DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Dupilumab.
- Кому может быть актуально
- Состояния в реестре: Atopic Dermatitis, Atopic Dermatitis Eczema. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Dupilumab
Administering Dupilumab 300 mg at different dosing intervals.
Первичные конечные точки
- Mean EASI [Срок оценки: 24 weeks]
Вторичные конечные точки (12)
- EASI [Срок оценки: 16 weeks]
- vIGA-AD [Срок оценки: 16 and 24 weeks]
- PtGA [Срок оценки: 16 and 24 weeks]
- NRS [Срок оценки: 16 and 24 weeks]
- POEM [Срок оценки: 16 and 24 weeks]
- DLQI [Срок оценки: 16 and 24 weeks]
- RECAP [Срок оценки: 16 and 24 weeks]
- EQ-5D-5L [Срок оценки: 16 and 24 weeks]
- Adapted iMCQ [Срок оценки: 16 and 24 weeks]
- Adapted iPCQ [Срок оценки: 16 and 24 weeks]
- Adapted iVICQ [Срок оценки: 16 and 24 weeks]
- Dupilumab serum trough levels [Срок оценки: 0 and 24 weeks]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- The subjects uses or initiates another systemic immunomodulating therapy for AE or another diagnosis.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Нидерланды · 2 центра
- Amsterdam University Medical Centers — Amsterdam
- Erasmus Medical Center — Rotterdam
Идентификаторы
NCT: NCT06004986 · 2023-504171-24-00