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NCT03849716 Clinical Trial

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

Dermatitis Atopic Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03849716
Other study ID # LPS15496
Secondary ID U1111-1207-8876
Status Active, not recruiting
Phase
First received
Last updated
Start date April 5, 2019
Est. completion date September 30, 2026

Study information
Verified date April 2024
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 266
Est. completion date September 30, 2026
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 0 Years to 11 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Argentina Investigational Site Number : 0320003 Buenos Aires
Argentina Investigational Site Number : 0320001 Ciudad Autonoma Bs As
Argentina Investigational Site Number : 0320006 Ciudad Autonoma de Buenos Aire Buenos Aires
Argentina Investigational Site Number : 0320002 Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Investigational Site Number : 0320004 Rosario Santa Fe
Australia Investigational Site Number : 0360003 Melbourne Victoria
Australia Investigational Site Number : 0360001 Westmead New South Wales
Brazil HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004 Curitiba Paraná
Brazil HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005 Curitiba Paraná
Brazil Universidade Federal do Paraná Site Number : 0760003 Curitiba Paraná
Brazil Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002 Porto Alegre Rio Grande Do Sul
Brazil Hospital Sao Paulo Site Number : 0760006 São Paulo São Paulo
Brazil Clínica de Alergia Martti Antila Site Number : 0760001 Sorocaba
Canada Investigational Site Number : 1240007 Calgary Alberta
Canada Investigational Site Number : 1240006 Montreal Quebec
Canada Investigational Site Number : 1240008 Toronto Ontario
Canada Investigational Site Number : 1240005 Winnipeg Manitoba
Colombia Investigational Site Number : 1700001 Bogota
Colombia Investigational Site Number : 1700004 Bogota
France Investigational Site Number : 2500006 Marseille cedex 5
France Investigational Site Number : 2500003 Paris Cedex 15
Mexico Investigational Site Number : 4840006 Mexico
Mexico Investigational Site Number : 4840003 Monterrey Nuevo León
Mexico Investigational Site Number : 4840005 Tlalnepantla
Netherlands Investigational Site Number : 5280005 Groningen
Netherlands Investigational Site Number : 5280003 Utrecht
United States Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057 Albany Georgia
United States Amarillo Center for Clinical Research Site Number : 8400055 Amarillo Texas
United States C Squared Research Center Site Number : 8400068 Birmingham Alabama
United States Cahaba Dermatology Site Number : 8400046 Birmingham Alabama
United States Philip Fried, M.D., PLLC Site Number : 8400029 Bronx New York
United States Tiga Pediatrics, PC Site Number : 8400037 Bronx New York
United States MUSC Site Number : 8400013 Charleston South Carolina
United States Northwestern University Feinberg School of Medicine Site Number : 8400001 Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Site Number : 8400017 Cincinnati Ohio
United States IACT Health Site Number : 8400056 Columbus Georgia
United States Allergic Disease and Asthma Research Center, PA Site Number : 8400048 Greenville South Carolina
United States Amedica Research Institute, Inc. Site Number : 8400067 Hialeah Florida
United States Eastern Research, Inc. Site Number : 8400032 Hialeah Florida
United States Heights Dermatology and Aesthetic Center Site Number : 8400065 Houston Texas
United States Axis Clinical Trials Site Number : 8400025 Los Angeles California
United States Madera Family Medical Group Site Number : 8400054 Madera California
United States Dermatology Associates of Mid-Ohio Site Number : 8400052 Marion Ohio
United States Vista Health Research, LLC Site Number : 8400034 Miami Florida
United States C2 Research Center, LLC Site Number : 8400071 Montgomery Alabama
United States Pediatric & Adult Research Center Site Number : 8400040 Orlando Florida
United States Fomat Medical Research, Inc. Site Number : 8400033 Oxnard California
United States NorthShore University HealthSystem Site Number : 8400064 Skokie Illinois

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Colombia,  France,  Mexico,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Biomarker identification: Demographics Identification of biomarkers associated with demographic characteristics Baseline
Primary Biomarker identification: Baseline disease characteristics Identification of biomarkers associated with disease characteristics at study entry (eg, disease severity, presence of other co-morbidities) Baseline
Primary Biomarker identification: Changes in disease severity Identification of biomarkers associated with disease severity increases/decreases (including remission) over time Up to 5 years
Primary 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
Primary 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
Primary Biomarker identification: Introduction of new systemic treatment Identification of biomarkers associated with introduction of new systemic treatment Up to 5 years
Primary Biomarker identification: Response to systemic treatment Identification of biomarkers associated with response to systemic treatment Up to 5 years
Primary Biomarker identification: Loss of response to systemic treatment Identification of biomarkers associated with loss of response to systemic treatment Up to 5 years
Primary 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
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