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

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Abrocitinib

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• China
  • Shanghai, China, 200092
    • Recruiting
    • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Hunan
    • Changsha, Hunan, China, 410007
      • Not yet recruiting
      • Hunan Children's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Not yet recruiting
      • Dermatology Hospital of Jiangxi Province
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Not yet recruiting
      • Hangzhou Third People's Hospital
• Germany
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Not yet recruiting
      • Universitätsklinikum Münster
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Not yet recruiting
      • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7632
      • Recruiting
      • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Pest County
    • Budapest, Pest County, Hungary, 1033
      • Recruiting
      • Clinexpert Kft.
• Japan
  • Fukuoka, Japan, 811-1394
    • Recruiting
    • Fukuoka National Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 220-6208
      • Recruiting
      • Queen's square Medical Facilities Queen's square Dermatology and Allergology
  • Osaka
    • Sakai, Osaka, Japan, 593-8324
      • Recruiting
      • Dermatology and Ophthalmology Kume Clinic
  • Tokyo
    • Setagaya-ku, Tokyo, Japan, 157-0066
      • Recruiting
      • Sasamoto Children's Clinic
• Mexico
  • Chihuahua City, Mexico, 31238
    • Not yet recruiting
    • Servicios Hospitalarios de Mexico S.A. DE C.V.
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64718
      • Not yet recruiting
      • Eukarya Pharmasite S.C.
  • Veracruz Ignacio de LA Llave
    • Veracruz, Veracruz Ignacio de LA Llave, Mexico, 91900
      • Not yet recruiting
      • Arké SMO S.A de C.V
• Poland
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-573
      • Not yet recruiting
      • Luxderm Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-625
      • Not yet recruiting
      • Centrum Medyczne Evimed
  • Silesian Voivodeship
    • Chorzów, Silesian Voivodeship, Poland, 41-500
      • Recruiting
      • DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gębska
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Not yet recruiting
      • Centrum Medyczne Angelius Provita
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-436
      • Not yet recruiting
      • Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
  • Świętokrzyskie Voivodeship
    • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
      • Recruiting
      • Dermedic Jacek Zdybski
• Spain
  • Zaragoza, Spain, 50009
    • Not yet recruiting
    • Hospital Universitario Miguel Servet
  • A Coruña [LA Coruña]
    • Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
      • Not yet recruiting
      • CHUS - Hospital Clinico Universitario
  • Barcelona
    • Granollers, Barcelona, Spain, 08402
      • Not yet recruiting
      • Hospital General de Granollers
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Recruiting
      • Cahaba Dermatology & Skin Health Center
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Recruiting
      • Arkansas Research Trials
  • California
    • San Diego, California, United States, 92123
      • Not yet recruiting
      • Investigational Drug Service - Rady Childrens Hospital-San Diego
    • San Diego, California, United States, 92123
      • Not yet recruiting
      • University of California, San Diego/ Rady Children's Hospital - San Diego
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Solutions Through Advanced Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Not yet recruiting
      • Dawes Fretzin Clinical Research Group, LLC
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • Tribe Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extension; Patients who have completed other abrocitinib studies	Drug: Abrocitinib; Abrocitinib administered as liquid oral suspension.; Other Names: PF-04965842
Experimental: De novo; Patients who have not participated other abrocitinib studies	Drug: Abrocitinib; Abrocitinib administered as liquid oral suspension.; Other Names: PF-04965842

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-24 months
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.	0-24 months
Percentage of Participants with Flares	Percentage of participants reporting flares in patients with moderate-to-severe disease treated with abrocitinib.	0-24 months
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.	0-24 months
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.	0-24 months
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	Baseline, 24 months
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.	0-24 months
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.	0-24 months
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	0-24 months
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.	0-24 months
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.	0-24 months
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	0-24 months
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.	0-24 months
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.	0-24 months
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.	0-24 months
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	0-24 months
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.	0-24 months

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2025
• Primary Completion (Estimated): February 22, 2032
• Study Completion (Estimated): February 22, 2032

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: atopic dermatitis; eczema
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; abrocitinib
• Other Study ID Numbers: B7451031; 2023-509124-18-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No