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

2023-504171-24-00

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.

2023-08-14

2024-10-15

2024-12-31

Recruiting

Early phase I

216

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 216, 'type': 'ESTIMATED'}}

2023-08-31