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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03687359
Other study ID # OBS15333
Secondary ID U1111-1211-9437
Status Recruiting
Phase
First received
Last updated
Start date August 15, 2019
Est. completion date April 21, 2036

Study information

Verified date December 2023
Source Sanofi
Contact Trial Transparency email recommended (Toll free number for US &
Phone 800-633-1610
Email Contact-US@sanofi.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Primary Objectives: - To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable. - To evaluate the time-course of AD and selected atopic comorbidities. Secondary Objectives: - To characterize disease burden and unmet need. - To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching). - To document the real-world effectiveness and safety of treatments.


Description:

The study duration is 60 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 1856
Est. completion date April 21, 2036
Est. primary completion date April 21, 2036
Accepts healthy volunteers No
Gender All
Age group 0 Years to 11 Years
Eligibility Inclusion criteria: - Patients with moderate to severe AD, according to the Investigator's assessment; - Currently receiving systemic treatment (including phototherapy) for atopic dermatitis or currently on topical treatment, but otherwise candidates for systemic treatment. Exclusion criteria: - Concurrent participation in an interventional clinical trial which modifies patient care. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Standard of care
Treatment as per standard practice

Locations

Country Name City State
Argentina Investigational Site Number : 0320003 Buenos Aires
Argentina Investigational Site Number : 0320001 Ciudad Autonoma Bs As
Argentina Investigational Site Number : 0320005 Ciudad Autonoma Buenos Aires
Argentina Investigational Site Number : 0320006 Ciudad Autonoma de Buenos Aire Buenos Aires
Argentina Investigational Site Number : 0320002 Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Investigational Site Number : 0320004 Rosario Santa Fe
Argentina Investigational Site Number : 0320007 San Miguel de Tucuman
Australia Investigational Site Number : 0360010 Box Hill Victoria
Australia Investigational Site Number : 0360009 Campbelltown New South Wales
Australia Investigational Site Number : 0360004 Fremantle Western Australia
Australia Investigational Site Number : 0360008 Kogarah New South Wales
Australia Investigational Site Number : 0360003 Parkville Victoria
Australia Investigational Site Number : 0360007 Richmond Victoria
Australia Investigational Site Number : 0360001 Westmead New South Wales
Brazil HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760004 Curitiba Paraná
Brazil HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná Site Number : 0760005 Curitiba Paraná
Brazil Universidade Federal do Paraná Site Number : 0760003 Curitiba Paraná
Brazil Irmandade da Santa Casa de Misericórdia de Porto Alegre Site Number : 0760002 Porto Alegre Rio Grande Do Sul
Brazil Hospital Sao Paulo Site Number : 0760006 São Paulo São Paulo
Brazil Clínica de Alergia Martti Antila Site Number : 0760001 Sorocaba
Canada Investigational Site Number : 1240004 Calgary Alberta
Canada Investigational Site Number : 1240007 Calgary Alberta
Canada Investigational Site Number : 1240001 Markham Ontario
Canada Investigational Site Number : 1240006 Montreal Quebec
Canada Investigational Site Number : 1240009 Regina Saskatchewan
Canada Investigational Site Number : 1240008 Toronto Ontario
Canada Investigational Site Number : 1240005 Winnipeg Manitoba
China Investigational Site Number : 1560004 Beijing
China Investigational Site Number : 1560006 Changsha
China Investigational Site Number : 1560001 Chongqing
China Investigational Site Number : 1560012 Guangzhou
China Investigational Site Number : 1560007 Harbin
China Investigational Site Number : 1560003 Kunming
China Investigational Site Number : 1560011 Shenzhen
China Investigational Site Number : 1560002 Suzhou
China Investigational Site Number : 1560008 Xuzhou
Colombia Investigational Site Number : 1700006 Barranquilla
Colombia Investigational Site Number : 1700001 Bogota
Colombia Investigational Site Number : 1700004 Bogota
Colombia Investigational Site Number : 1700007 Bogota
Denmark Investigational Site Number : 2080002 Kobenhavn Nv
France Investigational Site Number : 2500008 Argenteuil Cedex
France Investigational Site Number : 2500001 Bordeaux
France Investigational Site Number : 2500010 Lille cedex
France Investigational Site Number : 2500006 Marseille cedex 5
France Investigational Site Number : 2500005 Martigues
France Investigational Site Number : 2500002 Nantes Cedex 1
France Investigational Site Number : 2500003 Paris Cedex 15
France Investigational Site Number : 2500004 Saint-Etienne Cedex 2
Greece Investigational Site Number : 3000001 Athens
Greece Investigational Site Number : 3000004 Larissa
Greece Investigational Site Number : 3000002 Thessaloniki
Greece Investigational Site Number : 3000003 Thessaloniki
Israel Investigational Site Number : 3760003 Beer Sheva
Israel Investigational Site Number : 3760004 Haifa
Israel Investigational Site Number : 3760005 Kfar-Saba
Israel Investigational Site Number : 3760001 Ramat Gan
Israel Investigational Site Number : 3760002 Rehovot
Italy Investigational Site Number : 3800012 Bari
Italy Investigational Site Number : 3800003 Bologna
Italy Investigational Site Number : 3800010 Catania
Italy Investigational Site Number : 3800001 Milano
Italy Investigational Site Number : 3800008 Naples Napoli
Italy Investigational Site Number : 3800005 Napoli
Italy Investigational Site Number : 3800011 Padova
Italy Investigational Site Number : 3800006 Padua Veneto
Italy Investigational Site Number : 3800009 Perugia
Italy Investigational Site Number : 3800004 Terracina Latina
Italy Investigational Site Number : 3800007 Trieste
Japan Investigational Site Number : 3920011 Fuchu-shi Tokyo
Japan Investigational Site Number : 3920018 Fukuoka-shi
Japan Investigational Site Number : 3920017 Fukuyama-shi
Japan Investigational Site Number : 3920003 Habikino-shi Osaka-Fu
Japan Investigational Site Number : 3920002 Hiroshima-shi Hiroshima
Japan Investigational Site Number : 3920015 Kumagaya-shi
Japan Investigational Site Number : 3920004 Kyoto-shi
Japan Investigational Site Number : 3920012 Nagasaki-shi Nagasaki
Japan Investigational Site Number : 3920020 Nagoya-shi
Japan Investigational Site Number : 3920008 Obu-shi
Japan Investigational Site Number : 3920005 Osakasayama-shi
Japan Investigational Site Number : 3920009 Sagamihara-shi Kanagawa
Japan Investigational Site Number : 3920014 Sendai-shi
Japan Investigational Site Number : 3920019 Sendai-shi
Japan Investigational Site Number : 3920001 Setagaya-ku Tokyo
Japan Investigational Site Number : 3920010 Tsu-shi
Japan Investigational Site Number : 3920016 Yokohama-Shi Kanagawa
Korea, Republic of Investigational Site Number : 4100008 Ansan-si Gyeonggi-do
Korea, Republic of Investigational Site Number : 4100001 Gumi-city Gyeongsangbuk-do
Korea, Republic of Investigational Site Number : 4100007 Incheon Gyeonggi-do
Korea, Republic of Investigational Site Number : 4100003 Seoul
Korea, Republic of Investigational Site Number : 4100004 Seoul
Korea, Republic of Investigational Site Number : 4100005 Seoul
Korea, Republic of Investigational Site Number : 4100002 Suwon Gyeonggi-do
Mexico Investigational Site Number : 4840001 Mexico
Mexico Investigational Site Number : 4840006 Mexico
Mexico Investigational Site Number : 4840003 Monterrey Nuevo León
Mexico Investigational Site Number : 4840004 Puebla
Mexico Investigational Site Number : 4840005 Tlalnepantla
Netherlands Investigational Site Number : 5280001 Amsterdam
Netherlands Investigational Site Number : 5280006 Den Haag
Netherlands Investigational Site Number : 5280005 Groningen
Netherlands Investigational Site Number : 5280002 Rotterdam
Netherlands Investigational Site Number : 5280003 Utrecht
Norway Investigational Site Number : 5780001 Bergen
Norway Investigational Site Number : 5780002 Oslo
Portugal Investigational Site Number : 6200003 Braga
Portugal Investigational Site Number : 6200001 Lisboa
Portugal Investigational Site Number : 6200005 Lisboa
Russian Federation Investigational Site Number : 6430001 Moscow
Russian Federation Investigational Site Number : 6430002 Moscow
Russian Federation Investigational Site Number : 6430003 Moscow
Russian Federation Investigational Site Number : 6430004 Moscow
Russian Federation Investigational Site Number : 6430005 Moscow
Spain Investigational Site Number : 7240001 Alicante
Spain Investigational Site Number : 7240002 Barcelona
Spain Investigational Site Number : 7240005 Barcelona Catalunya [Cataluña]
Spain Investigational Site Number : 7240008 Comunidad Valenciana Valencia
Spain Investigational Site Number : 7240003 Madrid
Spain Investigational Site Number : 7240009 Santullano De Mieres Asturias
United States Georgia Pollens Clinical Research Centers, Inc. Site Number : 8400057 Albany Georgia
United States Amarillo Center for Clinical Research Site Number : 8400055 Amarillo Texas
United States Orange County Research Institute Site Number : 8400028 Anaheim California
United States Allervie Clinical Research Site Number : 8400012 Birmingham Alabama
United States C Squared Research Center Site Number : 8400068 Birmingham Alabama
United States Cahaba Dermatology Site Number : 8400046 Birmingham Alabama
United States Daxia Trials Site Number : 8400082 Boca Raton Florida
United States Philip Fried, M.D., PLLC Site Number : 8400029 Bronx New York
United States Tiga Pediatrics, PC Site Number : 8400037 Bronx New York
United States Immunoe Research Centers Site Number : 8400026 Centennial Colorado
United States UNC Hospitals Site Number : 8400016 Chapel Hill North Carolina
United States MUSC Site Number : 8400013 Charleston South Carolina
United States Northwestern University Feinberg School of Medicine Site Number : 8400001 Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Site Number : 8400017 Cincinnati Ohio
United States Centricity Research Talbotton - DBA IACT Health Research at Talbotton Site Number : 8400056 Columbus Georgia
United States Pediatric Center Of Excellence Site Number : 8400072 Coral Gables Florida
United States Green Dermatology and Cosmetic Center. Site Number : 8400078 Deerfield Beach Florida
United States 2G Clinical Research Services Site Number : 8400031 Durham North Carolina
United States Clinical Research of Gastonia Site Number : 8400041 Gastonia North Carolina
United States Pediatric Dermatology of North Texas Site Number : 8400003 Grapevine Texas
United States Allergic Disease and Asthma Research Center, PA Site Number : 8400048 Greenville South Carolina
United States Cyn3rgy Research & Development Site Number : 8400023 Gresham Oregon
United States Amedica Research Institute, Inc. Site Number : 8400067 Hialeah Florida
United States Eastern Research, Inc. Site Number : 8400032 Hialeah Florida
United States Heights Dermatology and Aesthetic Center Site Number : 8400065 Houston Texas
United States Tokunbo T. Dada, MD PA Site Number : 8400079 Irvington New Jersey
United States Children's Mercy Hospital and Clinics Site Number : 8400020 Kansas City Missouri
United States Viable Research Management Site Number : 8400027 Las Vegas Nevada
United States Michael W. Simon, M.D., PSC Site Number : 8400073 Lexington Kentucky
United States Axis Clinical Trials Site Number : 8400025 Los Angeles California
United States Family Allergy and Asthma Research Site Number : 8400060 Louisville Kentucky
United States Madera Family Medical Group Site Number : 8400054 Madera California
United States Dermatology Associates of Mid-Ohio Site Number : 8400052 Marion Ohio
United States The Dermatology Institute of South Texas Site Number : 8400076 McAllen Texas
United States Ciocca, Giovanna Site Number : 8400018 Miami Florida
United States Premier Dermatology Partners Site Number : 8400075 Miami Florida
United States Vista Health Research, LLC Site Number : 8400034 Miami Florida
United States Medical College Of Wisconsin Site Number : 8400008 Milwaukee Wisconsin
United States C2 Research Center, LLC Site Number : 8400071 Montgomery Alabama
United States Family Pediatrics Iwuozo L Obilo Md Site Number : 8400077 Newark New Jersey
United States Providence Medical Center Site Number : 8400081 North Plainfield New Jersey
United States Pediatric & Adult Research Center Site Number : 8400040 Orlando Florida
United States Phoenix Children's Hospital, Inc. Site Number : 8400015 Phoenix Arizona
United States The Indiana Clinical Trials Center, PC Site Number : 8400007 Plainfield Indiana
United States AIM Trials Site Number : 8400035 Plano Texas
United States Dermatology Associates PC Site Number : 8400049 Rockville Maryland
United States NorthShore University HealthSystem Site Number : 8400064 Skokie Illinois
United States VAMA Medical Health Center Site Number : 8400083 Union New Jersey
United States Carey Chronis, MD, FAAP Site Number : 8400033 Ventura California
United States Michigan Dermatology Institute Site Number : 8400059 Waterford Michigan

