Actively Recruiting
Long-Term Study of Abrocitinib Oral Suspension With or Without Topical Medications in Children Aged 2 to 11 Years With Moderate-to-Severe Atopic Dermatitis
Led by Pfizer · Updated on 2026-04-07
500
Participants Needed
31
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and effectiveness of abrocitinib oral suspension, with or without topical medications, in children aged 2 years and older who have moderate-to-severe atopic dermatitis. This Phase 3, open-label study will include participants who have previously completed other abrocitinib studies as well as children who have never participated in such studies. The trial aims to better understand how this treatment works over a period of up to 2 years or until the medication becomes commercially available. All participants will receive abrocitinib oral suspension. The study includes two groups: an extension cohort of up to 320 children who completed previous abrocitinib studies, and a de novo cohort of approximately 180 children aged 6 to under 12 years who have not received abrocitinib before. The intervention will be given alongside topical medications as needed, and the study will monitor both safety and treatment response during this time. During the study, participants will undergo regular assessments that include monitoring for treatment-emergent adverse events, serious side effects, and reasons for discontinuation. Researchers will also measure clinical responses using tools such as the Investigator's Global Assessment, itch rating scales, eczema severity indexes, and quality of life questionnaires. Laboratory tests and vaccination responses will be tracked, and data will be collected throughout the 24-month study period to evaluate long-term effects and safety.
CONDITIONS
Brief Title
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 2 to under 12 years who completed prior abrocitinib studies (extension cohort).
- Female participants of child-bearing potential must not be pregnant or breastfeeding and must use effective contraception during and for 28 days after treatment.
- Children aged 6 to under 12 years who have not participated in prior abrocitinib studies (de novo cohort).
- Documented diagnosis of chronic atopic dermatitis for at least 6 months prior to screening.
- 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 at least 4 weeks and candidates for systemic therapy.
- Body weight of at least 15 kg.
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, or laboratory abnormalities increasing study risk.
- Use of prohibited concomitant treatments.
- Vaccination with live attenuated vaccines during treatment and for 6 weeks after.
- Ongoing adverse events or safety concerns from prior studies.
- Discontinuation from prior studies for safety reasons.
- Skin infections requiring systemic antibiotics within 2 weeks or superficial infections within 1 week prior to baseline.
- History of significant systemic infections or certain viral infections (HIV, hepatitis B or C, tuberculosis).
- Other skin conditions interfering with evaluation (e.g., psoriasis, lupus).
- History of skeletal dysplasia, retinal detachment, blood disorders, or malignancies.
- Immunodeficiency disorders or family history of hereditary immunodeficiency.
- Prior treatment with systemic JAK inhibitors for atopic dermatitis.
- Use of strong CYP2C19 and CYP2C9 enzyme inhibitors or inducers.
- Recent investigational drug use within 30 days or 5 half-lives before baseline.
- Significant liver, kidney, or blood abnormalities.
- Investigator site staff and their families or sponsor employees involved in the study.
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 - Up to 2 years or until commercial availability, whichever occurs earlier
Participants receive abrocitinib oral suspension with or without topical medications to treat moderate-to-severe atopic dermatitis.
Regular visits throughout treatment period
Trial Site Locations
Total: 31 locations
1
Cahaba Dermatology & Skin Health Center
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
Not Yet Recruiting
4
University of California, San Diego/ Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Not Yet 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
Not Yet Recruiting
7
Tribe Clinical Research, LLC
Greenville, South Carolina, United States, 29607
Actively Recruiting
8
Hunan Children's Hospital
Changsha, Hunan, China, 410007
Not Yet Recruiting
9
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China, 330000
Not Yet Recruiting
10
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
11
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, China, 200092
Actively Recruiting
12
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany, 48149
Not Yet Recruiting
13
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, Germany, 01307
Not Yet Recruiting
14
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, Hungary, 7632
Actively Recruiting
15
Clinexpert Kft.
Budapest, Pest County, Hungary, 1033
Actively Recruiting
16
Queen's square Medical Facilities Queen's square Dermatology and Allergology
Yokohama, Kanagawa, Japan, 220-6208
Actively Recruiting
17
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, Japan, 593-8324
Actively Recruiting
18
Sasamoto Children's Clinic
Setagaya-ku, Tokyo, Japan, 157-0066
Actively Recruiting
19
Fukuoka National Hospital
Fukuoka, Japan, 811-1394
Actively Recruiting
20
Eukarya Pharmasite S.C.
Monterrey, Nuevo León, Mexico, 64718
Not Yet Recruiting
21
Arké SMO S.A de C.V
Veracruz, Veracruz Ignacio de LA Llave, Mexico, 91900
Not Yet Recruiting
22
Servicios Hospitalarios de Mexico S.A. DE C.V.
Chihuahua City, Mexico, 31238
Not Yet Recruiting
23
LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
Lublin, Lublin Voivodeship, Poland, 20-573
Not Yet Recruiting
24
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, Poland, 02-625
Not Yet Recruiting
25
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska
Chorzów, Silesian Voivodeship, Poland, 41-500
Actively Recruiting
26
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland, 40-611
Not Yet Recruiting
27
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, Poland, 90-436
Not Yet Recruiting
28
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
Actively Recruiting
29
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
Not Yet Recruiting
30
Hospital General de Granollers
Granollers, Barcelona, Spain, 08402
Not Yet Recruiting
31
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Not Yet Recruiting
Research Team
P
Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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