Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients (PEDISTAD BIOMARKER STUDY)

Study Overview
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Brief Summary
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Primary Objective: To explore associations between biomarkers of atopic dermatitis (AD) and: Disease state and time course of AD, Disease state and evolution of selected atopic comorbid conditions, Effectiveness of specific AD treatments.

Detailed Description
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The estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.

Official Title
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Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

Conditions
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Dermatitis Atopic

Intervention / Treatment
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* Other: Blood sample
* Other: Cheek swab


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Participation in the OBS15333 pediatric atopic dermatitis (AD) registry. Signed informed consent by the parent/legally acceptable representative and assent by the participant appropriate to the participant's age. Exclusion criteria: Not applicable. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with atopic dermatitis (AD)<br>Participants included in observational study OBS15333 (atopic dermatitis pediatric registry) who consent to enter this companion study LPS15496. Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enter either protocol, and neither protocol OBS15333 nor LPS15496 specifies assignment of any drug intervention | Other: Blood sample<br>* Blood samples obtained for biomarker analyses<br>Other: Cheek swab<br>* Cheek swab obtained for genetic analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker identification: Demographics | Identification of biomarkers associated with demographic characteristics | Baseline | 
| Biomarker identification: Baseline disease characteristics | Identification of biomarkers associated with disease characteristics at study entry (eg, disease severity, presence of other co-morbidities) | Baseline | 
| Biomarker identification: Changes in disease severity | Identification of biomarkers associated with disease severity increases/decreases (including remission) over time | Up to 5 years | 
| Biomarker evaluation: High versus low disease severity across participants | Examination of biomarker expression in participants with high disease severity versus those with low disease severity | Up to 5 years | 
| Biomarker identification: New presentation or resolution of atopic comorbidity | Identification of biomarkers associated with onset of a new atopic comorbidity or resolution of an existing atopic comorbidity | Up to 5 years | 
| Biomarker identification: Introduction of new systemic treatment | Identification of biomarkers associated with introduction of new systemic treatment | Up to 5 years | 
| Biomarker identification: Response to systemic treatment | Identification of biomarkers associated with response to systemic treatment | Up to 5 years | 
| Biomarker identification: Loss of response to systemic treatment | Identification of biomarkers associated with loss of response to systemic treatment | Up to 5 years | 
| Biomarker evaluation: Start of systemic therapy early in life versus later in life | Examination of whether biomarker expression in participants who started systemic therapy for AD early in life (within 6 months) differs from those who started it later in life | Up to 5 years |