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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03849716
Recruitment Status : Active, not recruiting
First Posted : February 21, 2019
Last Update Posted : April 1, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment
Dermatitis Atopic Other: Blood sample Other: Cheek swab

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 161 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : May 29, 2026
Estimated Study Completion Date : May 29, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. Biomarker identification: Demographics [ Time Frame: Baseline ]
    Identification of biomarkers associated with demographic characteristics

  2. 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)

  3. 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

  4. 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

  5. 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

  6. Biomarker identification: Introduction of new systemic treatment [ Time Frame: Up to 5 years ]
    Identification of biomarkers associated with introduction of new systemic treatment

  7. Biomarker identification: Response to systemic treatment [ Time Frame: Up to 5 years ]
    Identification of biomarkers associated with response to systemic treatment

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849716


Locations
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United States, New York
Investigational Site United States
Bronx, New York, United States, 10463
Argentina
Investigational site Argentina
Argentina, Argentina
Australia
Investigational site Australia
Australia, Australia
Brazil
Investigational site Brazil
Brazil, Brazil
Canada
Investigational site Canada
Canada, Canada
Colombia
investigational site Colombia
Colombia, Colombia
France
investigational site France
France, France
Mexico
Investigational site Mexico
Mexico, Mexico
Netherlands
investigational site Netherlands
Netherlands, Netherlands
Spain
Investigational site Spain
Spain, Spain
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
Additional Information:

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03849716    
Other Study ID Numbers: LPS15496
U1111-1207-8876 ( Other Identifier: UTN )
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases