DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dupilumab.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis, Atopic Dermatitis Eczema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
While dupilumab is an effective treatment for atopic eczema, it is expensive and not without the risk of unwanted adverse events. Aiming for the lowest possible dose is important. The currently approved dose is a single loading dose of 600 mg, followed by 300 mg every 2 weeks. However, there is evidence that the intervals between doses could be extended in disease-controlled patients while maintaining the same effectiveness. The objective of this study is to assess the (cost)effectiveness and safety of dupilumab dose reduction in patients with controlled atopic eczema. A multicenter, single-blinded, non-inferiority randomized controlled trial will be performed, that is embedded in the TREatment of ATopic eczema (TREAT) NL registry. Adult patients who are already undergoing dupilumab treatment and meet the Treat-to-Target criteria will be assigned randomly to one of three groups: receiving dupilumab 300 mg every 2 weeks, every 3 weeks, or every 4 weeks. The study will cover a duration of 24 weeks, during which participants will have three hospital visits (at week 0, week 16 and week 24) and one telephone appointment (at week 8). These sessions will involve assessments of both physician and patient-reported disease severity, quality of life and the evaluation of dupilumab serum trough levels. Please refer below for a comprehensive overview of the outcome measures.
Interventions
- Drug Dupilumab
Administering Dupilumab 300 mg at different dosing intervals.
Primary outcome measures
- Mean EASI [Time frame: 24 weeks]
Secondary outcome measures (12)
- EASI [Time frame: 16 weeks]
- vIGA-AD [Time frame: 16 and 24 weeks]
- PtGA [Time frame: 16 and 24 weeks]
- NRS [Time frame: 16 and 24 weeks]
- POEM [Time frame: 16 and 24 weeks]
- DLQI [Time frame: 16 and 24 weeks]
- RECAP [Time frame: 16 and 24 weeks]
- EQ-5D-5L [Time frame: 16 and 24 weeks]
- Adapted iMCQ [Time frame: 16 and 24 weeks]
- Adapted iPCQ [Time frame: 16 and 24 weeks]
- Adapted iVICQ [Time frame: 16 and 24 weeks]
- Dupilumab serum trough levels [Time frame: 0 and 24 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 2 centers
- Amsterdam University Medical Centers — Amsterdam
- Erasmus Medical Center — Rotterdam
Identifiers
NCT: NCT06004986 · 2023-504171-24-00