RecruitingPhase 4NCT06004986

DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

DUPI REDUCE Trial (DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema): a Multicenter, Low-intervention, Non-inferiority Randomized Controlled Trial, Embedded in the TREAT NL Registry


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

216 participants

Start Date

Aug 14, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria1

  • The subjects uses or initiates another systemic immunomodulating therapy for AE or another diagnosis.

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Interventions

DRUGDupilumab

Administering Dupilumab 300 mg at different dosing intervals.


Locations(2)

Amsterdam University Medical Centers

Amsterdam, North Holland, Netherlands

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

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NCT06004986


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