Clinical trial NCT06415175: Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain
Official title: Prospective, Observational, Longitudinal Study in Paediatric Patients With AD, Treated With Dupilumab in Spain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Keywords: Pediatric
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2024-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age
timeFrame: At baseline
measure: Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Gender
timeFrame: At baseline
measure: Characteristic of pediatric patients initiating treatment with dupilumab for Severe AD:Body mass index (BMI)
timeFrame: At baseline
measure: Medical history characteristics of pediatric patients initiating treatment with dupilumab for Severe AD
timeFrame: At baseline
measure: Medical history of atopic comorbidities
timeFrame: At baseline
measure: Medical history of non-atopic diseases
timeFrame: At baseline
Secondary outcomes:
measure: Description of real-world treatment patterns: Dupilumab dosage
timeFrame: From baseline up to 24 months
measure: Description of real-world treatment patterns: Dupilumab frequency of administration
timeFrame: From baseline up to 24 months
measure: Description of real-world treatment patterns: Dupilumab reason for discontinuation
timeFrame: From baseline up to 24 months
measure: Description of real-world treatment patterns (other treatments): Other type of treatment
timeFrame: From baseline up to 24 months
measure: Description of real-world treatment patterns (other treatments): Name of treatment
timeFrame: From baseline up to 24 months
measure: Description of real-world treatment patterns (other treatments): Duration of treatment
timeFrame: From baseline up to 24 months
measure: Description of real-world treatment patterns (other treatments): Reason for discontinuation (if applicable)
timeFrame: From baseline up to 24 months
measure: Participant-caregiver assessment: Change from baseline in the Children's Dermatology Life Quality Index score
timeFrame: From baseline up to 24 months
measure: Participant-caregiver assessment: Change from baseline in the Infant's Dermatology Life Quality Index score
timeFrame: From baseline up to 24 months
measure: Participant-caregiver assessment: Change from baseline in the Dermatitis Family Impact (DFI) questionnaire
timeFrame: From baseline up to 24 months
measure: Participant-caregiver assessment: Change from baseline in the patient's Worst Itch Numerical Rating Scale (WI-NRS)
timeFrame: From baseline up to 24 months
measure: Caregiver assessment: Change from baseline in the patient's Worst Itch Scale Numerical Rating Scale (WSI-NRS)
timeFrame: From baseline up to 24 months
measure: Physician assessment: Change from baseline in the eczema severity using the Eczema Area and Severity Index (EASI)
timeFrame: From baseline up to 24 months
measure: Physician assessment: Percent change from beseline in the Body Surface Area (BSA) (%) affected by AD
timeFrame: From baseline up to 24 months
measure: Physician assessment: Change in Proportion of patients with Validated Investigator's Global Assessment (IGA)
timeFrame: From baseline up to 24 months
measure: Physician assessment: Change from baseline in Biomarkers
timeFrame: From baseline up to 24 months
measure: Number of Adverse Events (AE) / Serious Adverse Events (SAE) / Adverse Event of Special Interest (AESI)
timeFrame: From date of signed ICF, up to 24 months
measure: Health Care Resource Utilization (HCRU) Questionnaire
timeFrame: From baseline up to 24 months
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Investigational Site Number : 7240004
state: A Coruña [La Coruña]
city: Oviedo
country: Spain
facility: Investigational Site Number : 7240005
state: Asturias
city: Esplugues de Llobregat
country: Spain
facility: Investigational Site Number : 7240006
state: Barcelona [Barcelona]
city: Seville
country: Spain
facility: Investigational Site Number : 7240008
state: Sevilla
city: Alicante
country: Spain
facility: Investigational Site Number : 7240002
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240003
city: Madrid
country: Spain
facility: Investigational Site Number : 7240001
city: Madrid
country: Spain
facility: Investigational Site Number : 7240010
city: Madrid
country: Spain
facility: Investigational Site Number : 7240007
city: Madrid
country: Spain
facility: Investigational Site Number : 7240014
city: Málaga
country: Spain
facility: Investigational Site Number : 7240013
city: Palma
country: Spain
facility: Investigational Site Number : 7240012
city: San Cristobal De La Laguna
country: Spain
facility: Investigational Site Number : 7240009
city: Valencia
country: Spain
facility: Investigational Site Number : 7240016
city: Zaragoza
country: Spain
facility: Investigational Site Number : 7240011
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: