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Long-term Study of Abrocitinib for Moderate to Severe Eczema in Children

This study is looking at the long-term safety and effectiveness of a liquid medicine called abrocitinib for children aged 2 to 11 years old who have moderate to severe atopic dermatitis (eczema). Some children in the study will have already participated in other abrocitinib studies, while others will be new to abrocitinib. All participants will receive abrocitinib oral suspension, which may be given with or without other skin medications. The main goal is to track any side effects over 24 months. The study aims to enroll about 500 children globally. The current status of the study is unclear.

Study design
This is an open-label Phase 3 study, meaning everyone knows what treatment is being given. It plans to enroll about 500 participants.
What's involved
Participants will receive abrocitinib oral suspension for up to 2 years. The study will track safety events over 24 months.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events for 0-24 months.

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

NCT06807281

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

Recruiting
PHASE3Ages 2–11InterventionalTreatment
Pfizer
~500 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Abrocitinib

At a glance

Recruiting sites
27 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation
Measured over 0-24 months

Conditions

Atopic Dermatitis

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Atopic Dermatitis

Where it's being run

38 sites across 33 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?

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Eligibility criteria

Inclusion

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.

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.
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

What this trial measures

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation0-24 months

    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.