Abrocitinib Treatment of Atopic Dermatitis in Children 2 to Less Than 6 Years of Age

A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 2 TO LESS THAN 6 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

This clinical study is designed to test how well a medicine called abrocitinib works and how safe it is for young children (ages 2 to under 6) who have moderate-to-severe eczema (also known as atopic dermatitis).Eczema is a skin condition that can cause the skin to be dry, itchy, have scaly patches, blisters and skin infections.

How the study works:

• Children will be randomly placed into two groups:

  • 2 out of 3 will get the real medicine (abrocitinib).
  • 1 out of 3 will get a placebo (a look-alike liquid with no active medicine).
• Neither the families nor the doctors will know which group each child is in (this is called double-blind).

This study is seeking for children:

• between 2 and under 6 years old.
• Who have had eczema for at least 1 year.
• Who have moderate-to-severe eczema at the start of the study, based on skin area affected and symptom scores.

The medicine is given once a day as a liquid. The amount given depends on the child's body weight. If the child's eczema doesn't improve enough between weeks 4 and 8, the dose might be increased (still without anyone knowing which group they're in), unless the child can't tolerate it.

All children will also use standard medicated creams during the study. The study will be up to 24 weeks long and there will be a screening period (up to 28 days) to make sure each child qualifies for the study.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Abrocitinib

Detailed Description

This is a 16-week, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of abrocitinib compared to placebo in participants aged 2 to <6 years with moderate-to-severe AD. Participants will be screened within 28 days prior to the first dose of study intervention to confirm study eligibility. Participants who continue to meet eligibility criteria at baseline will be randomized 2:1 to abrocitinib oral suspension (at 100 mg adult equivalent dose level [AED] once daily [QD]) or matching placebo. Participants will be stratified by their baseline vIGA (score of 3 or 4). At the starting dose level of 100 mg QD AED, the dose volume (in mL of oral suspension) will depend on the participant's body weight.

• Study Type: Interventional
• Enrollment (Estimated): 90
• 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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Children aged 2 to <6 years at the time of informed consent /assent.

Disease Characteristics:

• All participants must meet all of the following 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;
• 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 WSI-NRS ≥4).

For countries outside the US:

Eligible participants must have:

• a documented history within 6 months before the screening visit of inadequate response to treatment with topical medicated therapy for AD (eg, TCS and TCI) for at least 4 weeks, or;
• required at least 1 systemic therapy for control of their disease.

For US only:

Eligible participants are those whose disease is not adequately controlled with at least 1 systemic therapy or when the use of systemic therapies is inadvisable.

• Prior systemic therapies may include biologics such as dupilumab, oral agents such as corticosteroids, cyclosporine, methotrexate Note that an inadequate response to topical treatments alone is not sufficient for eligibility in the US.

Other Inclusion Criteria:

• Body weight ≥10 kg.

Exclusion Criteria:

• 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.
• Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline), or have non-typical pediatric superficial skin infections (excluding common self-limiting viral conditions such as verruca vulgaris and molluscum contagiosum) 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.
• 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, sensitive P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates with narrow therapeutic index are not allowed in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abrocitinib; Participants will receive liquid oral suspension of Abrocitinib.	Drug: Abrocitinib; Administered orally; Other Names: PF-04965842
Placebo Comparator: Matching Placebo; Participants will receive liquid oral suspension of matching placebo.	Drug: Placebo; Administered orally

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 percentage of responders based on vIGA at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo.	Baseline, week 12
Response based on achieving ≥75% improvement from baseline in Eczema and Severity Index (EASI) at Week 12	The difference in percentage of responders based on EASI-75 at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline (CFB) in the Worst Scratch/Itch Numerical Rating Scale (WSI-NRS) at Week 2	The difference in mean CFB in WSI-NRS total score at Week 2 in participants with moderate-to-severe AD treated with abrocitinib versus placebo	Baseline, Week 2
Response based on achieving at least a 4-point improvement from baseline in the WSI-NRS at Week 12	The difference in percentage of responders based on achieving at least a 4-point improvement from baseline in the WSI-NRS at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo	Week 12
Response based on achieving WSI-NRS <2 at Week 12	The difference in percentage of responders based on achieving WSI-NRS <2 at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo.	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 (Estimated): May 1, 2027
• Primary Completion (Estimated): April 10, 2029
• Study Completion (Estimated): April 10, 2029

Study Registration Dates

• First Submitted: September 11, 2026
• First Submitted That Met QC Criteria: September 11, 2026
• First Posted (Actual): September 16, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: 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; abrocitinib
• Other Study ID Numbers: B7451030; 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk); 2025-523215-11-00 (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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

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