Atopic DermatitisPROADAPNCT06415175
Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain
An observational study of Atopic Dermatitis, run by Sanofi at 15 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 11 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Dupilumab
- How many people
- 143 participants
- Where
- 15 sitesSpain
- Study dates
- 14 Nov 2024to 23 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged 6 months to 11 years old at baseline and initiating Dupilumab for their Severe Atopic dermatitis (AD) in Spain.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Investigational Site Number : 7240002
Alicante, 03010
Investigational Site Number : 7240003
Barcelona, 08041
Investigational Site Number : 7240006
Esplugues de Llobregat, Barcelona [Barcelona], 08950
Investigational Site Number : 7240001
Madrid, 28007
Investigational Site Number : 7240010
Madrid, 28009
Investigational Site Number : 7240007
Madrid, 28031
Investigational Site Number : 7240014
Madrid, 28046
Investigational Site Number : 7240013
Málaga, 29010
Investigational Site Number : 7240005
Oviedo, Principality of Asturias, 33011
Investigational Site Number : 7240012
Palma, 07120
Investigational Site Number : 7240009
San Cristóbal de La Laguna, 38320
Investigational Site Number : 7240004
Santiago de Compostela, A Coruña [La Coruña], 15706
Investigational Site Number : 7240008
Seville, Sevilla, 41013
Investigational Site Number : 7240016
Valencia, 46026
Investigational Site Number : 7240011
Zaragoza, 50009
About this study
Official title: Prospective, Observational, Longitudinal Study in Paediatric Patients With AD, 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Dupilumab
- Keywords
- Pediatric
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
This study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | The information will be collected during consultation as part of the patient's usual follow-up. Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age
Measured: At baseline
Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Gender
Measured: At baseline
Characteristic of pediatric patients initiating treatment with dupilumab for Severe AD:Body mass index (BMI)
Measured: 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.
Measured: At baseline
Medical history of atopic comorbidities
Selected atopic comorbidities over time will be reported.
Measured: At baseline
Medical history of non-atopic diseases
Measured: At baseline
Secondary outcomes (18)
Description of real-world treatment patterns: Dupilumab dosage
Measured: From baseline up to 24 months
Description of real-world treatment patterns: Dupilumab frequency of administration
Measured: From baseline up to 24 months
Description of real-world treatment patterns: Dupilumab reason for discontinuation
Reason for discontinuation will be reported if applicable.
Measured: From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Other type of treatment
In case of receiving other treatments for AD, topical or systemic.
Measured: From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Name of treatment
In case of receiving other treatments for AD, topical or systemic.
Measured: From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Duration of treatment
In case of receiving other treatments for AD, topical or systemic.
Measured: From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Reason for discontinuation (if applicable)
In case of receiving other treatments for AD, topical or systemic. Reason for discontinuation will be reported if applicable.
Measured: From baseline up to 24 months
Participant-caregiver assessment: Change from baseline in the Children's Dermatology Life Quality Index score
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.
Measured: From baseline up to 24 months
Participant-caregiver assessment: Change from baseline in the Infant's Dermatology Life Quality Index score
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.
Measured: From baseline up to 24 months
Participant-caregiver assessment: Change from baseline in the Dermatitis Family Impact (DFI) questionnaire
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.
Measured: From baseline up to 24 months
Participant-caregiver assessment: Change from baseline in the patient's Worst Itch Numerical Rating Scale (WI-NRS)
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.
Measured: From baseline up to 24 months
Caregiver assessment: Change from baseline in the patient's Worst Itch Scale Numerical Rating Scale (WSI-NRS)
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.
Measured: From baseline up to 24 months
Physician assessment: Change from baseline in the eczema severity using the Eczema Area and Severity Index (EASI)
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).
Measured: From baseline up to 24 months
Physician assessment: Percent change from beseline in the Body Surface Area (BSA) (%) affected by AD
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.
Measured: From baseline up to 24 months
Physician assessment: Change in Proportion of patients with Validated Investigator's Global Assessment (IGA)
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).
Measured: From baseline up to 24 months
Physician assessment: Change from baseline in Biomarkers
Biomarker analysis will be performed, if available, in routine clinical practice and at routine visits
Measured: From baseline up to 24 months
Number of Adverse Events (AE) / Serious Adverse Events (SAE) / Adverse Event of Special Interest (AESI)
The number of events and the percentage of patients who had at least one event will be described.
Measured: From date of signed ICF, up to 24 months
Health Care Resource Utilization (HCRU) Questionnaire
Health care resource utilization may include hospitalizations (including length of stay), outpatient visits, urgent care or emergency room visits.
Measured: From baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start14 Nov 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion23 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415175
- Sponsor's protocol ID
- OBS18427
- Other IDs
- U1111-1306-7579
- Acronym
- PROADAP
- Status last verified
- Feb 2026
- First submitted
- 10 May 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Longitudinal Study in Paediatric Patients With AD, Treated With Dupilumab in Spain
- ClinicalTrials.gov ID
- NCT06415175
- Acronym / sponsor ID
- PROADAP / OBS18427
- Conditions
- Atopic Dermatitis
- Keywords
- Pediatric
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 143 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 23 Nov 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | – | Drug: DupilumabThe information will be collected during consultation as part of the patient's usual follow-up. |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged 6 months to 11 years old at baseline and initiating Dupilumab for their Severe Atopic dermatitis (AD) in Spain.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabThis study will not administer any treatment, only observe the treatment as prescribed in real world-clinical practice. | Drug | Dupilumab |
Primary outcome
Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age
Time frame: At baseline
Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Gender
Time frame: At baseline
Characteristic of pediatric patients initiating treatment with dupilumab for Severe AD:Body mass index (BMI)
Time frame: At baseline
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.
Medical history of atopic comorbidities
Time frame: At baseline
Selected atopic comorbidities over time will be reported.
Medical history of non-atopic diseases
Time frame: At baseline
18 secondary outcomes
Description of real-world treatment patterns: Dupilumab dosage
Time frame: From baseline up to 24 months
Description of real-world treatment patterns: Dupilumab frequency of administration
Time frame: From baseline up to 24 months
Description of real-world treatment patterns: Dupilumab reason for discontinuation
Time frame: From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Other type of treatment
Time frame: From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Name of treatment
Time frame: From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Duration of treatment
Time frame: From baseline up to 24 months
Description of real-world treatment patterns (other treatments): Reason for discontinuation (if applicable)
Time frame: From baseline up to 24 months
Participant-caregiver assessment: Change from baseline in the Children's Dermatology Life Quality Index score
Time frame: From baseline up to 24 months
Participant-caregiver assessment: Change from baseline in the Infant's Dermatology Life Quality Index score
Time frame: From baseline up to 24 months
Participant-caregiver assessment: Change from baseline in the Dermatitis Family Impact (DFI) questionnaire
Time frame: From baseline up to 24 months
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
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
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
Physician assessment: Percent change from beseline in the Body Surface Area (BSA) (%) affected by AD
Time frame: From baseline up to 24 months
Physician assessment: Change in Proportion of patients with Validated Investigator's Global Assessment (IGA)
Time frame: From baseline up to 24 months
Physician assessment: Change from baseline in Biomarkers
Time frame: From baseline up to 24 months
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
Health Care Resource Utilization (HCRU) Questionnaire
Time frame: From baseline up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Sanofi at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age (time frame: At baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.