A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema
A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
- Eczema
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 150
- Started
- 24 July 2025
- Main results due
- 2 May 2027
- Study sites
- 47
- Registry updated
- 25 September 2026
Can you take part?
- Ages 6 years to 11 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria Children aged 6 to \<12 years at the time of informed consent/assent. • No contraception methods are required for male participants. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants. Disease Characteristics: Participants who meet all of the following AD criteria: * A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria\[19\]; and * A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4); and * Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy Other Inclusion Criteria: Body weight ≥15 kg Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: Medical Conditions: Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. If the participant has SDQ total score ≥17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents. Have any of the following medical conditions: * Infections: * Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline) or have superficial skin infections within 1 week of Day 1. * History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1. * Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster. * Infection with HIV, hepatitis B, and/or hepatitis C * Evidence of active TB or inadequately treated latent TB. * Skin Conditions: \- Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment. * Other Conditions: * Documented history of skeletal dysplasia. * Documented history of retinal detachment. * History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction. * Prior history of leukemia, lymphoma, sarcoma or any other malignancy. * Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency. * Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study. Prior/Concomitant Therapy: Prior treatment with a systemic JAK inhibitor for AD. Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention. Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates is not allowed in the study. Prior/Concurrent Clinical Study Experience: Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(47)
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, United States
Recruiting
Arkansas Research Trials
North Little Rock, Arkansas, United States
Recruiting
Investigational Drug Service - Rady Childrens Hospital-San Diego
San Diego, California, United States
Recruiting
University of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent Derm
San Diego, California, United States
Recruiting
Solutions Through Advanced Research
Jacksonville, Florida, United States
Recruiting
Ada West Research
Meridian, Idaho, United States
Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Recruiting
Saint Louis University - Department of Dermatology
St Louis, Missouri, United States
Recruiting
Medical University of South Carolina - Department of Dermatology
Charleston, South Carolina, United States
Recruiting
Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
Charleston, South Carolina, United States
Recruiting
Medical University of South Carolina - Walton Research Building
Charleston, South Carolina, United States
Recruiting
Tribe Clinical Research, LLC
Greenville, South Carolina, United States
Recruiting
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Recruiting
Beijing Children's hospital, Capital Medical University
Beijing, Beijing Municipality, China
Recruiting
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
Recruiting
Hunan Children's Hospital
Changsha, Hunan, China
Recruiting
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
Recruiting
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Recruiting
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China
Recruiting
Shanghai Children's Hospital
Shanghai, China
Recruiting
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, China
Recruiting
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Recruiting
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, Germany
Recruiting
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, Hungary
Recruiting
Trial Pharma Kft.
Békéscsaba, Bekes County, Hungary
Recruiting
Szegedi Tudományegyetem Bőrgyógyászati és Allergológiai Klinika
Szeged, Csongrád-csanád, Hungary
Recruiting
Clinexpert Kft.
Budapest, Pest County, Hungary
Recruiting
University of Pecs
Pécs, Hungary
Recruiting
Queen's square Medical Facilities Queen's square Dermatology and Allergology
Yokohama, Kanagawa, Japan
Recruiting
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, Japan
Recruiting
Sasamoto Children's Clinic
Setagaya-ku, Tokyo, Japan
Recruiting
Fukuoka National Hospital
Fukuoka, Japan
Recruiting
Saruta Dermatology Clinic
Fukuoka, Japan
Recruiting
Hospital Infantil de México Federico Gómez
Mexico City, Mexico City, Mexico
Recruiting
Eukarya Pharmasite S.C.
Monterrey, Nuevo León, Mexico
Recruiting
Arke SMO S.A. de C.V.
Veracruz, Veracruz, Mexico
Recruiting
Servicios Hospitalarios de México S.A. de C.V. (Hospital Angeles Chihuahua)
Chihuahua City, Mexico
Recruiting
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka cywilna
Krakow, Lesser Poland Voivodeship, Poland
Recruiting
LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
Lublin, Lublin Voivodeship, Poland
Recruiting
Centrum Medyczne Evimed
Warsaw, Masovian Voivodeship, Poland
Recruiting
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska
Chorzów, Silesian Voivodeship, Poland
Recruiting
Centrum Medyczne Angelius Provita
Katowice, Silesian Voivodeship, Poland
Recruiting
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
Lodz, Łódź Voivodeship, Poland
Recruiting
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Recruiting
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], Spain
Recruiting
Hospital General de Granollers
Granollers, Barcelona [barcelona], Spain
Recruiting
Hospital Universitario Miguel Servet
Zaragoza, Spain
Recruiting
Showing 47 of 47 sites. 47 of the 47 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06807268. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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