A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Start Date
12/2/2025
Completion Date
2/22/2032
Summary
This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.
Detailed Description
Phase 3, open-label study to assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children ≥2 years of age with moderate-to-severe atopic dermatitis (AD). This study will enroll participants in two cohorts: an extension cohort of participants who previously completed prior abrocitinib studies, and a de novo cohort of participants (6 to \<12 years of age) who have not participated in previous abrocitinib studies. Study duration will be up to 2 years (or commercial availability, whichever occurs earlier). The study will enroll a maximum of approximately 500 participants with moderate-to-severe Atopic Dermatitis from study sites globally (extension cohort will enroll up to 320 participants; de novo cohort will enroll approximately 180 participants). All participants will receive the study intervention abrocitinib oral suspension.
Eligibility Criteria
Age Range: 2 years to 11 years
Interventions
Abrocitinib
Conditions
Locations
Cahaba Dermatology & Skin Health Center
Birmingham, Alabama 35244
United States
Arkansas Research Trials
North Little Rock, Arkansas 72117
United States
Investigational Drug Service - Rady Childrens Hospital-San Diego
San Diego, California 92123
United States
University of California, San Diego/ Rady Children's Hospital - San Diego
San Diego, California 92123
United States
Solutions Through Advanced Research
Jacksonville, Florida 32256
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Tribe Clinical Research, LLC
Greenville, South Carolina 29607
United States
Texas Dermatology and Laser Specialists
San Antonio, Texas 78235
United States
Beijing Children's hospital, Capital Medical University
Beijing, Beijing Municipality 100045
China
Shenzhen Children's Hospital
Shenzhen, Guangdong 518026
China
Hunan Children's Hospital
Changsha, Hunan 410007
China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi 330000
China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang 310009
China
Shanghai Children's Hospital
Shanghai, 200062
China
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, 200092
China
Universitätsklinikum Münster
Münster, North Rhine-Westphalia 48149
Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony 01307
Germany
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya 7632
Hungary
Clinexpert Kft.
Budapest, Pest County 1033
Hungary
Queen's square Medical Facilities Queen's square Dermatology and Allergology
Yokohama, Kanagawa 220-6208
Japan
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka 593-8324
Japan
Sasamoto Children's Clinic
Setagaya-ku, Tokyo 157-0066
Japan
Fukuoka National Hospital
Fukuoka, 811-1394
Japan
Saruta Dermatology Clinic
Fukuoka, 819-0042
Japan
Eukarya Pharmasite S.C.
Monterrey, Nuevo León 64718
Mexico
Arké SMO S.A de C.V
Veracruz, Veracruz Ignacio de LA Llave 91900
Mexico
Servicios Hospitalarios de Mexico S.A. DE C.V.
Chihuahua City, 31238
Mexico
LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
Lublin, Lublin Voivodeship 20-573
Poland
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship 02-625
Poland
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska
Chorzów, Silesian Voivodeship 41-500
Poland
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship 40-611
Poland
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship 90-436
Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship 27-400
Poland
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña] 15706
Spain
Hospital General de Granollers
Granollers, Barcelona 08402
Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009
Spain