Dupilumab De-escalation in Pediatric Atopic Dermatitis
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 - Discontinuation, Dupilumab - Dose Reduction, Dupilumab - Standard Dose.
- Кому может быть актуально
- Состояния в реестре: Atopic Dermatitis. Базовые параметры: 1 год — 17 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
- США
- 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
Dupilumab De-escalation in Pediatric Atopic Dermatitis: A Pilot Trial
Обзор
This is a pilot investigator-blinded, randomized clinical trial to assess the feasibility of dupilumab treatment discontinuation or dose-reduction in children aged 1-17 years who have achieved sustained atopic dermatitis (AD) control on dupilumab.
Подробное описание
Participants will be randomly assigned to one of three groups: discontinuation of dupilumab; reduction of dupilumab dose; or continuation of standard dupilumab dose. During the active study treatment period, participants will be asked to complete 5 study visits. At these visits, a physician will conduct a skin examination to assess atopic dermatitis (AD) severity and participants will complete questionnaires about their AD symptoms and severity. During the observational period, participants will be asked to complete questionnaires about their AD symptoms and medication use every twelve weeks, for a total of 3 follow-up contacts. The purpose of this study is to evaluate the feasibility and sustainability of reducing or discontinuing dupilumab in children with well-controlled AD.
Вмешательства
- Препарат Dupilumab - Discontinuation
Drug injections are discontinued. - Препарат Dupilumab - Dose Reduction
The drug is given as a subcutaneous injection. - Препарат Dupilumab - Standard Dose
The drug is given as a subcutaneous injection.
Первичные конечные точки
- Percentage of Participants with Successful Dose Reduction of Dupilumab [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Percentage of Participants with Successful Discontinuation of Dupilumab [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
Вторичные конечные точки (12)
- Change in Investigator's Global Assessment (IGA) Scores [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Eczema Area and Severity Index (EASI) Scores [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient Oriented Eczema Measure (POEM) Scores [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire score [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire score [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function questionnaire score [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire score [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity questionnaire score [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Children's Dermatology Life Quality Index (CDLQI) score [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
- Change in Family Dermatology Life Quality Index (FDLQI) score [Срок оценки: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)]
Критерии участия
Критерии включения
- Aged 1 to <18 years old, either sex, any race or ethnicity
- Provide signed informed consent by parent or legal guardian and informed assent if applicable
- Has a physician confirmed diagnosis of atopic dermatitis
- Has received dupilumab for at least 12 months for the treatment of atopic dermatitis
- Has had well-controlled atopic dermatitis on dupilumab within last 6 months (defined as POEM<=7, EASI<=7, or IGA<=2)
- Able to speak English
- Able and willing to adhere to all study procedures
Критерии исключения
- Taking concurrent systemic medication for atopic dermatitis (e.g., methotrexate, cyclosporine, tralokinumab, abrocitinib, upadacitinib, systemic corticosteroids)
- Using concurrent phototherapy for atopic dermatitis
- Taking dupilumab for a clinical indication other than atopic dermatitis (such as asthma or eosinophilic esophagitis)
- Poor control of atopic dermatitis
- Poor control of asthma or eosinophilic esophagitis
- Has used an investigational drug within 90 days or plan to use an investigational drug during the study period
- Does not have health insurance or will lose health insurance during the study period
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Johns Hopkins Univerisity — Baltimore
Публикации
- Drucker AM, Wang AR, Li WQ, Sevetson E, Block JK, Qureshi AA. The Burden of Atopic Dermatitis: Summary of a Report for the National Eczema Association. J Invest Dermatol. 2017 Jan;137(1):26-30. doi: 10.1016/j.jid.2016.07.012. Epub 2016 Sep 8. PMID 27616422
- Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020 Aug 1;396(10247):345-360. doi: 10.1016/S0140-6736(20)31286-1. PMID 32738956
Идентификаторы
NCT: NCT06116526 · IRB00405441