Dupilumab De-escalation in Pediatric Atopic Dermatitis
Recruiting now · Phase 4
Conditions studied: Atopic Dermatitis
In brief
This is a pilot investigator-blinded, randomized clinical trial to assess the feasibility of dupilumab treatment discontinuation or dose-reduction in children aged 1-17 years who have achieved sustained atopic dermatitis (AD) control on dupilumab.
Key facts
- Study ID
- NCT06116526
- Run by
- Johns Hopkins University
- People needed
- 30
- Starts
- 2024-04-01
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2026-04-20
Who can join
Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Johns Hopkins Univerisity — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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