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Can a daily liquid medicine calm severe eczema in toddlers and preschoolers?

NCT ID NCT07823595

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether abrocitinib, an oral medicine taken once daily as a liquid, safely improves moderate-to-severe eczema in children aged 2 to under 6. About 90 children with a documented eczema diagnosis for at least a year will join. Two out of three will receive abrocitinib and one out of three will receive a placebo, and neither families nor doctors will know which group each child is in. All children will also use standard medicated creams. The study lasts up to 24 weeks, including a screening period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abrocitinib, an oral medicine given as a daily liquid
What this could lead to
If it works, abrocitinib could give very young children with moderate-to-severe eczema an oral treatment option alongside medicated creams.
What could go wrong
This is a small, 16-week study in 90 children, so it may not show a clear benefit or may reveal side effects that limit use. Results in young children may not match those in older patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2027

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 5 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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