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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1207-8876 | Registry Identifier | ICTRP |
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Primary Objective:
To explore associations between biomarkers of atopic dermatitis (AD) and:
The estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | Blood samples obtained for biomarker analyses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion 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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C Squared Research Center Site Number : 8400068 | Birmingham | Alabama | 35209 | United States | ||
| Cahaba Dermatology Site Number : 8400046 |
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| Cheek swab | Other | Cheek swab obtained for genetic analysis |
|
| 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 |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| C2 Research Center, LLC Site Number : 8400071 | Montgomery | Alabama | 36117 | United States |
| Axis Clinical Trials Site Number : 8400025 | Los Angeles | California | 90036 | United States |
| Madera Family Medical Group Site Number : 8400054 | Madera | California | 93637 | United States |
| Fomat Medical Research, Inc. Site Number : 8400033 | Oxnard | California | 93030 | United States |
| Amedica Research Institute, Inc. Site Number : 8400067 | Hialeah | Florida | 33013 | United States |
| Eastern Research, Inc. Site Number : 8400032 | Hialeah | Florida | 33013 | United States |
| Vista Health Research, LLC Site Number : 8400034 | Miami | Florida | 33176 | United States |
| Pediatric & Adult Research Center Site Number : 8400040 | Orlando | Florida | 32825 | United States |
| Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057 | Albany | Georgia | 31707 | United States |
| IACT Health Site Number : 8400056 | Columbus | Georgia | 31904 | United States |
| Northwestern University Feinberg School of Medicine Site Number : 8400001 | Chicago | Illinois | 60611 | United States |
| NorthShore University HealthSystem Site Number : 8400064 | Skokie | Illinois | 60077 | United States |
| Philip Fried, M.D., PLLC Site Number : 8400029 | The Bronx | New York | 10463 | United States |
| Tiga Pediatrics, PC Site Number : 8400037 | The Bronx | New York | 10463 | United States |
| Cincinnati Children's Hospital Medical Center Site Number : 8400017 | Cincinnati | Ohio | 45229 | United States |
| Dermatology Associates of Mid-Ohio Site Number : 8400052 | Marion | Ohio | 43302 | United States |
| MUSC Site Number : 8400013 | Charleston | South Carolina | 29425 | United States |
| Allergic Disease and Asthma Research Center, PA Site Number : 8400048 | Greenville | South Carolina | 29607 | United States |
| Amarillo Center for Clinical Research Site Number : 8400055 | Amarillo | Texas | 79124 | United States |
| Heights Dermatology and Aesthetic Center Site Number : 8400065 | Houston | Texas | 77008 | United States |
| Investigational Site Number : 0320002 | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1181ACH | Argentina |
| Investigational Site Number : 0320006 | Ciudad Autonoma de Buenos Aire | Buenos Aires | C1056ABJ | Argentina |
| Investigational Site Number : 0320004 | Rosario | Santa Fe Province | S2000DBS | Argentina |
| Investigational Site Number : 0320003 | Buenos Aires | C1061AAA | Argentina |
| Investigational Site Number : 0320001 | Ciudad Autonoma Bs As | C1121ABE | Argentina |
| Investigational Site Number : 0360001 | Westmead | New South Wales | 2145 | Australia |
| Investigational Site Number : 0360003 | Melbourne | Victoria | 3010 | Australia |
| Universidade Federal do Paraná Site Number : 0760003 | Curitiba | Paraná | 80060-000 | Brazil |
| HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004 | Curitiba | Paraná | 80060-900 | Brazil |
| HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005 | Curitiba | Paraná | 80060-900 | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002 | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital Sao Paulo Site Number : 0760006 | São Paulo | São Paulo | 04037-002 | Brazil |
| Clínica de Alergia Martti Antila Site Number : 0760001 | Sorocaba | 18040-425 | Brazil |
| Investigational Site Number : 1240007 | Calgary | Alberta | T3B 6A8 | Canada |
| Investigational Site Number : 1240005 | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Investigational Site Number : 1240008 | Toronto | Ontario | M5G 1X8 | Canada |
| Investigational Site Number : 1240006 | Montreal | Quebec | H3T 1C5 | Canada |
| Investigational Site Number : 1700001 | Bogotá | 110111 | Colombia |
| Investigational Site Number : 1700004 | Bogotá | 111211 | Colombia |
| Investigational Site Number : 2500006 | Marseille | 13385 | France |
| Investigational Site Number : 2500003 | Paris | 75743 | France |
| Investigational Site Number : 4840003 | Monterrey | Nuevo León | 64460 | Mexico |
| Investigational Site Number : 4840006 | México | 06720 | Mexico |
| Investigational Site Number : 4840005 | Tlalnepantla | 54055 | Mexico |
| Investigational Site Number : 5280005 | Groningen | 9713 GZ | Netherlands |
| Investigational Site Number : 5280003 | Utrecht | 3508 GA | Netherlands |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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