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Recruiting Phase 4 NCT06004986

DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

Trial Parameters

Condition Atopic Dermatitis
Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 216
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-08-14
Completion 2025-10-01
Interventions
Dupilumab

Brief Summary

The goal of this randomized controlled trial is to study the (cost)effectiveness of extending the intervals between dupilumab doses in patients with well-controlled atopic eczema, while considering physician- and patient-reported disease severity, quality of life, and dupilumab serum trough levels. Patients will be divided randomly into three groups, receiving dupilumab 300 mg every 2 weeks, every 3 weeks, or every 4 weeks. Researchers will then compare the outcomes among these three groups.

Eligibility Criteria

Inclusion Criteria: * The subject is an adult, * Has a diagnosis of AE, * Receives dupilumab 300 mg q2w for the treatment of AE, * Has controlled disease according to the Treat-to-Target criteria, * Agrees to the possibility that the dosage of dupilumab will be lowered, * Has voluntarily signed and dated an informed consent prior to any study related procedure. Exclusion Criteria: * The subjects uses or initiates another systemic immunomodulating therapy for AE or another diagnosis.

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