Actively Recruiting
A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study of Abrocitinib in Children 6 to Less Than 12 Years With Moderate-to-Severe Atopic Dermatitis
Led by Pfizer · Updated on 2026-05-06
150
Participants Needed
41
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects and safety of abrocitinib, a test medicine, in children aged 6 to less than 12 years who have moderate-to-severe eczema. The study is designed to compare abrocitinib with a placebo, a look-alike medicine without active ingredients, to better understand how well abrocitinib works for this condition. The research will last about 24 weeks, including 16 weeks of treatment. Participants will be randomly assigned to receive either abrocitinib or placebo as a liquid oral suspension daily for 16 weeks. The study uses questionnaires and an electronic diary on a device similar to a cellphone to track eczema symptoms and remind participants to take their medicine. Children will also wear a wrist device resembling a watch to detect scratching caused by eczema. Health will be monitored with lab tests, physical exams, and vital signs throughout the study. During the study, participants will visit the clinic for assessments and receive calls from the study doctor or nurse to check on their condition. Questionnaires will help measure eczema severity and itchiness, while the wrist device tracks scratching behavior. The main outcomes measured include improvement in skin condition and itch severity by week 12. Safety and health monitoring will continue through the study, ensuring detailed observation of treatment effects and participant well-being.
CONDITIONS
Brief Title
A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to less than 12 years at the time of consent
- Documented diagnosis of chronic atopic dermatitis for at least 1 year
- Moderate-to-severe atopic dermatitis at baseline (BSA ≥10%, vIGA ≥3, EASI ≥16, WI-NRS ≥4)
- History of inadequate response to topical medical therapy for atopic dermatitis within 6 months
- Body weight of at least 15 kilograms
- Male participants have no contraception requirements as per study appendix
You will not qualify if you...
- Any medical or psychiatric condition that increases risk or is judged inappropriate by the investigator
- SDQ total score ≥17 without clearance by a pediatric mental health professional
- Skin infections requiring systemic treatment within 2 weeks or superficial infections within 1 week prior to baseline
- History of systemic infection requiring hospitalization or significant infections within 1 month prior to baseline
- History of disseminated herpes zoster or herpes simplex infections
- Infection with HIV, hepatitis B or C
- Active or inadequately treated tuberculosis
- Skin conditions like psoriasis, seborrheic dermatitis, or lupus interfering with evaluation
- History of skeletal dysplasia or retinal detachment
- History or conditions related to thrombocytopenia, coagulopathy, or platelet dysfunction
- History of leukemia, lymphoma, sarcoma, or other malignancies
- Immunodeficiency disorders or first-degree relatives with hereditary immunodeficiency
- Prior treatment with systemic JAK inhibitors for atopic dermatitis
- Live attenuated vaccinations within 6 weeks prior to baseline or planned during treatment
- Use of strong CYP2C19 and CYP2C9 enzyme inhibitors or inducers, P-gp substrates with narrow therapeutic index
- Prior investigational drug use within 30 days or 5 half-lives before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive Abrocitinib or placebo as a liquid oral suspension and complete questionnaires about their eczema using an electronic diary. They also wear a wrist device to monitor scratching and have laboratory tests, physical exams, and vital signs monitored to assess health.
Clinic visits and phone calls during the study as scheduled by the study staff
Trial Site Locations
Total: 41 locations
1
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, United States, 35244
Actively Recruiting
2
Arkansas Research Trials
North Little Rock, Arkansas, United States, 72117
Actively Recruiting
3
Investigational Drug Service - Rady Childrens Hospital-San Diego
San Diego, California, United States, 92123
Actively Recruiting
4
University of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent Derm
San Diego, California, United States, 92123
Actively Recruiting
5
Solutions Through Advanced Research
Jacksonville, Florida, United States, 32256
Actively Recruiting
6
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46250
Actively Recruiting
7
Saint Louis University - Department of Dermatology
St Louis, Missouri, United States, 63104
Actively Recruiting
8
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
9
Tribe Clinical Research, LLC
Greenville, South Carolina, United States, 29607
Actively Recruiting
10
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78235
Actively Recruiting
11
Beijing Children's hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
12
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518026
Actively Recruiting
13
Hunan Children's Hospital
Changsha, Hunan, China, 410007
Actively Recruiting
14
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China, 330000
Actively Recruiting
15
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
16
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
17
Shanghai Children's Hospital
Shanghai, China, 200062
Actively Recruiting
18
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, China, 200092
Actively Recruiting
19
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149
Not Yet Recruiting
20
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
21
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, Hungary, 7632
Actively Recruiting
22
Trial Pharma Kft.
Békéscsaba, Bekes County, Hungary, 5600
Not Yet Recruiting
23
Clinexpert Kft.
Budapest, Pest County, Hungary, 1033
Actively Recruiting
24
University of Pecs
Pécs, Hungary, 7622
Actively Recruiting
25
Queen's square Medical Facilities Queen's square Dermatology and Allergology
Yokohama, Kanagawa, Japan, 220-6208
Actively Recruiting
26
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, Japan, 593-8324
Actively Recruiting
27
Sasamoto Children's Clinic
Setagaya-ku, Tokyo, Japan, 157-0066
Actively Recruiting
28
Fukuoka National Hospital
Fukuoka, Japan, 811-1394
Actively Recruiting
29
Saruta Dermatology Clinic
Fukuoka, Japan, 819-0042
Actively Recruiting
30
Eukarya Pharmasite S.C.
Monterrey, Nuevo León, Mexico, 64718
Not Yet Recruiting
31
Arke SMO S.A. de C.V.
Veracruz, Veracruz, Mexico, 91900
Not Yet Recruiting
32
Servicios Hospitalarios de México S.A. de C.V. (Hospital Angeles Chihuahua)
Chihuahua City, Mexico, 31238
Not Yet Recruiting
33
LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
Lublin, Lublin Voivodeship, Poland, 20-573
Actively Recruiting
34
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, Poland, 02-625
Actively Recruiting
35
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska
Chorzów, Silesian Voivodeship, Poland, 41-500
Actively Recruiting
36
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland, 40-611
Actively Recruiting
37
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, Poland, 90-436
Actively Recruiting
38
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
Actively Recruiting
39
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
Actively Recruiting
40
Hospital General de Granollers
Granollers, Barcelona [barcelona], Spain, 08402
Actively Recruiting
41
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
N
Nancy A Sherman, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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