RECRUITING

Dupilumab De-escalation in Pediatric Atopic Dermatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-01

Study Completion:2027-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06116526

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.

Ages Eligible for Study:1 Year to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Hsing-Jou Su, MD

CONTACT

9292178030

hsu28@jh.edu

Karin Kartawira, BA

CONTACT

667-290-4998

kkartaw1@jh.edu

Principal Investigator

Joy Wan, MD MSCE

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Univerisity

Baltimore, Maryland, 21210

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Joy Wan, MD MSCE, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

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

Study Start Date2024-04-01

Study Completion Date2027-04-30

Study Record Updates

Study Start Date2024-04-01

Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

Atopic Dermatitis