Dupilumab De-escalation in Pediatric Atopic Dermatitis: A Pilot Trial
Johns Hopkins University
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.
Description
Participants will be randomly assigned to one of three groups: discontinuation of dupilumab; reduction of dupilumab dose; or continuation of standard dupilumab dose. During the active study treatment period, participants will be asked to complete 5 study visits. At these visits, a physician will conduct a skin examination to assess atopic dermatitis (AD) severity and participants will complete questionnaires about their AD symptoms and severity. During the observational period, participants will be asked to complete questionnaires about their AD symptoms and medication use every twelve weeks,…
Eligibility
- Age range
- 1–17 years
- Sex
- All
- Healthy volunteers
- No
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 der…
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.
Location
- Johns Hopkins UniverisityBaltimore, Maryland