Status:
RECRUITING
Dupilumab De-escalation in Pediatric Atopic Dermatitis
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Doris Duke Charitable Foundation
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
1-17 years
Phase:
PHASE4
Brief 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 sustain...
Detailed 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 ...
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
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06116526
Start Date
April 1 2024
End Date
April 30 2027
Last Update
January 15 2025
Active Locations (1)
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1
Johns Hopkins Univerisity
Baltimore, Maryland, United States, 21210