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Atopic DermatitisPhase 3NCT06807281

A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema

A Phase 3 study testing Abrocitinib in people with Atopic Dermatitis, run by Pfizer at 39 sites in 7 countries.

Recruiting

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

Sites and contacts
Official record
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Trial summary

This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. Read more about this study

Who is it for?
Ages 2 to 11 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Abrocitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
39 sitesin 7 countries
Study dates
2 Dec 2025to 22 Feb 2032
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 2 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
  • Age
  • Children aged 6 to <12 years at the time of informed consent/assent.
  • No contraception methods are required for male participants.
  • Disease Characteristics:
Show all 12Show fewer
  • 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:
  • Body weight ≥15 kg

Who cannot join

  • 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 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:
  • Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.
  • Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment.
Show all 46Show fewer
  • Diagnostic Assessments:
  • 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.
  • 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.
  • 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 and strong inducers of CYP2C9 enzymes 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.
  • Diagnostic Assessments:
  • 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:
  • 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.

Trial locations and contacts

39 sites in 7 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

39 sites in 7 countries

United States11 sites, 11 recruiting

  • Cahaba Dermatology & Skin Health Center

    Birmingham, Alabama, 35244

    Recruiting

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

    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

    Meridian, Idaho, 83646

    Not yet recruiting

  • Arkansas Research Trials

    North Little Rock, Arkansas, 72117

    Recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78235

    Not yet recruiting

  • Investigational Drug Service - Rady Childrens Hospital-San Diego

    San Diego, California, 92123

    Not yet recruiting

  • University of California, San Diego/ Rady Children's Hospital - San Diego

    San Diego, California, 92123

    Not yet recruiting

  • Saint Louis University

    St Louis, Missouri, 63104

    Recruiting

Other trials in United States

China7 sites, 7 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

    Not yet 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

Poland6 sites, 6 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

    Not yet 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

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 Mexico S.A. DE C.V.

    Chihuahua City, 31238

    Not yet recruiting

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, Mexico City, 06720

    Not yet recruiting

  • Eukarya Pharmasite S.C.

    Monterrey, Nuevo León, 64718

    Not yet recruiting

  • Arké SMO S.A de C.V

    Veracruz, Veracruz Ignacio de LA Llave, 91900

    Not yet recruiting

Other trials in Mexico

Hungary3 sites, 3 recruiting

  • Trial Pharma Kft.

    Békéscsaba, Bekes County, 5600

    Recruiting

  • Clinexpert Kft.

    Budapest, Pest County, 1033

    Recruiting

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya, 7632

    Recruiting

Other trials in Hungary

Spain3 sites, 3 recruiting

  • Hospital General de Granollers

    Granollers, 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

About this study

Official title: A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic Dermatitis

This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.

Read the detailed description

Phase 3, open-label study to assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children ≥2 years of age with moderate-to-severe atopic dermatitis (AD). This study will enroll participants in two cohorts: an extension cohort of participants who previously completed prior abrocitinib studies, and a de novo cohort of participants (6 to <12 years of age) who have not participated in previous abrocitinib studies. Study duration will be up to 2 years (or commercial availability, whichever occurs earlier). The study will enroll a maximum of approximately 500 participants with moderate-to-severe Atopic Dermatitis from study sites globally (extension cohort will enroll up to 320 participants; de novo cohort will enroll approximately 180 participants). All participants will receive the study intervention abrocitinib oral suspension.

Being tested
Abrocitinib
Keywords
eczema, atopic dermatitis
Medical subject headings
Dermatitis, Atopic, Eczema

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.

Study groups in NCT06807281
Study groupRoleWhat they receive
ExtensionExperimentalPatients who have completed other abrocitinib studies
Receives: Drug: Abrocitinib
De novoExperimentalPatients who have not participated other abrocitinib studies
Receives: Drug: Abrocitinib

What is being measured

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

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation

    The number of the treatment emergent adverse events, serious adverse events and adverse events leading to discontinuation among patients with moderate-to-severe disease treated with abrocitinib regardless of discontinuation from study treatment.

    Measured: 0-24 months

Secondary outcomes (17)

  1. Number of Participants With Clinically Significant Laboratory Abnormalities

    The number of clinically significant laboratory abnormalities among participants with moderate-to-severe disease treated with abrocitinib.

