Actively Recruiting
A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
Led by Pfizer · Updated on 2026-05-06
150
Participants Needed
41
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 confirmed by Hanifin and Rajka criteria
- Moderate-to-severe atopic dermatitis at baseline: body surface area (BSA) ≥10%, Validated Investigator's Global Assessment (vIGA) score ≥3, Eczema Area and Severity Index (EASI) ≥16, and Worst Itch Numeric Rating Scale (WI-NRS) ≥4
- History within 6 months of inadequate response to topical medical therapy for atopic dermatitis for at least 4 weeks and candidates for systemic therapy
- Body weight of at least 15 kilograms
- No contraception required for male participants
You will not qualify if you...
- Any medical or psychiatric condition including active suicidal thoughts in the past year or suicidal behavior in the past 5 years
- Strength Disorder Questionnaire (SDQ) total score ≥17 without clearance by pediatric mental health professional
- Skin infections requiring systemic antibiotics within 2 weeks prior to baseline or superficial skin infections within 1 week prior to baseline
- History of systemic infection requiring hospitalization or intravenous antibiotics within 1 month prior to baseline
- History of disseminated herpes zoster or herpes simplex, or recurrent localized dermatomal herpes zoster
- Infection with HIV, hepatitis B, or hepatitis C
- Active tuberculosis or inadequately treated latent tuberculosis
- Other skin conditions interfering with assessment such as psoriasis, seborrheic dermatitis, or lupus on Day 1
- History of skeletal dysplasia or retinal detachment
- History or conditions associated with low platelets, blood clotting problems, or platelet dysfunction
- Prior history of leukemia, lymphoma, sarcoma, or other cancers
- Immunodeficiency or first-degree relative with hereditary immunodeficiency
- Prior treatment with systemic JAK inhibitors for atopic dermatitis
- Live attenuated vaccination within 6 weeks prior to baseline or planned during treatment or within 6 weeks after last dose
- Use of strong enzyme inhibitors or inducers affecting drug metabolism during study
- Participation in another investigational drug study within 30 days or 5 half-lives before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
N
Nancy A Sherman, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here