2023-504171-24-00招募中4 期
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.
Amsterdam UMC3 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2023年6月14日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 3
- 主要终点
- The mean Eczema Area and Severity Index (EASI) at week 16.
研究概览
简要总结
To evaluate and compare the efficacy of dupilumab 300 mg every 2 weeks, every 3 weeks and every 4 weeks, 16 weeks after randomization.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The subject is an adult.
- •The subject has a diagnosis of atopic eczema.
- •The subject receives dupilumab 300 mg every 2 weeks for the treatment of atopic eczema.
- •The subject has controlled disease according to the Treat-to-Target criteria.
- •The subject has voluntarily signed and dated an informed consent prior to any study related procedure or has a legal representative to do so and is willing to comply with the requirements of this study protocol.
排除标准
- •The subject uses or initiates other systemic immunomodulating therapy for atopic eczema or another diagnosis.
结局指标
主要结局
The mean Eczema Area and Severity Index (EASI) at week 16.
The mean Eczema Area and Severity Index (EASI) at week 16.
次要结局
- EASI at week 24.
- Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD).
- Patient self-reported Global Assessment of disease severity (PtGA).
- Peak Pruritus Numerical Rating Scale (NRS).
- Patient-Oriented Eczema Measure (POEM).
- Dermatology Life Quality Index (DLQI).
- Recap of atopic eczema (RECAP).
- Dupilumab costs.
- EuroQol-5 dimensions-5 level/Youth (EQ-5D-5L): adults and caregivers.
- Adapted iMCQ (iMTA Medical Consumption Questionnaire).
- Adapted iPCQ (iMTA Productivity Cost Questionnaire).
- Adapted iVICQ (iMTA Valuation of Informal Care Questionnaire).
- Number of adverse events of special interests (AEoSIs), severe adverse events, serious adverse events and suspected unexpected serious adverse reactions (SUSARs), categorized according to medical dictionary for regulatory activities (MedDRA).
- Percentage of dropouts and reasons.
- Dupilumab serum trough levels of 40 patients.
研究者
Prof. Dr. Ph.I. Spuls
Scientific
Amsterdam UMC
研究点 (3)
Loading locations...
相似试验
招募中
4 期
A phase IV, randomized double blinded placebo-controlled study on the barrier restoring capacity of Dupilumab in type 2 airway disease: CRSwNP2023-504014-30-00UZ Leuven44
招募中
3 期
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC 8)2023-506891-28-00Astrazeneca AB280
招募中
1 期
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.Atopic eczemaMedDRA version: 21.1Level: LLTClassification code: 10003641Term: Atopic eczema Class: 10040785CTIS2023-504171-24-00Amsterdam UMC216
招募中
不适用
Early and Long-Term Efficacy and Immune Changes With Dupilumab in Prurigo NodularisNCT07276425UMC Utrecht40
招募中
2 期
Olaparib and durvalumab (MEDI4736) in patients with metastatic pancreatic cancer and DNA Damage Repair genes alterations2024-510970-26-00Asociacion Grupo Tratamiento De Tumores Digestivos40