- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03849716
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
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)
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
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Argentina, Argentina
- investigational site Argentina
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Australia, Australia
- investigational site AUSTRALIA
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Brazil, Brazil
- investigational site Brazil
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Canada, Canada
- Investigational site Canada
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Colombia, Colombia
- Investigational site Colombia
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France, France
- Investigational site France
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Mexico, Mexico
- Investigational site Mexico
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Netherlands, Netherlands
- Investigational site Netherlands
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Spain, Spain
- investigational site Spain
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New York
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Bronx, New York, United States, 10463
- Investigational site UNITED STATES
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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 |
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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
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Blood samples obtained for biomarker analyses
Cheek swab obtained for genetic analysis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Biomarker identification: Demographics
Time Frame: Baseline
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Identification of biomarkers associated with demographic characteristics
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Baseline
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Biomarker identification: Baseline disease characteristics
Time Frame: Baseline
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Identification of biomarkers associated with disease characteristics at study entry (eg, disease severity, presence of other co-morbidities)
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Baseline
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Biomarker identification: Changes in disease severity
Time Frame: Up to 5 years
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Identification of biomarkers associated with disease severity increases/decreases (including remission) over time
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Up to 5 years
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Biomarker evaluation: High versus low disease severity across participants
Time Frame: Up to 5 years
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Examination of biomarker expression in participants with high disease severity versus those with low disease severity
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Up to 5 years
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Biomarker identification: New presentation or resolution of atopic comorbidity
Time Frame: Up to 5 years
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Identification of biomarkers associated with onset of a new atopic comorbidity or resolution of an existing atopic comorbidity
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Up to 5 years
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Biomarker identification: Introduction of new systemic treatment
Time Frame: Up to 5 years
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Identification of biomarkers associated with introduction of new systemic treatment
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Up to 5 years
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Biomarker identification: Response to systemic treatment
Time Frame: Up to 5 years
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Identification of biomarkers associated with response to systemic treatment
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Up to 5 years
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Biomarker identification: Loss of response to systemic treatment
Time Frame: Up to 5 years
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Identification of biomarkers associated with loss of response to systemic treatment
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Up to 5 years
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Biomarker evaluation: Start of systemic therapy early in life versus later in life
Time Frame: Up to 5 years
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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
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Up to 5 years
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- LPS15496
- U1111-1207-8876 (Other Identifier: UTN)
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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