Dupilumab De-escalation in Pediatric Atopic Dermatitis

• Status: Recruiting
• Trial end date: 2027-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Doris Duke Charitable Foundation
• Treatments: Antibodies, Monoclonal

Criteria

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