Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1211-9437 | Registry Identifier | ICTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Objectives:
Secondary Objectives:
The study duration is 120 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with atopic dermatitis (AD) | Participants receive AD therapy as part of their usual care as determined by their physician independent of decision to enroll in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other | Treatment as per standard practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient demographics | Baseline (Month 0) | |
| Medical history of selected atopic diseases and comorbidities | Baseline (Month 0) | |
| Age at onset of atopic dermatitis (AD) | Baseline (Month 0) | |
| Personal and family history of AD and selected atopic diseases | Baseline (Month 0) | |
| All prior and current systemic AD treatment | Baseline (Month 0) | |
| All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment) | Baseline (Month 0) | |
| Presence/severity of AD and selected atopic comorbid conditions | Baseline to Month 120 | |
| Therapy for selected atopic comorbid conditions | Baseline to Month 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Days missed from school for the patient and days missed from work for the primary caregiver due to AD | Baseline to Month 120 | |
| Visits to healthcare professionals (HCPs) | Baseline to Month 120 | |
Not provided
Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Pediatric patients with moderate to severe AD whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.
Not provided
| 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 & Skin Health Center- Site Number : 8400046 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40971133 | Derived | Paller AS, Marcoux D, Ramien M, Baselga E, Carvalho VO, Ardusso LRF, de Graaf M, Pasmans S, Toledo-Bahena M, Rubin C, Joyce JC, Lee LW, Gupta R, Adams B, Ardeleanu M, Zhang A. Systemic Treatments in Moderate-to-Severe Atopic Dermatitis in Pediatric Patients up to 12 Years of Age: Real-World Treatment Outcomes from the PEDISTAD Registry. Am J Clin Dermatol. 2025 Nov;26(6):1031-1043. doi: 10.1007/s40257-025-00962-8. Epub 2025 Sep 19. | |
| 39389429 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Treatments and prescribing patterns for pediatric AD |
| Baseline to Month 120 |
| Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI]) | Baseline to Month 120 |
| Changes in physician assessment of disease burden (Body Surface Area [BSA]) | Baseline to Month 120 |
| Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM) | Baseline to Month 120 |
| Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL) | Baseline to Month 120 |
| Change in PRO: Dermatitis Family Impact (DFI) | Baseline to Month 120 |
| Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS | Baseline to Month 120 |
| Change in PRO: Caregiver Global Assessment of Disease (CGAD) | Baseline to Month 120 |
| Change in PRO: Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit | Baseline to Month 120 |
| Change in PRO: Total Nasal Symptom Score (TNSS) | Baseline to Month 120 |
| Change in PRO: Pediatric Asthma Questionnaire (PAQ) | Baseline to Month 120 |
| Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5) | Baseline to Month 120 |
| Adverse event (AE) reporting | Baseline to Month 120 |
| Birmingham |
| Alabama |
| 35244 |
| United States |
| C2 Research Center, LLC- Site Number : 8400071 | Montgomery | Alabama | 36117 | United States |
| Phoenix Children's Hospital, Inc.- Site Number : 8400015 | Phoenix | Arizona | 85016 | United States |
| Orange County Research Institute- Site Number : 8400028 | Anaheim | California | 92801 | 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 |
| Carey Chronis, MD, FAAP- Site Number : 8400033 | Ventura | California | 93003 | United States |
| Daxia Trials- Site Number : 8400082 | Boca Raton | Florida | 33431 | United States |
| Frieder Dermatology- Site Number : 8400085 | Boca Raton | Florida | 33487 | United States |
| Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology, LLC- Site Number : 8400072 | Coral Gables | Florida | 33146 | United States |
| Green Dermatology and Cosmetic Center. Site Number : 8400078 | Deerfield Beach | Florida | 33441 | 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 |
| Premier Dermatology Partners- Site Number : 8400075 | Miami | Florida | 33137 | United States |
| Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400074 | Miami | Florida | 33155 | 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 |
