2026-526348-11-01招募中4 期
Optimization of Dupilumab Maintenance Dosing in Eosinophilic Esophagitis: A Phase IV, Randomized, Controlled, Single-Blind, Non-Inferiority Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Proportion of patients with eosinophilic esophagitis maintaining complete remission at Week 52.
研究概览
简要总结
To determine whether dose de-escalation of dupilumab 300mg SC Q2W is non-inferior to 300mg SC QW dosing in maintaining complete remission, a composite endpoint of clinical, endoscopic, and histologic remission in adults with eosinophilic esophagitis.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years of age.
- •Documented diagnosis of EoE by endoscopic biopsy, confirmed by intraepithelial eosinophilic infiltration (peak cell count ≥15 eosinophils [eos]/high-power field [hpf]).
- •On dupilumab therapy for a minimum of 24 weeks prior to screening.
- •Documented complete remission consisting of clinical (DSQ <10), endoscopic (EREFS score ≤2), and histologic remission (PEC <15 eos/hpf), confirmed at screening.
排除标准
- •Any contraindication or safety condition that would preclude the standard, approved use of dupilumab.
- •Treatment with swallowed topical or systemic corticosteroids within 8 weeks prior to baseline.
- •Initiation of PPI therapy or any change in PPI dose within the 8 weeks prior to screening. Patients receiving PPIs must remain on same dose throughout the study.
- •Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Patients on a food-elimination diet must remain on the same diet throughout the study.
- •Oesophageal dilatation within the 12 weeks prior to screening.
- •Presence of an esophageal stricture that cannot be traversed with a standard, diagnostic, 9 to 10 mm upper endoscope or any critical oesophageal stricture that requires dilation at screening.
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
结局指标
主要结局
Proportion of patients with eosinophilic esophagitis maintaining complete remission at Week 52.
Proportion of patients with eosinophilic esophagitis maintaining complete remission at Week 52.
次要结局
- Proportions of patients maintaining clinical, endoscopic, and histologic remission individually at Week 52.
- Time to loss of complete remission (clinical, endoscopic, and histologic) and of individual clinical, endoscopic, and histologic remission.
- Number of adverse events (AEs), severe adverse events (SAEs), serious adverse events and suspected unexpected serious adverse events (SUSARs), categorized according to the medical dictionary for regulatory activities (MedDRA).
- Health-related quality of life as measured by the validated EoE-QoL-A questionnaire.
- Health utility values and QALYs measured by EQ-5D-5L.
- Healthcare resource utilization & productivity impacts measured using adapted iMCQ and iPCQ.
- Exploratory analyses of biomarkers collected from esophageal biopsies and peripheral blood to identify early predictors of loss of remission during dupilumab dose de-escalation.
研究者
D.R. Nijman
Scientific
Amsterdam UMC Stichting
研究点 (1)
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