New liquid drug offers hope for kids with severe eczema

NCT ID NCT06807281

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This 24-month study tests the long-term safety and effectiveness of abrocitinib, a liquid oral medication, in children aged 2 and older with moderate-to-severe atopic dermatitis (eczema). About 500 participants will receive the drug, with or without topical creams. The goal is to see if the drug can safely control eczema symptoms over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: abrocitinib (liquid oral suspension)
What this could lead to: If successful, this could provide a long-term treatment option for children with moderate-to-severe eczema, helping control symptoms and improve quality of life.
What could go wrong: This is an open-label study without a placebo group, so results may be less definitive. Side effects are possible, and the treatment requires ongoing use, not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Feb 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for the Extension Cohort: 1\. Participants who have completed the treatment phase of the qualifying parent study (age 2 to \<12 years old). • No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the participant is of child-bearing potential, must use a highly effective form of contraception (i.e., abstinence) during the study intervention period and for at least 28 days after the last dose of study intervention. Inclusion Criteria for the De Novo Cohort: Age 1. Children aged 6 to \<12 years at the time of informed consent/assent. • No contraception methods are required for male participants. Disease Characteristics: 2. Participants who meet all of the following AD criteria: * A documented diagnosis of chronic AD for at least 6 months prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria; 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: 3. Body weight ≥15 kg Exclusion Criteria for the Extension Cohort: Medical Conditions: 1. 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 the child or refer them 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. Prior/Concomitant Therapy: 2. Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol. 3. Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment. Diagnostic Assessments: 4. Ongoing adverse event in the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the participant is currently triggering safety monitoring criteria. 5. Discontinued from treatment early in the parent studies OR triggered a discontinuation criterion at any point during the parent studies OR meets exclusion criteria from the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern. Exclusion Criteria for the De Novo Cohort Medical Conditions: 1. 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. 2. 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: 3. Prior treatment with a systemic JAK inhibitor for AD. 4. 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. 5. Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study. Prior/Concurrent Clinical Study Experience: 6. Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1. Diagnostic Assessments: 7. Hepatic and/or renal and/or hematological abnormalities defined as: * AST \>2 x ULN * Hemoglobin \<10 g/dL * ALT \>2 x ULN * ANC \<1000/mm3 * Total bilirubin ≥1.5 x ULN * ALC \<500/mm3 * eGFR \<60 mL/min/1.73 m2 * Platelets \<150,000 /mm3 Other Exclusion Criteria: 8. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

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Conditions

The condition(s) this trial relates to.

atopic eczema Eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

41 sites in 8 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Ada West Research - Meridian
NOT_YET_RECRUITING

Meridian, Idaho, 83646, United States
Arkansas Research Trials
RECRUITING

North Little Rock, Arkansas, 72117, United States
Arké SMO S.A de C.V
NOT_YET_RECRUITING

Veracruz, Veracruz Ignacio de LA Llave, 91900, Mexico
Beijing Children's hospital, Capital Medical University
RECRUITING

Beijing, Beijing Municipality, 100045, China
CHUS - Hospital Clinico Universitario
RECRUITING

Santiago de Compostela, A Coruña [LA Coruña], 15706, Spain
Cahaba Dermatology & Skin Health Center
RECRUITING

Birmingham, Alabama, 35244, United States
Centrum Medyczne Angelius Provita
NOT_YET_RECRUITING

Katowice, Silesian Voivodeship, 40-611, Poland
Centrum Medyczne Evimed
RECRUITING

Warsaw, Masovian Voivodeship, 02-625, Poland
Clinexpert Kft.
RECRUITING

Budapest, Pest County, 1033, Hungary
DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska
RECRUITING

Chorzów, Silesian Voivodeship, 41-500, Poland
Dawes Fretzin Clinical Research Group, LLC
RECRUITING

Indianapolis, Indiana, 46250, United States
Dermatology Hospital of Jiangxi Province
NOT_YET_RECRUITING

Nanchang, Jiangxi, 330000, China
Dermatology and Ophthalmology Kume Clinic
RECRUITING

Sakai, Osaka, 593-8324, Japan
Dermedic Jacek Zdybski
RECRUITING

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
RECRUITING

Lodz, Łódź Voivodeship, 90-436, Poland
Eukarya Pharmasite S.C.
NOT_YET_RECRUITING

Monterrey, Nuevo León, 64718, Mexico
Fukuoka National Hospital
RECRUITING

Fukuoka, 811-1394, Japan
Hangzhou Third People's Hospital
RECRUITING

Hangzhou, Zhejiang, 310009, China
Hospital General de Granollers
RECRUITING

Granollers, Barcelona, 08402, Spain
Hospital Infantil de Mexico Federico Gomez
NOT_YET_RECRUITING

Mexico City, Mexico City, 06720, Mexico
Hospital Universitario Miguel Servet
RECRUITING

Zaragoza, 50009, Spain
Hunan Children's Hospital
RECRUITING

Changsha, Hunan, 410007, China
Investigational Drug Service - Rady Childrens Hospital-San Diego
NOT_YET_RECRUITING

San Diego, California, 92123, United States
LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
RECRUITING

Lublin, Lublin Voivodeship, 20-573, Poland
Medical University of South Carolina - South Carolina Translational Research Nexus Clinic
RECRUITING

Charleston, South Carolina, 29425, United States
Pécsi Tudományegyetem Klinikai Központ
RECRUITING

Pécs, Baranya, 7632, Hungary
Queen's square Medical Facilities Queen's square Dermatology and Allergology
RECRUITING

Yokohama, Kanagawa, 220-6208, Japan
Saint Louis University
RECRUITING

St Louis, Missouri, 63104, United States
Saruta Dermatology Clinic
NOT_YET_RECRUITING

Fukuoka, 819-0042, Japan
Sasamoto Children's Clinic
RECRUITING

Setagaya-ku, Tokyo, 157-0066, Japan
Servicios Hospitalarios de Mexico S.A. DE C.V.
NOT_YET_RECRUITING

Chihuahua City, 31238, Mexico
Shanghai Children's Hospital
RECRUITING

Shanghai, 200062, China
Shenzhen Children's Hospital
RECRUITING

Shenzhen, Guangdong, 518026, China
Solutions Through Advanced Research
RECRUITING

Jacksonville, Florida, 32256, United States
Texas Dermatology and Laser Specialists
NOT_YET_RECRUITING

San Antonio, Texas, 78235, United States
Trial Pharma Kft.
NOT_YET_RECRUITING

Békéscsaba, Bekes County, 5600, Hungary
Tribe Clinical Research, LLC
RECRUITING

Greenville, South Carolina, 29607, United States
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
NOT_YET_RECRUITING

Dresden, Saxony, 01307, Germany
University of California, San Diego/ Rady Children's Hospital - San Diego
NOT_YET_RECRUITING

San Diego, California, 92123, United States
Universitätsklinikum Münster
NOT_YET_RECRUITING

Münster, North Rhine-Westphalia, 48149, Germany
Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine
RECRUITING

Shanghai, 200092, China

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