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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 30, 2026

Detailed Description

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

Interventions

  • Other: Blood sample
    • Blood samples obtained for biomarker analyses
  • Other: Cheek swab
    • Cheek swab obtained for genetic analysis

Arms, Groups and Cohorts

  • Participants with atopic dermatitis (AD)
    • 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

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 0 Years

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Sciences & Operations, Study Director, Sanofi

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