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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03849716




Registration number
NCT03849716
Ethics application status
Date submitted
17/01/2019
Date registered
21/02/2019
Date last updated
4/03/2021

Titles & IDs
Public title
Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients (PEDISTAD BIOMARKER STUDY)
Scientific 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
Secondary ID [1] 0 0
U1111-1207-8876
Secondary ID [2] 0 0
LPS15496
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dermatitis Atopic 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Blood sample
Other interventions - Cheek swab

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 interventions: Blood sample
Blood samples obtained for biomarker analyses

Other interventions: Cheek swab
Cheek swab obtained for genetic analysis

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Biomarker identification: Demographics - Identification of biomarkers associated with demographic characteristics
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Biomarker identification: Baseline disease characteristics - Identification of biomarkers associated with disease characteristics at study entry (eg, disease severity, presence of other co-morbidities)
Timepoint [2] 0 0
Baseline
Primary outcome [3] 0 0
Biomarker identification: Changes in disease severity - Identification of biomarkers associated with disease severity increases/decreases (including remission) over time
Timepoint [3] 0 0
Up to 5 years
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to 5 years
Primary outcome [5] 0 0
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
Timepoint [5] 0 0
Up to 5 years
Primary outcome [6] 0 0
Biomarker identification: Introduction of new systemic treatment - Identification of biomarkers associated with introduction of new systemic treatment
Timepoint [6] 0 0
Up to 5 years
Primary outcome [7] 0 0
Biomarker identification: Response to systemic treatment - Identification of biomarkers associated with response to systemic treatment
Timepoint [7] 0 0
Up to 5 years
Primary outcome [8] 0 0
Biomarker identification: Loss of response to systemic treatment - Identification of biomarkers associated with loss of response to systemic treatment
Timepoint [8] 0 0
Up to 5 years
Primary outcome [9] 0 0
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
Timepoint [9] 0 0
Up to 5 years

Eligibility
Key inclusion 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.
Minimum age
No limit
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational site Australia - Australia
Recruitment postcode(s) [1] 0 0
- Australia
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Argentina
State/province [2] 0 0
Argentina
Country [3] 0 0
Brazil
State/province [3] 0 0
Brazil
Country [4] 0 0
Canada
State/province [4] 0 0
Canada
Country [5] 0 0
Colombia
State/province [5] 0 0
Colombia
Country [6] 0 0
France
State/province [6] 0 0
France
Country [7] 0 0
Mexico
State/province [7] 0 0
Mexico
Country [8] 0 0
Netherlands
State/province [8] 0 0
Netherlands
Country [9] 0 0
Spain
State/province [9] 0 0
Spain

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03849716
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03849716