Can a daily liquid medicine calm severe eczema in toddlers and preschoolers?
NCT ID NCT07823595
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2027
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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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
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2 to 5 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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