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Active Not Recruiting NCT06004986

DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

Conditions: Atopic Dermatitis, Atopic Dermatitis Eczema

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 216
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Location: Amsterdam University Medical Centers Amsterdam North Holland

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06004986). StuddyBuddy aggregates publicly available trial information.