DUPI REDUCE Trial: Dupilumab Dose Reduction in Patients With Controlled Atopic Eczema, a Multicenter Randomized Controlled Trial Embedded in the TREAT NL Registry

What this Trial Is About

Researchers are evaluating the cost-effectiveness and safety of reducing the frequency of dupilumab doses in adults with well-controlled atopic eczema. This randomized controlled trial aims to compare the outcomes of patients continuing the standard dosing schedule versus those receiving extended intervals between doses, focusing on disease severity, quality of life, and drug levels in the blood. The study is embedded within a larger registry and involves adult patients already treated with dupilumab who meet specific control criteria. Participants will be randomly assigned to one of three groups receiving dupilumab 300 mg subcutaneously every 2 weeks, every 3 weeks, or every 4 weeks for 24 weeks. The study includes three hospital visits at weeks 0, 16, and 24, plus a telephone check at week 8. These visits will include assessments by both doctors and patients and testing of drug levels in the blood to monitor treatment effects and safety. During the study, participants will undergo various evaluations including physician and patient assessments of eczema severity and quality of life questionnaires. Researchers will measure the primary outcome using the Eczema Area and Severity Index (EASI) at 24 weeks, along with several secondary outcomes at weeks 16 and 24, such as patient global assessments and adverse event monitoring. This comprehensive monitoring aims to understand the impact of dose reduction on disease control and patient well-being.

DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema