Dupilumab De-escalation in Pediatric Atopic Dermatitis
Recruiting · NCT06116526 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
Dupilumab - DiscontinuationDupilumab - Dose ReductionDupilumab - Standard Dose
What this trial is about
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.
Who can take part
Age range
1 Year to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed across 1 US state.
- Johns Hopkins Univerisity - Baltimore, Maryland, United States