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NCT Number: NCT06415175

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

6 month–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number : 7240004, Santiago de Compostela, A Coruña [La Coruña], Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dupilumab

Drug

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

Primary outcomes

  1. Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age

    Time frame: At baseline

  2. Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Gender

    Time frame: At baseline

  3. Characteristic of pediatric patients initiating treatment with dupilumab for Severe AD:Body mass index (BMI)

    Time frame: At baseline

  4. Medical history characteristics of pediatric patients initiating treatment with dupilumab for Severe AD

    Time frame: At baseline

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

  5. Medical history of atopic comorbidities

    Time frame: At baseline

    Selected atopic comorbidities over time will be reported.

  6. Medical history of non-atopic diseases

    Time frame: At baseline

Secondary outcomes

  1. Description of real-world treatment patterns: Dupilumab dosage

    Time frame: From baseline up to 24 months

  2. Description of real-world treatment patterns: Dupilumab frequency of administration

    Time frame: From baseline up to 24 months

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

    Time frame: From baseline up to 24 months

    Reason for discontinuation will be reported if applicable.

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

    Time frame: From baseline up to 24 months

    In case of receiving other treatments for AD, topical or systemic.

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

    Time frame: From baseline up to 24 months

    In case of receiving other treatments for AD, topical or systemic.

  6. Description of real-world treatment patterns (other treatments): Duration of treatment

    Time frame: From baseline up to 24 months

    In case of receiving other treatments for AD, topical or systemic.

  7. Description of real-world treatment patterns (other treatments): Reason for discontinuation (if applicable)

    Time frame: From baseline up to 24 months

    In case of receiving other treatments for AD, topical or systemic. Reason for discontinuation will be reported if applicable.

  8. Participant-caregiver assessment: Change from baseline in the Children's Dermatology Life Quality Index score

    Time frame: From baseline up to 24 months

    The Children's Dermatology Life Quality Index (cDLQI) it is a 10-item questionnaire that assesses six different aspects that may affect quality of life, including symptoms and feelings, daily activities, leisure, work and school performance, personal relationships, and treatment. Each of the 10 questions is scored from 0 (not at all) to 3 (very much) and the overall cDLQI is calculated by summing the score of each question, resulting in a total score between 0-30. The higher the score, the more quality of life is impaired.

  9. Participant-caregiver assessment: Change from baseline in the Infant's Dermatology Life Quality Index score

    Time frame: From baseline up to 24 months

    The Infant Dermatology Quality of Life Index (iDLQI) contains 10 questions and a response scale divided into four boxes. Each box gives a point between 0 and 3. The lower number is understood as the most positive for the participant.

    The index is filled out by a parent to a participating child between the ages of 0 to 5 years.

    Points from each question are added together and the end-sum represents the score. The sum score can be between 0 and 30. The higher the score the worse the assumed quality of life.

  10. Participant-caregiver assessment: Change from baseline in the Dermatitis Family Impact (DFI) questionnaire

    Time frame: From baseline up to 24 months

    The DFI is a 10-item disease specific questionnaire assessing the impact of having a child with AD on family Quality of Life (QoL). The DFI questions are scored ranging from 0 to 3, and the total DFI score ranges from 0 to 30. The time frame of reference is the past week, and a higher DFI score indicates greater impairment in family QoL as affected by AD.

  11. Participant-caregiver assessment: Change from baseline in the patient's Worst Itch Numerical Rating Scale (WI-NRS)

    Time frame: From baseline up to 24 months

    WI-NRS is a validated measure of itch severity. Patients will be asked daily to rate the intensity of their worst pruritus (itch) over the past 24 hours, using a 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate more severity.

  12. Caregiver assessment: Change from baseline in the patient's Worst Itch Scale Numerical Rating Scale (WSI-NRS)

    Time frame: From baseline up to 24 months

    The WSI-NRS is a single-item caregiver-reported. The caregivers describe their child "scratch" or "itch" in the AD-affected area by using numeric response options (0: no scratching/itching to 10: worst scratching/itching). Higher scores indicate more severity.

  13. Physician assessment: Change from baseline in the eczema severity using the Eczema Area and Severity Index (EASI)

    Time frame: From baseline up to 24 months

    The EASI is calculated by summing 4 separate scores of the (1) head/neck, (2) upper extremities, (3) trunk, and (4) lower extremities. For each of the 4 anatomical regions, the score formula is SxAxM ["S" is the congregate score from the severity of 4 signs: erythema, oedema/papulation, excoriation, and lichenification graded on a discrete scale from 0 to 3, where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe, giving S a maximum of 12. "A" represents the area to which AD affects the body, yielding a maximum of 6 points: 0 = 0%, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. "M" is a multiplier, which is 0.1, 0.2, 0.3, and 0.4, respectively, for the region affected in those ≥8 years and 0.2, 0.2, 0.3, and 0.3, respectively, for those <8 years. The final EASI score is calculated based on the sum of the scores from the 4 anatomical regions. A higher score means higher AD severity. Scores range from 0 (no disease) to 72 (maximal disease severity).

  14. Physician assessment: Percent change from beseline in the Body Surface Area (BSA) (%) affected by AD

    Time frame: From baseline up to 24 months

    BSA affected by AD disease will be assessed for each major section of the body (head, neck, anterior trunk, back, upper limbs, lower limbs, and genitals). It will be reported as a percentage of all major body sections combined.

  15. Physician assessment: Change in Proportion of patients with Validated Investigator's Global Assessment (IGA)

    Time frame: From baseline up to 24 months

    The IGA is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

  16. Physician assessment: Change from baseline in Biomarkers

    Time frame: From baseline up to 24 months

    Biomarker analysis will be performed, if available, in routine clinical practice and at routine visits

  17. Number of Adverse Events (AE) / Serious Adverse Events (SAE) / Adverse Event of Special Interest (AESI)

    Time frame: From date of signed ICF, up to 24 months

    The number of events and the percentage of patients who had at least one event will be described.

  18. Health Care Resource Utilization (HCRU) Questionnaire

    Time frame: From baseline up to 24 months

    Health care resource utilization may include hospitalizations (including length of stay), outpatient visits, urgent care or emergency room visits.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Acronym: PROADAP

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 16, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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