Dupilumab De-escalation in Pediatric Atopic Dermatitis

This study is for children aged 1 to 17 who have atopic dermatitis (eczema) that has been well-controlled with dupilumab for at least 12 months. Researchers want to see if it's possible to reduce the dose of dupilumab or stop it completely in these children. You would be randomly assigned to one of three groups: stopping dupilumab, taking a reduced dose, or continuing the standard dose. The main goals are to see how many participants successfully reduce their dose or stop dupilumab. The study is currently recruiting 30 participants, but its status is unclear.

Study design: This is a pilot, investigator-blinded, randomized clinical trial with 30 planned participants.
What's involved: Participants will have 5 study visits during the active treatment phase, including skin exams and questionnaires. During the observational phase, you will complete questionnaires about symptoms and medication every 12 weeks for a total of 3 follow-up contacts.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 52 weeks, with an active protocol phase through week 16 and an observational phase through week 52.

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Dupilumab De-escalation in Pediatric Atopic Dermatitis

Recruiting

PHASE4Ages 1–17InterventionalTreatment

Johns Hopkins University

~30 participants

Updated 2026-04-20 on ClinicalTrials.gov

What's tested:Dupilumab - DiscontinuationDupilumab - Dose ReductionDupilumab - Standard Dose

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Percentage of Participants with Successful Dose Reduction of Dupilumab

Measured over From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)

+1 more outcome measured

Conditions

Atopic Dermatitis

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

Joy Wan, MD MSCE · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Zeena Mestari, BA

[email protected]

‭+1 (848) 702-4101‬

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged 1 to \<18 years old, either sex, any race or ethnicity

Provide signed informed consent by parent or legal guardian and informed assent if applicable

Has a physician confirmed diagnosis of atopic dermatitis

Has received dupilumab for at least 12 months for the treatment of atopic dermatitis

Has had well-controlled atopic dermatitis on dupilumab within last 6 months (defined as POEM\<=7, EASI\<=7, or IGA\<=2)

Able to speak English

Able and willing to adhere to all study procedures

Exclusion

Taking concurrent systemic medication for atopic dermatitis (e.g., methotrexate, cyclosporine, tralokinumab, abrocitinib, upadacitinib, systemic corticosteroids)

Using concurrent phototherapy for atopic dermatitis

Taking dupilumab for a clinical indication other than atopic dermatitis (such as asthma or eosinophilic esophagitis)

Poor control of atopic dermatitis

Poor control of asthma or eosinophilic esophagitis

Has used an investigational drug within 90 days or plan to use an investigational drug during the study period

Does not have health insurance or will lose health insurance during the study period

What this trial measures

Percentage of Participants with Successful Dose Reduction of DupilumabFrom Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
Successful de-escalation is defined as maintaining a reduced dose (i.e., less frequent administration) of dupilumab after initial de-escalation on week 0. Patients who require re-escalating the dose of dupilumab to standard dosing or adding other systemic treatments for their AD will be regarded as treatment failure.
Percentage of Participants with Successful Discontinuation of DupilumabFrom Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
Successful discontinuation is defined as maintaining discontinuation of dupilumab after initial discontinuation on week 0. Patients who require resumption of dupilumab or beginning other systemic treatments for their AD will be regarded as treatment failure.

Trialytics