Dupilumab De-escalation in Pediatric Atopic Dermatitis
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.
Conditions:
🦠 Atopic Dermatitis
🗓️ Study Start (Actual) 1 April 2024
🗓️ Primary Completion (Estimated) 1 April 2026
✅ Study Completion (Estimated) 30 April 2027
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 1 Year to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 October 2023
  • First Submitted that Met QC Criteria 30 October 2023
  • First Posted 3 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 April 2024
  • Last Update Posted 11 April 2024
  • Last Verified April 2024