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

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.

Study Overview

• Status: Recruiting
• Conditions: Eczema
• Intervention / Treatment: Drug: Abrocitinib; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• 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 Contact Backup: Name: Nancy A Sherman, BA; Phone Number: 2127332323; Email: Nancy.Sherman@Pfizer.com

Study Locations

• China
  • Shanghai, China, 200092
    • Recruiting
    • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200062
    • Recruiting
    • Shanghai Children's Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100045
      • Recruiting
      • Beijing Children's Hospital, Capital Medical University
  • Guangdong
    • Shenzhen, Guangdong, China, 518026
      • Recruiting
      • Shenzhen Children's Hospital
  • Hunan
    • Changsha, Hunan, China, 410007
      • Recruiting
      • Hunan Children's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Recruiting
      • Dermatology Hospital of Jiangxi Province
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Recruiting
      • Shanghai Children's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Hangzhou Third People's Hospital
• Germany
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Not yet recruiting
      • Universitatsklinikum Munster
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Recruiting
      • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
• Hungary
  • Pécs, Hungary, 7622
    • Recruiting
    • University of Pecs
  • Baranya
    • Pécs, Baranya, Hungary, 7632
      • Recruiting
      • Pécsi Tudományegyetem Klinikai Központ
  • Bekes County
    • Békéscsaba, Bekes County, Hungary, 5600
      • Not yet recruiting
      • Trial Pharma Kft.
  • Pest County
    • Budapest, Pest County, Hungary, 1033
      • Recruiting
      • Clinexpert Kft.
• Japan
  • Fukuoka, Japan, 811-1394
    • Recruiting
    • Fukuoka National Hospital
  • Fukuoka, Japan, 819-0042
    • Recruiting
    • Saruta Dermatology Clinic
  • 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 México S.A. de C.V. (Hospital Angeles Chihuahua)
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64718
      • Not yet recruiting
      • Eukarya Pharmasite S.C.
  • Veracruz
    • Veracruz, Veracruz, Mexico, 91900
      • Not yet recruiting
      • Arke SMO S.A. de C.V.
• Poland
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-573
      • Recruiting
      • Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. N. med. Dorota Krasowska
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-625
      • 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
      • Recruiting
      • Centrum Medyczne Angelius Provita
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-436
      • 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
    • Recruiting
    • Hospital Universitario Miguel Servet
  • A Coruña [LA Coruña]
    • Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
      • Recruiting
      • CHUS - Hospital Clinico Universitario
  • Barcelona [barcelona]
    • Granollers, Barcelona [barcelona], Spain, 08402
      • Recruiting
      • Hospital General de Granollers
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Recruiting
      • Cahaba Dermatology & Skin Health Center, LLC
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Recruiting
      • Arkansas Research Trials
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Investigational Drug Service - Rady Childrens Hospital-San Diego
    • San Diego, California, United States, 92123
      • Recruiting
      • University of California, San Diego/Rady Children's Hospital-San Diego; Pediatric & Adolescent Derm
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Solutions Through Advanced Research
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Recruiting
      • Dawes Fretzin Clinical Research Group, LLC
  • Missouri
    • St Louis, Missouri, United States, 63104
      • Recruiting
      • Saint Louis University - Department of Dermatology
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • Tribe Clinical Research, LLC
  • Texas
    • San Antonio, Texas, United States, 78235
      • Recruiting
      • Texas Dermatology and Laser Specialists

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abrocitinib; Abrocitinib administered as liquid oral suspension.	Drug: Abrocitinib; Abrocitinib administered as liquid oral suspension.; Other Names: PF-04965842
Placebo Comparator: Matching Placebo; Placebo administered as liquid oral suspension.	Other: Placebo; Placebo administered as liquid oral suspension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At week 12
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	At week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At week 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	At week 12
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	At week 12

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): July 24, 2025
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): May 2, 2027

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): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Skin and Connective Tissue Diseases; Dermatitis; Eczema; Substandard Drugs; Pharmaceutical Preparations; abrocitinib
• Other Study ID Numbers: B7451023; 2023-509121-51-00 (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
• product manufactured in and exported from the U.S.: Yes