| Elias Dermatology LLC- Site Number : 8400086 | Pembroke Pines | Florida | 33024 | United States |
| Elias Dermatology LLC- Site Number : 8400087 | Pembroke Pines | Florida | 33024 | United States |
| Centricity Research Talbotton - DBA IACT Health Research at Talbotton 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 - Skokie- Site Number : 8400064 | Skokie | Illinois | 60077 | United States |
| The Indiana Clinical Trial Center - Plainfield - Edwards Drive- Site Number : 8400007 | Plainfield | Indiana | 46168 | United States |
| The Indiana Clinical Trials Center, PC Site Number : 8400007 | Plainfield | Indiana | 46168 | United States |
| Michael W. Simon, M.D., PSC- Site Number : 8400073 | Lexington | Kentucky | 40517 | United States |
| Dermatology Associates PC- Site Number : 8400049 | Rockville | Maryland | 20850 | United States |
| Michigan Dermatology Institute Site Number : 8400059 | Waterford | Michigan | 48328 | United States |
| Tokunbo T. Dada, MD PA- Site Number : 8400079 | Irvington | New Jersey | 07111 | United States |
| Family Pediatrics Iwuozo L Obilo Md- Site Number : 8400077 | Newark | New Jersey | 07104 | United States |
| Providence Medical Center- Site Number : 8400081 | North Plainfield | New Jersey | 07060 | United States |
| VAMA Medical Health Center- Site Number : 8400083 | Union | New Jersey | 07083-5714 | United States |
| Park Plaza Dermatology- Site Number : 8400080 | New York | New York | 10019 | 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 |
| UNC Hospitals- Site Number : 8400016 | Chapel Hill | North Carolina | 27514 | United States |
| 2G Clinical Research Services- Site Number : 8400031 | Durham | North Carolina | 27713 | United States |
| Clinical Research Of Gastonia- Site Number : 8400041 | Gastonia | North Carolina | 28054 | 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 |
| ADAC Research- Site Number : 8400048 | Greenville | South Carolina | 29607 | United States |
| Amarillo Center for Clinical Research- Site Number : 8400055 | Amarillo | Texas | 79124 | United States |
| Heights Dermatology & Aesthetic Center- Site Number : 8400065 | Houston | Texas | 77008 | United States |
| The Dermatology Institute of South Texas- Site Number : 8400076 | McAllen | Texas | 78501 | United States |
| Medical College Of Wisconsin- Site Number : 8400008 | Milwaukee | Wisconsin | 53226 | United States |
| Investigational Site Number : 0320009 | Bahía Blanca | Buenos Aires | 8000 | Argentina |
| Investigational Site Number : 0320003 | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1425BEA | Argentina |
| Investigational Site Number : 0320004 | Rosario | Santa Fe Province | 2000 | Argentina |
| Investigational Site Number : 0320007 | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Investigational Site Number : 0320006 | Buenos Aires | 1056 | Argentina |
| Investigational Site Number : 0320001 | Buenos Aires | 1121 | Argentina |
| Investigational Site Number : 0320002 | Buenos Aires | 1181 | Argentina |
| Investigational Site Number : 0320008 | Buenos Aires | 1181 | Argentina |
| Investigational Site Number : 0320005 | Ciudad Autonoma Buenos Aires | C1270AAN | Argentina |
| Investigational Site Number : 0320010 | Córdoba | 5000 | Argentina |
| Investigational Site Number : 0320013 | Salta | A4400 | Argentina |
| Investigational Site Number : 0320007 | San Miguel de Tucumán | T4000AXL | Argentina |
| Investigational Site Number : 0360008 | Kogarah | New South Wales | 2217 | Australia |
| Investigational Site Number : 0360011 | Sydney | New South Wales | 2010 | Australia |
| Investigational Site Number : 0360009 | Sydney | New South Wales | 2560 | Australia |
| Investigational Site Number : 0360010 | Melbourne | Victoria | 3128 | Australia |
| Investigational Site Number : 0360003 | Parkville | Victoria | 3052 | Australia |
| Investigational Site Number : 0360007 | Richmond | Victoria | 3121 | Australia |
| Universidade Federal do Paraná- Site Number : 0760003 | Curitiba | Paraná | 80060-000 | Brazil |
| Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760004 | Curitiba | Paraná | 80060-900 | Brazil |
| Hospital de Clinicas da Universidade Federal do Parana- 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 |
| Clinica de Alergia Martti Antila- Site Number : 0760001 | Sorocaba | São Paulo | 18040-425 | Brazil |
| IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760009 | Rio de Janeiro | 22470-220 | Brazil |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto- Site Number : 0760007 | Sao Jose Rio Preto | 15090-000 | Brazil |
