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New eczema drug shows promise for kids in Late-Stage trial

NCT ID NCT06807268

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tests whether abrocitinib, a liquid medicine, can improve moderate-to-severe eczema in children aged 6 to 12. About 150 kids will be randomly assigned to receive either the drug or a placebo for 16 weeks. The goal is to see if the medicine clears the skin and reduces itching better than a dummy treatment.

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 new treatment option for children with moderate-to-severe eczema, helping to clear skin and reduce itching.
What could go wrong
This is a Phase 3 trial, but results may not confirm benefit over placebo. Side effects are possible, and the study is relatively small (150 children).

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 150 people

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

Started

Jul 2025

Expected to finish

May 2027

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

6 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 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.

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Conditions

The condition(s) this trial relates to.

atopic eczema dermatitis Eczema

As listed by the trial registrant

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

Eczema

How to take part

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

  1. The places running it

    46 sites in 8 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

    RECRUITING

    Meridian, Idaho, 83646, United States

  • Arkansas Research Trials

    RECRUITING

    North Little Rock, Arkansas, 72117, United States

  • Arke SMO S.A. de C.V.

    RECRUITING

    Veracruz, Veracruz, 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, LLC

    RECRUITING

    Birmingham, Alabama, 35244, United States

  • Centrum Medyczne Angelius Provita

    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

    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.

    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 [barcelona], 08402, Spain

  • Hospital Infantil de México Federico Gómez

    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

    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 - Department of Dermatology

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medical University of South Carolina - South Carolina Translational Research Nexus Clinic

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medical University of South Carolina - Walton Research Building

    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 - Department of Dermatology

    RECRUITING

    St Louis, Missouri, 63104, United States

  • Saruta Dermatology Clinic

    RECRUITING

    Fukuoka, 819-0042, Japan

  • Sasamoto Children's Clinic

    RECRUITING

    Setagaya-ku, Tokyo, 157-0066, Japan

  • Servicios Hospitalarios de México S.A. de C.V. (Hospital Angeles Chihuahua)

    RECRUITING

    Chihuahua City, 31238, Mexico

  • Shanghai Children's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • 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

  • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka cywilna

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-002, Poland

  • Texas Dermatology and Laser Specialists

    RECRUITING

    San Antonio, Texas, 78235, United States

  • Trial Pharma Kft.

    RECRUITING

    Békéscsaba, Bekes County, 5600, Hungary

  • Tribe Clinical Research, LLC

    RECRUITING

    Greenville, South Carolina, 29607, United States

  • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

    RECRUITING

    Dresden, Saxony, 01307, Germany

  • University of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent Derm

    RECRUITING

    San Diego, California, 92123, United States

  • University of Pecs

    RECRUITING

    Pécs, 7622, Hungary

  • Universitätsklinikum Münster

    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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