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  China,  Colombia,  Denmark,  France,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Portugal,  Russian Federation,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Demographics Age, sex, race, ethnicity, body weight and height Baseline
Primary Age at AD onset Age of study patients at time of AD onset Baseline
Primary Time from AD onset to initiation of therapy Duration from onset of AD to start of AD therapy Baseline
Primary Type of current AD therapy Type of therapy administered to treat AD (e.g., systemic, topical, other) Baseline
Primary Presence of AD and selected comorbid conditions Percentage of patients with AD and selected comorbidities (e.g., asthma and allergic rhinitis) at baseline and during study Baseline to Month 60
Secondary Percentage of patients using specific AD therapies and initiating new therapies Percentage of patients using specific AD therapies and initiating new therapies Baseline to Month 60
Secondary Eczema Area and Severity Index (EASI) EASI score as assessed by physician Baseline to Month 60
Secondary Body Surface Area (BSA) percentage affected by AD BSA score as assessed by physician Baseline to Month 60
Secondary Patient Oriented Eczema Measure (POEM) questionnaire POEM score as reported by the participant's caregiver Baseline to Month 60
Secondary Children's Dermatology Life Quality Index (CDLQI) CDLQI score as reported by the participant Baseline to Month 60
Secondary Infant's Dermatitis Quality of Life (IDQOL) IDQOL score as reported by the participant's caregiver Baseline to Month 60
Secondary Dermatitis Family Impact (DFI) questionnaires DFI score as reported by the participant's caregiver Baseline to Month 60
Secondary Peak Pruritus Numerical Rating Scale (NRS) Peak Pruritus NRS score as reported by the participant Baseline to Month 60
Secondary Worst scratching NRS questionnaires Worst scratching NRS score as reported by the participant's caregiver Baseline to Month 60
Secondary Caregiver Global Assessment of Disease (CGAD) questionnaire CGAD score as reported by the participant's caregiver Baseline to Month 60
Secondary Total Nasal Symptom Score (TNSS) questionnaire TNSS score as reported by the participant's caregiver Baseline to Month 60
Secondary Days missed from school for the patient and days missed from work for the primary caregiver due to AD Days missed from school for the patient and days missed from work for the primary caregiver due to AD Baseline to Month 60
Secondary Number of visits to healthcare professionals Number of visits to healthcare professionals for evaluation of healthcare utilization Baseline to Month 60
Secondary Incidence of adverse events Frequency of patients with at least one event, the number of events, and the incidence rate will be summarized by System Organ Class and Preferred Term Baseline to Month 60
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