| Hospital Sao Paulo- Site Number : 0760006 | São Paulo | 04037-002 | Brazil |
| Investigational Site Number : 1240004 | Calgary | Alberta | T3A 2N1 | Canada |
| Investigational Site Number : 1240007 | Calgary | Alberta | T3B 6A8 | Canada |
| Investigational Site Number : 1240005 | Winnipeg | Manitoba | R3C ON2 | Canada |
| Investigational Site Number : 1240010 | Halifax | Nova Scotia | B3K 5R3 | Canada |
| Investigational Site Number : 1240001 | Markham | Ontario | L3P 1X2 | Canada |
| Investigational Site Number : 1240008 | Toronto | Ontario | M5G 1X8 | Canada |
| Investigational Site Number : 1240006 | Montreal | Quebec | H3T 1C5 | Canada |
| Investigational Site Number : 1240009 | Regina | Saskatchewan | S4V 1R9 | Canada |
| Investigational Site Number : 1560004 | Beijing | 100045 | China |
| Investigational Site Number : 1560006 | Changsha | 410007 | China |
| Investigational Site Number : 1560001 | Chongqing | 400014 | China |
| Investigational Site Number : 1560012 | Guangzhou | 510018 | China |
| Investigational Site Number : 1560007 | Harbin | 150010 | China |
| Investigational Site Number : 1560005 | Shanghai | 201102 | China |
| Investigational Site Number : 1560011 | Shenzhen | 518020 | China |
| Investigational Site Number : 1560002 | Suzhou | 215025 | China |
| Investigational Site Number : 1560008 | Xuzhou | 221002 | China |
| Investigational Site Number : 1700006 | Barranquilla | 080002 | Colombia |
| Investigational Site Number : 1700001 | Bogotá | 110111 | Colombia |
| Investigational Site Number : 1700004 | Bogotá | 111211 | Colombia |
| Investigational Site Number : 2080002 | København NV | 2400 | Denmark |
| Investigational Site Number : 2500008 | Argenteuil | 95107 | France |
| Investigational Site Number : 2500001 | Bordeaux | 33800 | France |
| Investigational Site Number : 2500010 | Lille | 59020 | France |
| Investigational Site Number : 2500006 | Marseille | 13385 | France |
| Investigational Site Number : 2500005 | Martigues | 13500 | France |
| Investigational Site Number : 2500002 | Nantes | 44093 | France |
| Investigational Site Number : 2500003 | Paris | 75015 | France |
| Investigational Site Number : 2500011 | Toulouse | 31059 | France |
| Investigational Site Number : 3000004 | Larissa | 411 10 | Greece |
| Investigational Site Number : 3000005 | Thessaloniki | 54642 | Greece |
| Investigational Site Number : 3000003 | Thessaloniki | 54643 | Greece |
| Investigational Site Number : 3000002 | Thessaloniki | 564 29 | Greece |
| Investigational Site Number : 3760003 | Beersheba | 8457108 | Israel |
| Investigational Site Number : 3760004 | Haifa | 3104802 | Israel |
| Investigational Site Number : 3760005 | Kefar Sava | 4428164 | Israel |
| Investigational Site Number : 3760001 | Ramat Gan | 5262100 | Israel |
| Investigational Site Number : 3760002 | Rehovot | 7610001 | Israel |
| Investigational Site Number : 3800004 | Terracina | Latina | 04019 | Italy |
| Investigational Site Number : 3800008 | Naples | Napoli | 80131 | Italy |
| Investigational Site Number : 3800011 | Padua | Padova | 35128 | Italy |
| Investigational Site Number : 3800006 | Padua | Veneto | 35128 | Italy |
| Investigational Site Number : 3800012 | Bari | 70124 | Italy |
| Investigational Site Number : 3800003 | Bologna | 40138 | Italy |
| Investigational Site Number : 3800014 | Brescia | 25123 | Italy |
| Investigational Site Number : 3800010 | Catania | 95123 | Italy |
| Investigational Site Number : 3800001 | Milan | 20122 | Italy |
| Investigational Site Number : 3800005 | Naples | 80131 | Italy |
| Investigational Site Number : 3800015 | Pavia | 27100 | Italy |
| Investigational Site Number : 3800009 | Perugia | 06129 | Italy |
| Investigational Site Number : 3800013 | Reggio Emilia | 42100 | Italy |
| Investigational Site Number : 3800018 | Roma | 00137 | Italy |
| Investigational Site Number : 3800007 | Trieste | 34137 | Italy |
| Investigational Site Number : 3920009 | Sagamihara | Kanagawa | 252-0315 | Japan |
| Investigational Site Number : 3920016 | Yokohama | Kanagawa | 221-0825 | Japan |
| Investigational Site Number : 3920010 | Tsu | Mie-ken | 514-0125 | Japan |
| Investigational Site Number : 3920003 | Habikino | Osaka | 583-8588 | Japan |
| Investigational Site Number : 3920011 | Fuchū | Tokyo | 183-8561 | Japan |
| Investigational Site Number : 3920018 | Fukuoka | 813-0017 | Japan |
| Investigational Site Number : 3920017 | Fukuyama-shi | 721-8511 | Japan |
| Investigational Site Number : 3920002 | Hiroshima | 734-8551 | Japan |
| Investigational Site Number : 3920015 | Kumagaya-shi | 360-0018 | Japan |
