RecruitingPhase 4NCT06116526
Dupilumab De-escalation in Pediatric Atopic Dermatitis
Dupilumab De-escalation in Pediatric Atopic Dermatitis: A Pilot Trial
Sponsor
Johns Hopkins University
Enrollment
30 participants
Start Date
Apr 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 1 YearMax Age: 17 Years
Inclusion Criteria7
- 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 Criteria7
- 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
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Interventions
DRUGDupilumab - Discontinuation
Drug injections are discontinued.
DRUGDupilumab - Dose Reduction
The drug is given as a subcutaneous injection.
DRUGDupilumab - Standard Dose
The drug is given as a subcutaneous injection.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06116526
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