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EczemaPhase 3NCT06807268

A Study of the Medicine Called Abrocitinib in Children 6 to Less Than 12 Years of Age With Moderate-to-Severe Eczema

A Phase 3 study testing Abrocitinib in people with Eczema, run by Pfizer at 47 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 11 years
Conditions the study is for
Eczema
What is being tested?
Abrocitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
47 sitesin 8 countries
Study dates
24 Jul 2025to 2 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

None listed.

Who cannot join

  • 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:
Show all 25Show fewer
  • 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.

Trial locations and contacts

47 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Nancy A Sherman, BA contact

2127332323

Nancy.Sherman@Pfizer.com

47 sites in 8 countries

United States13 sites, 13 recruiting

  • Cahaba Dermatology & Skin Health Center, LLC

    Birmingham, Alabama, 35244

    Recruiting

  • Medical University of South Carolina - Department of Dermatology

    Charleston, South Carolina, 29425

    Recruiting

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

    Charleston, South Carolina, 29425

    Recruiting

  • Medical University of South Carolina - Walton Research Building

    Charleston, South Carolina, 29425

    Recruiting

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

    Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

    Recruiting

  • Solutions Through Advanced Research

    Jacksonville, Florida, 32256

    Recruiting

  • Ada West Research

    Meridian, Idaho, 83646

    Recruiting

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72117

    Recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78235

    Recruiting

  • Investigational Drug Service - Rady Childrens Hospital-San Diego

    San Diego, California, 92123

    Recruiting

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

    San Diego, California, 92123

    Recruiting

  • Saint Louis University - Department of Dermatology

    St Louis, Missouri, 63104

    Recruiting

Other trials in United States

China8 sites, 8 recruiting

  • Beijing Children's hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045

    Recruiting

  • Hunan Children's Hospital

    Changsha, Hunan, 410007

    Recruiting

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang, 310009

    Recruiting

  • Dermatology Hospital of Jiangxi Province

    Nanchang, Jiangxi, 330000

    Recruiting

  • Shanghai Children's Hospital

    Shanghai, Shanghai Municipality, 200040

    Recruiting

  • Shanghai Children's Hospital

    Shanghai, 200062

    Recruiting

  • Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine

    Shanghai, 200092

    Recruiting

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong, 518026

    Recruiting

Other trials in China

Poland7 sites, 7 recruiting

  • DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska

    Chorzów, Silesian Voivodeship, 41-500

    Recruiting

  • Centrum Medyczne Angelius Provita

    Katowice, Silesian Voivodeship, 40-611

    Recruiting

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

    Krakow, Lesser Poland Voivodeship, 30-002

    Recruiting

  • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak

    Lodz, Łódź Voivodeship, 90-436

    Recruiting

  • LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska

    Lublin, Lublin Voivodeship, 20-573

    Recruiting

  • Dermedic Jacek Zdybski

    Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400

    Recruiting

  • Centrum Medyczne Evimed

    Warsaw, Masovian Voivodeship, 02-625

    Recruiting

Other trials in Poland

Hungary5 sites, 5 recruiting

  • Trial Pharma Kft.

    Békéscsaba, Bekes County, 5600

    Recruiting

  • Clinexpert Kft.

    Budapest, Pest County, 1033

    Recruiting

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya, 7632

    Recruiting

  • University of Pecs

    Pécs, 7622

    Recruiting

  • Szegedi Tudományegyetem Bőrgyógyászati és Allergológiai Klinika

    Szeged, Csongrád-csanád, 6720

    Recruiting

Other trials in Hungary

Japan5 sites, 5 recruiting

  • Fukuoka National Hospital

    Fukuoka, 811-1394

    Recruiting

  • Saruta Dermatology Clinic

    Fukuoka, 819-0042

    Recruiting

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, Osaka, 593-8324

    Recruiting

  • Sasamoto Children's Clinic

    Setagaya-ku, Tokyo, 157-0066

    Recruiting

  • Queen's square Medical Facilities Queen's square Dermatology and Allergology

    Yokohama, Kanagawa, 220-6208

    Recruiting

Other trials in Japan

Mexico4 sites, 4 recruiting

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

    Chihuahua City, 31238

    Recruiting

  • Hospital Infantil de México Federico Gómez

    Mexico City, Mexico City, 06720

    Recruiting

  • Eukarya Pharmasite S.C.

    Monterrey, Nuevo León, 64718

    Recruiting

  • Arke SMO S.A. de C.V.

    Veracruz, Veracruz, 91900

    Recruiting

Other trials in Mexico

Spain3 sites, 3 recruiting

  • Hospital General de Granollers

    Granollers, Barcelona [barcelona], 08402

    Recruiting

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, A Coruña [LA Coruña], 15706

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    Recruiting

Other trials in Spain

Germany2 sites, 2 recruiting

  • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

    Dresden, Saxony, 01307

    Recruiting

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

    Recruiting

Other trials in Germany

About this study

Official title: 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

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.

Read the detailed description

Different questionnaires will be used to find out how the participant's eczema is doing during the research study. An electronic diary, which looks like a cellular phone, will be used to collect the questionnaire information and other research study-related information. It will also be used to remind participants to take the test medicine each day and to fill out the questionnaires. Participants will also be asked to wear something on their wrist that looks like a children's wristwatch so we can know when they are scratching their skin because of their atopic dermatitis. Laboratory tests, physical examinations and vital signs (height, weight, temperature, blood pressure and heart rate) will be conducted before and during the research study to monitor your child's health. Participants will need to come to the clinic for research study visits and at other times during the research study, the research study doctor or nurse will call the participants to find out the participant is doing.

Conditions
Eczema
Being tested
Abrocitinib, Placebo
Keywords
Dermatitis
Medical subject headings
Eczema, Dermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbrocitinibDrug

    Also called PF-04965842

    Abrocitinib administered as liquid oral suspension.

  • PlaceboOther

    Placebo administered as liquid oral suspension.

Study groups in NCT06807268
Study groupRoleWhat they receive
AbrocitinibExperimentalAbrocitinib administered as liquid oral suspension.
Receives: Drug: Abrocitinib
Matching PlaceboPlacebo comparatorPlacebo administered as liquid oral suspension.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12

    The difference in proportion of responders based on vIGA at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo

    Measured: At week 12

  2. Response based on achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI)-75 at Week 12

    The difference in proportion of responders based on EASI-75 at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo

    Measured: At week 12

Secondary outcomes (3)

  1. Change from Baseline (CFB) in the Worst Itch Numerical Rating Scale (WI-NRS) at Week 2

    The difference in mean CFB in WI-NRS total score at Week 2 in patients with moderate-to-severe AD treated with abrocitinib versus placebo

    Measured: At week 2

  2. Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12

    The difference in proportion of responders based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo

    Measured: At week 12

  3. Response based on achieving WI-NRS <2 at Week 12

    The difference in proportion of responders based on achieving WI-NRS <2 at Week 12 in patients with moderate-to-severe AD treated with abrocitinib versus placebo

    Measured: At week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start24 Jul 2025
  3. Primary completion2 May 2027 (estimated)
  4. Study completion2 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06807268
Sponsor's protocol ID
B7451023
Other IDs
2023-509121-51-00, 2023
Status last verified
Sep 2026
First submitted
29 Jan 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abrocitinib in people with Eczema, run by Pfizer at 47 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, China, Poland, Hungary, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response based on achieving Validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12 (time frame: At week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06807268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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