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

July 1, 2026 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

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

266

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
      • Buenos Aires, Argentina, C1061AAA
        • Investigational Site Number : 0320003
      • Ciudad Autonoma Bs As, Argentina, C1121ABE
        • Investigational Site Number : 0320001
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1056ABJ
        • Investigational Site Number : 0320006
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH
        • Investigational Site Number : 0320002
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DBS
        • Investigational Site Number : 0320004
  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Investigational Site Number : 0360001
    • Victoria
      • Melbourne, Victoria, Australia, 3010
        • Investigational Site Number : 0360003
  • Brazil
      • Sorocaba, Brazil, 18040-425
        • Clínica de Alergia Martti Antila Site Number : 0760001
    • Paraná
      • Curitiba, Paraná, Brazil, 80060-000
        • Universidade Federal do Paraná Site Number : 0760003
      • Curitiba, Paraná, Brazil, 80060-900
        • HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004
      • Curitiba, Paraná, Brazil, 80060-900
        • HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04037-002
        • Hospital Sao Paulo Site Number : 0760006
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Investigational Site Number : 1240007
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 0N2
        • Investigational Site Number : 1240005
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Investigational Site Number : 1240008
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Investigational Site Number : 1240006
  • Colombia
      • Bogotá, Colombia, 110111
        • Investigational Site Number : 1700001
      • Bogotá, Colombia, 111211
        • Investigational Site Number : 1700004
  • France
      • Marseille, France, 13385
        • Investigational Site Number : 2500006
      • Paris, France, 75743
        • Investigational Site Number : 2500003
  • Mexico
      • México, Mexico, 06720
        • Investigational Site Number : 4840006
      • Tlalnepantla, Mexico, 54055
        • Investigational Site Number : 4840005
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Investigational Site Number : 4840003
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Investigational Site Number : 5280005
      • Utrecht, Netherlands, 3508 GA
        • Investigational Site Number : 5280003
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • C Squared Research Center Site Number : 8400068
      • Birmingham, Alabama, United States, 35244
        • Cahaba Dermatology Site Number : 8400046
      • Montgomery, Alabama, United States, 36117
        • C2 Research Center, LLC Site Number : 8400071
    • California
      • Los Angeles, California, United States, 90036
        • Axis Clinical Trials Site Number : 8400025
      • Madera, California, United States, 93637
        • Madera Family Medical Group Site Number : 8400054
      • Oxnard, California, United States, 93030
        • Fomat Medical Research, Inc. Site Number : 8400033
    • Florida
      • Hialeah, Florida, United States, 33013
        • Amedica Research Institute, Inc. Site Number : 8400067
      • Hialeah, Florida, United States, 33013
        • Eastern Research, Inc. Site Number : 8400032
      • Miami, Florida, United States, 33176
        • Vista Health Research, LLC Site Number : 8400034
      • Orlando, Florida, United States, 32825
        • Pediatric & Adult Research Center Site Number : 8400040
    • Georgia
      • Albany, Georgia, United States, 31707
        • Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057
      • Columbus, Georgia, United States, 31904
        • IACT Health Site Number : 8400056
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine Site Number : 8400001
      • Skokie, Illinois, United States, 60077
        • NorthShore University HealthSystem Site Number : 8400064
    • New York
      • The Bronx, New York, United States, 10463
        • Philip Fried, M.D., PLLC Site Number : 8400029
      • The Bronx, New York, United States, 10463
        • Tiga Pediatrics, PC Site Number : 8400037
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center Site Number : 8400017
      • Marion, Ohio, United States, 43302
        • Dermatology Associates of Mid-Ohio Site Number : 8400052
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Site Number : 8400013
      • Greenville, South Carolina, United States, 29607
        • Allergic Disease and Asthma Research Center, PA Site Number : 8400048
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Center for Clinical Research Site Number : 8400055
      • Houston, Texas, United States, 77008
        • Heights Dermatology and Aesthetic Center Site Number : 8400065

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

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

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
Other: Blood sample
Blood samples obtained for biomarker analyses
Other: Cheek swab
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

Sanofi

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

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 (Actual)

April 20, 2026

Study Completion (Actual)

April 20, 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)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPS15496
  • U1111-1207-8876 (Registry Identifier: ICTRP)

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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