Dupilumab De-escalation in Pediatric Atopic Dermatitis

Last updated: January 13, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

4

Condition

Eczema (Atopic Dermatitis - Pediatric)

Allergy

Allergies & Asthma

Treatment

Dupilumab - Discontinuation

Dupilumab - Standard Dose

Dupilumab - Dose Reduction

Clinical Study ID

NCT06116526
IRB00405441
  • Ages 1-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ifapplicable

  • 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 (definedas POEM<=7, EASI<=7, or IGA<=2)

  • Able to speak English

  • Able and willing to adhere to all study procedures

Exclusion

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 asasthma 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 investigationaldrug during the study period

  • Does not have health insurance or will lose health insurance during the study period

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Dupilumab - Discontinuation
Phase: 4
Study Start date:
April 01, 2024
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • Johns Hopkins Univerisity

    Baltimore, Maryland 21210
    United States

    Active - Recruiting

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