Dermatitis AtopicNCT03849716
Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients (PEDISTAD BIOMARKER STUDY)
An observational study of Dermatitis Atopic, run by Sanofi at 48 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 0 to 11 years
- Conditions the study is for
- Dermatitis Atopic
- What is being tested?
- Blood sample and Cheek swab
- How many people
- 266 participants
- Where
- 48 sitesin 9 countries
- Study dates
- 5 Apr 2019to 20 Apr 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 11 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Not applicable.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
48 sites in 9 countries.
48 sites in 9 countries
United States22 sites
Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057
Albany, Georgia, 31707
Amarillo Center for Clinical Research Site Number : 8400055
Amarillo, Texas, 79124
C Squared Research Center Site Number : 8400068
Birmingham, Alabama, 35209
Cahaba Dermatology Site Number : 8400046
Birmingham, Alabama, 35244
MUSC Site Number : 8400013
Charleston, South Carolina, 29425
Northwestern University Feinberg School of Medicine Site Number : 8400001
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center Site Number : 8400017
Cincinnati, Ohio, 45229
IACT Health Site Number : 8400056
Columbus, Georgia, 31904
Allergic Disease and Asthma Research Center, PA Site Number : 8400048
Greenville, South Carolina, 29607
Amedica Research Institute, Inc. Site Number : 8400067
Hialeah, Florida, 33013
Eastern Research, Inc. Site Number : 8400032
Hialeah, Florida, 33013
Heights Dermatology and Aesthetic Center Site Number : 8400065
Houston, Texas, 77008
Axis Clinical Trials Site Number : 8400025
Los Angeles, California, 90036
Madera Family Medical Group Site Number : 8400054
Madera, California, 93637
Dermatology Associates of Mid-Ohio Site Number : 8400052
Marion, Ohio, 43302
Vista Health Research, LLC Site Number : 8400034
Miami, Florida, 33176
C2 Research Center, LLC Site Number : 8400071
Montgomery, Alabama, 36117
Pediatric & Adult Research Center Site Number : 8400040
Orlando, Florida, 32825
Fomat Medical Research, Inc. Site Number : 8400033
Oxnard, California, 93030
NorthShore University HealthSystem Site Number : 8400064
Skokie, Illinois, 60077
Philip Fried, M.D., PLLC Site Number : 8400029
The Bronx, New York, 10463
Tiga Pediatrics, PC Site Number : 8400037
The Bronx, New York, 10463
Brazil6 sites
Universidade Federal do Paraná Site Number : 0760003
Curitiba, Paraná, 80060-000
HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004
Curitiba, Paraná, 80060-900
HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005
Curitiba, Paraná, 80060-900
Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002
Porto Alegre, Rio Grande do Sul, 90020-090
Hospital Sao Paulo Site Number : 0760006
São Paulo, São Paulo, 04037-002
Clínica de Alergia Martti Antila Site Number : 0760001
Sorocaba, 18040-425
Argentina5 sites
Investigational Site Number : 0320003
Buenos Aires, C1061AAA
Investigational Site Number : 0320001
Ciudad Autonoma Bs As, C1121ABE
Investigational Site Number : 0320006
Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ
Investigational Site Number : 0320002
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1181ACH
Investigational Site Number : 0320004
Rosario, Santa Fe Province, S2000DBS
Canada4 sites
Investigational Site Number : 1240007
Calgary, Alberta, T3B 6A8
Investigational Site Number : 1240006
Montreal, Quebec, H3T 1C5
Investigational Site Number : 1240008
Toronto, Ontario, M5G 1X8
Investigational Site Number : 1240005
Winnipeg, Manitoba, R3C 0N2
Mexico3 sites
Investigational Site Number : 4840006
México, 06720
Investigational Site Number : 4840003
Monterrey, Nuevo León, 64460
Investigational Site Number : 4840005
Tlalnepantla, 54055
Australia2 sites
Investigational Site Number : 0360003
Melbourne, Victoria, 3010
Investigational Site Number : 0360001
Westmead, New South Wales, 2145
Colombia2 sites
Investigational Site Number : 1700001
Bogotá, 110111
Investigational Site Number : 1700004
Bogotá, 111211
France2 sites
Investigational Site Number : 2500006
Marseille, 13385
Investigational Site Number : 2500003
Paris, 75743
Netherlands2 sites
Investigational Site Number : 5280005
Groningen, 9713 GZ
Investigational Site Number : 5280003
Utrecht, 3508 GA
About this study
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
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.
Read the detailed description
The estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.
- Conditions
- Dermatitis Atopic
- Being tested
- Blood sample, Cheek swab
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood samples obtained for biomarker analyses
Cheek swabOther
Cheek swab obtained for genetic analysis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Blood sample; Other: Cheek swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker identification: Demographics
Identification of biomarkers associated with demographic characteristics
Measured: Baseline
Biomarker identification: Baseline disease characteristics
Identification of biomarkers associated with disease characteristics at study entry (eg, disease severity, presence of other co-morbidities)
Measured: Baseline
Biomarker identification: Changes in disease severity
Identification of biomarkers associated with disease severity increases/decreases (including remission) over time
Measured: 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
Measured: 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
Measured: Up to 5 years
Biomarker identification: Introduction of new systemic treatment
Identification of biomarkers associated with introduction of new systemic treatment
Measured: Up to 5 years
Biomarker identification: Response to systemic treatment
Identification of biomarkers associated with response to systemic treatment
Measured: Up to 5 years
Biomarker identification: Loss of response to systemic treatment
Identification of biomarkers associated with loss of response to systemic treatment
Measured: 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
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start5 Apr 2019
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis AtopicStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 266 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849716
- Sponsor's protocol ID
- LPS15496
- Other IDs
- U1111-1207-8876
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2019
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03849716
- Acronym / sponsor ID
- LPS15496
- Conditions
- Dermatitis Atopic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with atopic dermatitis (AD) | – | Other: Blood sample, Other: Cheek swabParticipants 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 |
Who may qualify
- Ages
- 0 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Not applicable.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood samples obtained for biomarker analyses | Other | Participants with atopic dermatitis (AD) |
| Cheek swabCheek swab obtained for genetic analysis | Other | Participants with atopic dermatitis (AD) |
Primary outcome
Biomarker identification: Demographics
Time frame: Baseline
Identification of biomarkers associated with demographic characteristics
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)
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
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
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
Biomarker identification: Introduction of new systemic treatment
Time frame: Up to 5 years
Identification of biomarkers associated with introduction of new systemic treatment
Biomarker identification: Response to systemic treatment
Time frame: Up to 5 years
Identification of biomarkers associated with response to systemic treatment
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
48 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis Atopic, run by Sanofi at 48 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Brazil, Argentina, Canada, Mexico and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker identification: Demographics (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.