    Measured: 0-24 months

  2. 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 2 -point reduction from baseline at all scheduled time points

    Proportion of responders based on vIGA at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib

    Measured: Baseline, 24 months

  3. Percentage of Response based on achieving a ≥4 point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at all scheduled time points in participants aged ≥2 to <6 years

    Percentage of responders based on achieving an improvement ≥4 points from baseline at all scheduled time points in the WI-NRS (in patients aged ≥2 to <6 years) with moderate-to-severe disease treated with abrocitinib.

    Measured: 0-24 months

  4. Percentage of Response based on achieving a ≥4-point improvement from baseline in the WSI-NRS at all scheduled time points in participants aged ≥6 to 12 years

    Percentage of responders based on achieving an improvement ≥4 points from baseline at all scheduled time points in the WSI-NRS (in patients aged ≥6 to 12 years) with moderate-to-severe disease treated with abrocitinib.

    Measured: 0-24 months

  5. Percentage of Responders based on achieving Eczema Area and Severity Index (EASI)-50, EASI-90 and EASI-100 at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib

    Percentage of response based on achieving ≥50%, ≥90%, 100% improvement from parent study baseline in the EASI total score (EASI-50, EASI-90, EASI-100) at all scheduled time points.

    Measured: 0-24 months

  6. Percent Change from Baseline (CFB) in EASI total score at all scheduled time points.

    Mean percent CFB in EASI total score at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib

    Measured: 0-24 months

  7. Percentage of Participants with Flares

    Percentage of participants reporting flares in patients with moderate-to-severe disease treated with abrocitinib.

    Measured: 0-24 months

  8. CFB in the percentage Body Surface Area (BSA) affected at all scheduled time points

    Mean CFB in BSA affected at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib.

    Measured: 0-24 months

  9. CFB in Children's Dermatology Life Quality Index (CDLQI) at all scheduled time points.

    Mean CFB in CDLQI at all scheduled time points in participants aged ≥4 to <16 years with moderate-to-severe disease treated with abrocitinib.

    Measured: 0-24 months

  10. CFB in in Infants' Dermatitis Quality of Life (IDQOL) Index at all scheduled time points

    Mean CFB in IDQOL Index or CDQLI depending on age at all scheduled time points in participants aged <4 years with moderate-to-severe disease treated with abrocitinib

    Measured: 0-24 months

  11. CFB in Patient-Oriented Eczema Measure (POEM) at all scheduled time points

    Mean CFB in POEM at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib.

    Measured: 0-24 months

  12. CFB in Dermatitis Family Impact (DFI) at all scheduled time points

    Mean CFB in DFI at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib.

    Measured: 0-24 months

  13. CFB in Patient Global Impression of Severity (PGIS) at all scheduled time points

    Mean CFB in PGIS (in patients aged 6 to <12 years) at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib.

    Measured: 0-24 months

  14. CFB in Observer Reported Global Impression of Severity (OGIS) at all scheduled time points

    Mean CFB in OGIS (in patients aged 2 to <6 years) at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib

    Measured: 0-24 months

  15. CFB in the the EuroQol- 5 Dimension Youth (EQ-5D-Y)

    Mean CFB in EQ-5D-Y at all scheduled time points in patients with moderate-tosevere AD treated with abrocitinib versus placebo.

    Measured: 0-24 months

  16. Number of topical corticosteroid and /or topical calcineurin inhibitor free days

    Mean number of days free from topical corticosteroids and /or topical calcineurin inhibitor use in patients with moderate-to-severe disease treated with abrocitinib.

    Measured: 0-24 months

  17. Percentage of Participants Achieving satisfactory response in Tdap/DTaP and/or pneumococcal antibody titers as appropriate in participants who receive Tdap/DTaP and/or pneumococcal vaccinations

    For patients that receive Tdap/ DTap and/or pneumococcal vaccinations during the study, the proportion of patients treated with abrocitinib who achieve satisfactory immunogenicity at 4 weeks after receiving the vaccinations.

    Measured: 0-24 months

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 start2 Dec 2025
  3. Primary completion22 Feb 2032 (estimated)
  4. Study completion22 Feb 2032 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06807281
Sponsor's protocol ID
B7451031
Other IDs
2023-509124-18-00, 2023
Status last verified
Oct 2026
First submitted
29 Jan 2025
Last updated
13 Oct 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 Atopic Dermatitis, run by Pfizer at 39 sites in 7 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 12 inclusion and 46 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, China, Poland, Japan, Mexico and 2 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. 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?

Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation (time frame: 0-24 months). 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 NCT06807281.

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 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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