Dupilumab De-escalation in Pediatric Atopic Dermatitis

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Dupilumab De-escalation in Pediatric Atopic Dermatitis

Condition
Atopic Dermatitis
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Univerisity, Baltimore, Maryland, United States, 21210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Joy Wan, MD MSCE, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2027-04-30