number : 7240005

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240006

    Esplugues de Llobregat, Catalunya [Cataluña] 08950
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240004

    Santiago de Compostela, Galicia [Galicia] 15706
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240010

    Madrid, Madrid, Comunidad De 28009
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240008

    Seville, Sevilla 41013
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240002

    Alicante, 03010
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240003

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240001

    Madrid, 28007
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240007

    Madrid, 28031
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240012

    Palma, 07120
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240012

    Palma de Mallorca, 07120
    Spain

    Site Not Available

  • Investigational Site Number : 7240016

    Valencia, 46026
    Spain

    Active - Recruiting

  • Investigational Site Number : 7240011

    Zaragoza, 50009
    Spain

    Active - Recruiting

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