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A Study of Abrocitinib for Moderate-to-Severe Eczema in Children

This study is testing a medicine called abrocitinib in children aged 6 to less than 12 years old who have moderate-to-severe eczema (atopic dermatitis). The goal is to see if abrocitinib can improve eczema and if it is safe. Participants will be randomly assigned, like flipping a coin, to receive either abrocitinib or a placebo (an inactive substance that looks like the medicine) for 16 weeks. The study will last about 24 weeks in total. Researchers will measure how much eczema improves and monitor your child's health through clinic visits, questionnaires, and by tracking scratching with a special wrist device. Success in the study means a significant improvement in eczema symptoms.

Study design
This is an interventional study with 150 planned participants. Participants will be randomly assigned to receive either abrocitinib or a placebo.
What's involved
Your child would take the study medicine daily for 16 weeks and attend clinic visits. They would also use an electronic diary and wear a wrist device to track scratching. Lab tests, physical exams, and vital signs will be checked throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The main study outcomes are measured at Week 12, and the total study duration is about 24 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06807268

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

Recruiting
PHASE3Ages 6–11InterventionalTreatment
Pfizer
~150 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:AbrocitinibPlacebo

At a glance

Recruiting sites
42 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over At week 12
+1 more outcome measured

Conditions

Eczema

Explore related trials

Atopic Dermatitis

Where it's being run

43 sites across 38 states
California2
South Carolina2
China2
Japan2
Silesian Voivodeship2
Alabama1
Arkansas1
Florida1

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

Exclusion

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:
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.

What this trial measures

  • 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 12At 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

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