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Recruiting Phase 4 NCT06116526

Dupilumab De-escalation in Pediatric Atopic Dermatitis

Phase 4 – monitoring after market approval
Conditions: Atopic Dermatitis

Sponsor: Johns Hopkins University

trial.available_in: БГ
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.
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.
Who can participate
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
Interventions
Dupilumab - Discontinuation
DRUG
Dupilumab - Dose Reduction
DRUG
Dupilumab - Standard Dose
DRUG
Locations 1
United States (1)
Johns Hopkins Univerisity
Baltimore , Maryland
Technical details
Status
Recruiting
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Maximum age
17 Years
Healthy volunteers
No
Start date
01.04.2024
Completion date
30.04.2027
Registry ID
NCT06116526
Source
clinicaltrials.gov
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