NCT06116526

Dupilumab De-escalation in Pediatric Atopic Dermatitis

Dupilumab De-escalation in Pediatric Atopic Dermatitis: A Pilot Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

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.

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 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, for a total of 3 follow-up contacts. The purpose of this study is to evaluate the feasibility and sustainability of reducing or discontinuing dupilumab in children with well-controlled AD.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Dupilumab - Discontinuation	Drug injections are discontinued.
DRUG	Dupilumab - Dose Reduction	The drug is given as a subcutaneous injection.
DRUG	Dupilumab - Standard Dose	The drug is given as a subcutaneous injection.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-04-01
• Completion: 2027-04-30
• First posted: 2023-11-03
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study