| Investigational Site Number : 3920004 | Kyoto | 602-8566 | Japan |
| Investigational Site Number : 3920012 | Nagasaki | 852-8501 | Japan |
| Investigational Site Number : 3920020 | Nagoya | 460-0001 | Japan |
| Investigational Site Number : 3920008 | Obu-shi | 474-8710 | Japan |
| Investigational Site Number : 3920005 | Osakasayama-shi | 589-8511 | Japan |
| Investigational Site Number : 3920014 | Sendai | 983-8512 | Japan |
| Investigational Site Number : 3920019 | Sendai | 989-3126 | Japan |
| Investigational Site Number : 3920001 | Tokyo | 157-8535 | Japan |
| Investigational Site Number : 3920016 | Yokohama | 221-0825 | Japan |
| Investigational Site Number : 4840010 | Cuernavaca | Morelos | 62290 | Mexico |
| Investigational Site Number : 4840003 | Monterrey | Nuevo León | 64460 | Mexico |
| Investigational Site Number : 4840009 | Monterrey | Nuevo León | 64460 | Mexico |
| Investigational Site Number : 4840008 | Monterrey | Nuevo León | 64718 | Mexico |
| Investigational Site Number : 4840001 | México | 04530 | Mexico |
| Investigational Site Number : 4840006 | México | 06720 | Mexico |
| Investigational Site Number : 4840004 | Puebla City | 72190 | Mexico |
| Investigational Site Number : 4840005 | Tlalnepantla | 54055 | Mexico |
| Investigational Site Number : 5280001 | Amsterdam | 1105 AZ | Netherlands |
| Investigational Site Number : 5280005 | Groningen | 9713 GR | Netherlands |
| Investigational Site Number : 5280002 | Rotterdam | 3015 CE | Netherlands |
| Investigational Site Number : 5280006 | The Hague | 2566 MJ | Netherlands |
| Investigational Site Number : 5280003 | Utrecht | 3508 GA | Netherlands |
| Investigational Site Number : 5780001 | Bergen | 5021 | Norway |
| Investigational Site Number : 5780002 | Oslo | 0027 | Norway |
| Investigational Site Number : 5780003 | Stavanger | 4011 | Norway |
| Investigational Site Number : 6200003 | Braga | 4710-243 | Portugal |
| Investigational Site Number : 6200005 | Lisbon | 1169-050 | Portugal |
| Investigational Site Number : 6200001 | Lisbon | 1649-035 | Portugal |
| Investigational Site Number : 6200006 | Porto | 4200-319 | Portugal |
| Investigational Site Number : 6430005 | Moscow | 109240 | Russia |
| Investigational Site Number : 6430002 | Moscow | 115478 | Russia |
| Investigational Site Number : 6430003 | Moscow | 117513 | Russia |
| Investigational Site Number : 6430001 | Moscow | 119991 | Russia |
| Investigational Site Number : 6430004 | Moscow | 125373 | Russia |
| Investigational Site Number : 4100008 | Ansan-si | Gyeonggi-do | 15355 | South Korea |
| Investigational Site Number : 4100002 | Suwon | Gyeonggi-do | 16499 | South Korea |
| Investigational Site Number : 4100007 | Incheon | Incheon-gwangyeoksi | 21565 | South Korea |
| Investigational Site Number : 4100001 | Seoul | 01757 | South Korea |
| Investigational Site Number : 4100003 | Seoul | 02447 | South Korea |
| Investigational Site Number : 4100005 | Seoul | 05505 | South Korea |
| Investigational Site Number : 4100004 | Seoul | 06351 | South Korea |
| Investigational Site Number : 7240005 | Barcelona | Catalunya [Cataluña] | 08950 | Spain |
| Investigational Site Number : 7240012 | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Investigational Site Number : 7240009 | Mieres | Principality of Asturias | 33611 | Spain |
| Investigational Site Number : 7240011 | Barcelona | 08003 | Spain |
| Investigational Site Number : 7240002 | Barcelona | 08041 | Spain |
| Investigational Site Number : 7240003 | Madrid | 28007 | Spain |
| Investigational Site Number : 7240010 | Madrid | 28041 | Spain |
| Derived |
| Paller AS, de Bruin-Weller M, Marcoux D, Baselga E, Oliveira de Carvalho V, Ardusso LRF, Pasmans SGMA, Toledo-Bahena M, Rubin C, Joyce JC, Wine Lee L, Adams B, Gupta R, Ardeleanu M, Zhang A. Real-world treatment outcomes of systemic treatments for moderate-to-severe atopic dermatitis in children aged less than 12 years: 2-year results from PEDIatric STudy in Atopic Dermatitis. J Am Acad Dermatol. 2025 Feb;92(2):242-251. doi: 10.1016/j.jaad.2024.09.046. Epub 2024 Oct 9. |
| 32209624 | Derived | Paller AS, Guttman-Yassky E, Irvine AD, Baselga E, de Bruin-Weller M, Jayawardena S, Zhang A, Mina-Osorio P, Rizova E, Ozturk ZE. Protocol for a prospective, observational, longitudinal study in paediatric patients with moderate-to-severe atopic dermatitis (PEDISTAD): study objectives, design and methodology. BMJ Open. 2020 Mar 24;10(3):e033507. doi: 10.1136/bmjopen-2019-033507. |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided