A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
Start Date
7/24/2025
Completion Date
5/2/2027
Summary
This research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to \<12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total.
Detailed Description
Different questionnaires will be used to find out how the participant's eczema is doing during the research study. An electronic diary, which looks like a cellular phone, will be used to collect the questionnaire information and other research study-related information. It will also be used to remind participants to take the test medicine each day and to fill out the questionnaires. Participants will also be asked to wear something on their wrist that looks like a children's wristwatch so we can know when they are scratching their skin because of their atopic dermatitis. Laboratory tests, physical examinations and vital signs (height, weight, temperature, blood pressure and heart rate) will be conducted before and during the research study to monitor your child's health. Participants will need to come to the clinic for research study visits and at other times during the research study, the research study doctor or nurse will call the participants to find out the participant is doing.
Eligibility Criteria
Age Range: 6 years to 11 years
Interventions
Abrocitinib
Placebo
Conditions
Locations
Cahaba Dermatology & Skin Health Center, LLC
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; Pediatric & Adolescent Derm
San Diego, California 92123
United States
Solutions Through Advanced Research
Jacksonville, Florida 32256
United States
Ada West Research
Meridian, Idaho 83646
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana 46250
United States
Saint Louis University - Department of Dermatology
St Louis, Missouri 63104
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
Shanghai Children's Hospital
Shanghai, Shanghai Municipality 200040
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
Trial Pharma Kft.
Békéscsaba, Bekes County 5600
Hungary
Clinexpert Kft.
Budapest, Pest County 1033
Hungary
University of Pecs
Pécs, 7622
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
Arke SMO S.A. de C.V.
Veracruz, Veracruz 91900
Mexico
Servicios Hospitalarios de México S.A. de C.V. (Hospital Angeles Chihuahua)
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 [barcelona] 08402
Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009
Spain