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

December 14, 2022 updated by: Sanofi

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Argentina, Argentina
        • investigational site Argentina
      • Australia, Australia
        • investigational site AUSTRALIA
      • Brazil, Brazil
        • investigational site Brazil
      • Canada, Canada
        • Investigational site Canada
      • Colombia, Colombia
        • Investigational site Colombia
      • France, France
        • Investigational site France
      • Mexico, Mexico
        • Investigational site Mexico
      • Netherlands, Netherlands
        • Investigational site Netherlands
      • Spain, Spain
        • investigational site Spain
    • New York
      • Bronx, New York, United States, 10463
        • Investigational site UNITED STATES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with moderate to severe AD whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable, who are included in observational study OBS15333 and consent to enter this companion study LPS15496.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Blood samples obtained for biomarker analyses
Cheek swab obtained for genetic analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarker identification: Demographics
Time Frame: Baseline
Identification of biomarkers associated with demographic characteristics
Baseline
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)
Baseline
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
Up to 5 years
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
Up to 5 years
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
Up to 5 years
Biomarker identification: Introduction of new systemic treatment
Time Frame: Up to 5 years
Identification of biomarkers associated with introduction of new systemic treatment
Up to 5 years
Biomarker identification: Response to systemic treatment
Time Frame: Up to 5 years
Identification of biomarkers associated with response to systemic treatment
Up to 5 years
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
Up to 5 years
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
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2019

Primary Completion (Anticipated)

September 30, 2026

Study Completion (Anticipated)

September 30, 2026

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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