NCT06101095进行中（未招募）4 期
A Phase 4, Randomized, Multicenter, Double-blind, Parallel-group, 24 Weeks, Placebo-controlled Study Followed by 104 Weeks Open-label to Assess Dupilumab Efficacy on Esophageal Function and Remodeling in Adult Participants With Eosinophilic Esophagitis (EoE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 69
- 试验地点
- 30
- 主要终点
- Change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe (EndoFLIP)
研究概览
简要总结
This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis.
Duration of study period (per participant)
- Screening period: Up to 12 weeks before Week 0
- Randomized double-blind period: 24 weeks
- Open label period: 104 weeks
- Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first.
There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).
详细描述
The duration per participant will be up to 152 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A documented diagnosis of EoE by endoscopic biopsy.
- •Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration.
- •History (by participant report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening.
- •Body weight ≥40 kg.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome).
- •Active Helicobacter pylori infection.
- •History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery.
- •Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening.
- •History of bleeding disorders or esophageal varices.
- •Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline.
- •Initiation or change of a food elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to screening.
- •Participation in prior dupilumab clinical study or participants currently treated or have been treated with commercially available dupilumab or contraindicated to dupilumab per local labelling.
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
研究组 & 干预措施
Dupilumab
Experimental
Subcutaneous injection (SC) as per protocol
干预措施: Dupilumab (Drug)
Placebo
Placebo Comparator
SC injection as per protocol
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe (EndoFLIP)
时间窗: From baseline to Week 24
Distensibility plateau provides an assessment of esophageal function. An increase in distensibility plateau indicates an improvement in esophageal function and a decrease in distensibility plateau indicates a worsening of esophageal function.
次要结局
- Change from baseline in EoE-HSS Stage(From Baseline up to Week 128)
- Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of ≤6 eosinophils/high power field (Eos/HPF)(At Weeks 24, 76 and 128)
- Proportion of participants who achieved peak Esophageal Intraepithelial Eosinophil Count of ≤15 Eos/HPF(At Weeks 24, 76 and 128)
- Change from baseline in normalized enrichment score (NES) for EoE diagnostic panel (EDP) transcriptome signature(From baseline up to Week 128 (EOT))
- Incidence of adverse events of special interest (AESIs)(From the first IMP administration up to end of post treatment follow up period (week139))
- Change from baseline in normalized enrichment score (NES) for type 2 inflammation transcriptome signature(From Baseline up to Week 128 (EOT))
- Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs)(From the first IMP administration up to end of post treatment follow up period (week139))
- Percent change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe(From Baseline up to Week 128)
- Absolute change from baseline in esophageal distensibility plateau as measured by Functional Lumen Imaging Probe(From baseline up to Week128)
- Change from baseline in eosinophilic esophagitis-endoscopic reference score (EoE-EREFS)(From baseline up to Week 128)
- Change from baseline in eosinophilic esophagitis (EoE-HSS) Grade(From Baseline up to Week 128)
研究者
研究点 (30)
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