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

NCT03849716 | Active Not Recruiting

• 2 other identifiers: LPS15496U1111-1207-8876
• Study Type: observational
• Target: 266
• Locations: 9 countries
• Sites: 48

Brief 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.

Conditions

Dermatitis Atopic

Outcome Measures

Primary Outcomes (9)

• Biomarker identification: Demographics

  Identification of biomarkers associated with demographic characteristics

  Baseline

• Biomarker identification: Baseline disease characteristics

  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

  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

  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

  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

  Identification of biomarkers associated with introduction of new systemic treatment

  Up to 5 years

• Biomarker identification: Response to systemic treatment

  Identification of biomarkers associated with response to systemic treatment

  Up to 5 years

• Biomarker identification: Loss of response to systemic treatment

  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

  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

Study Arms (1)

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; Other: Cheek swab

Interventions

Blood sample OTHER

Blood samples obtained for biomarker analyses

Participants with atopic dermatitis (AD)

Cheek swab OTHER

Cheek swab obtained for genetic analysis

Participants with atopic dermatitis (AD)

Eligibility Criteria

• Age: 0 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Not applicable.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (48)

C Squared Research Center Site Number : 8400068

Birmingham, Alabama, 35209, United States

Location

Cahaba Dermatology Site Number : 8400046

Birmingham, Alabama, 35244, United States

Location

C2 Research Center, LLC Site Number : 8400071

Montgomery, Alabama, 36117, United States

Location

Axis Clinical Trials Site Number : 8400025

Los Angeles, California, 90036, United States

Location

Madera Family Medical Group Site Number : 8400054

Madera, California, 93637, United States

Location

Fomat Medical Research, Inc. Site Number : 8400033

Oxnard, California, 93030, United States

Location

Amedica Research Institute, Inc. Site Number : 8400067

Hialeah, Florida, 33013, United States

Location

Eastern Research, Inc. Site Number : 8400032

Hialeah, Florida, 33013, United States

Location

Vista Health Research, LLC Site Number : 8400034

Miami, Florida, 33176, United States

Location

Pediatric & Adult Research Center Site Number : 8400040

Orlando, Florida, 32825, United States

Location

Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057

Albany, Georgia, 31707, United States

Location

IACT Health Site Number : 8400056

Columbus, Georgia, 31904, United States

Location

Northwestern University Feinberg School of Medicine Site Number : 8400001

Chicago, Illinois, 60611, United States

Location

NorthShore University HealthSystem Site Number : 8400064

Skokie, Illinois, 60077, United States

Location

Philip Fried, M.D., PLLC Site Number : 8400029

The Bronx, New York, 10463, United States

Location

Tiga Pediatrics, PC Site Number : 8400037

The Bronx, New York, 10463, United States

Location

Cincinnati Children's Hospital Medical Center Site Number : 8400017

Cincinnati, Ohio, 45229, United States

Location

Dermatology Associates of Mid-Ohio Site Number : 8400052

Marion, Ohio, 43302, United States

Location

MUSC Site Number : 8400013

Charleston, South Carolina, 29425, United States

Location

Allergic Disease and Asthma Research Center, PA Site Number : 8400048

Greenville, South Carolina, 29607, United States

Location

Amarillo Center for Clinical Research Site Number : 8400055

Amarillo, Texas, 79124, United States

Location

Heights Dermatology and Aesthetic Center Site Number : 8400065

Houston, Texas, 77008, United States

Location

Investigational Site Number : 0320002

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1181ACH, Argentina

Location

Investigational Site Number : 0320006

Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ, Argentina

Location

Investigational Site Number : 0320004

Rosario, Santa Fe Province, S2000DBS, Argentina

Location

Investigational Site Number : 0320003

Buenos Aires, C1061AAA, Argentina

Location

Investigational Site Number : 0320001

Ciudad Autonoma Bs As, C1121ABE, Argentina

Location

Investigational Site Number : 0360001

Westmead, New South Wales, 2145, Australia

Location

Investigational Site Number : 0360003

Melbourne, Victoria, 3010, Australia

Location

Universidade Federal do Paraná Site Number : 0760003

Curitiba, Paraná, 80060-000, Brazil

Location

HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004

Curitiba, Paraná, 80060-900, Brazil

Location

HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005

Curitiba, Paraná, 80060-900, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital Sao Paulo Site Number : 0760006

São Paulo, São Paulo, 04037-002, Brazil

Location

Clínica de Alergia Martti Antila Site Number : 0760001

Sorocaba, 18040-425, Brazil

Location

Investigational Site Number : 1240007

Calgary, Alberta, T3B 6A8, Canada

Location

Investigational Site Number : 1240005

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Investigational Site Number : 1240008

Toronto, Ontario, M5G 1X8, Canada

Location

Investigational Site Number : 1240006

Montreal, Quebec, H3T 1C5, Canada

Location

Investigational Site Number : 1700001

Bogotá, 110111, Colombia

Location

Investigational Site Number : 1700004

Bogotá, 111211, Colombia

Location

Investigational Site Number : 2500006

Marseille, 13385, France

Location

Investigational Site Number : 2500003

Paris, 75743, France

Location

Investigational Site Number : 4840003

Monterrey, Nuevo León, 64460, Mexico

Location

Investigational Site Number : 4840006

México, 06720, Mexico

Location

Investigational Site Number : 4840005

Tlalnepantla, 54055, Mexico

Location

Investigational Site Number : 5280005

Groningen, 9713 GZ, Netherlands

Location

Investigational Site Number : 5280003

Utrecht, 3508 GA, Netherlands

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: February 21, 2019
• Study Start: April 5, 2019
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (5); ME (3); FR (2); CO (2); NL (2); BR (6); AU (2); US (22); CA (4)