NCT07112378招募中3 期
A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 14
- 主要终点
- Incidence of treatment-emergent Serious Adverse Events (SAEs)
研究概览
简要总结
This study is researching an experimental drug called dupilumab (called "study drug"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment.
The aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
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
- Single (Care Provider)
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged ≥6 months and weighing ≥5 kg and <15 kg at screening with active EoE
- •History of symptom(s) determined by the investigator to be the result of EoE in the month prior to screening, as defined in the protocol
- •Baseline endoscopic biopsies, performed during the screening period, with a demonstration on central reading of intraepithelial eosinophilic infiltration in at least 2 of the 3 biopsied esophageal regions, as defined in the protocol
排除标准
- •Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab
- •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
- •Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
- •Active Helicobacter pylori infection
- •History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery
- •Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening
- •History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopic procedure
- •Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy
- •NOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply
研究组 & 干预措施
Dosing Regimen 2
Experimental
干预措施: dupilumab (Drug)
Dosing Regimen 1
Experimental
干预措施: dupilumab (Drug)
结局指标
主要结局
Incidence of treatment-emergent Serious Adverse Events (SAEs)
时间窗: Up to 24 Weeks
次要结局
- Titer of ADA to dupilumab(Up to Week 36)
- Proportion of patients achieving peak esophageal intraepithelial eosinophil count of <15 eos/hpf (400×)(At Week 24)
- Incidence of Anti-Drug Antibody (ADA) to dupilumab(Up to Week 36)
- Incidence of Neutralizing Antibody (NAb) to dupilumab(Up to Week 36)
- Incidence of treatment-emergent Adverse Event of Special Interest (AESIs)(Up to 24 Weeks)
- Incidence of TEAEs(Up to 24 Weeks)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) leading to permanent discontinuation of study treatment(Up to 24 Weeks)
- Proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high power field (eos/hpf) (400×)(At Week 24)
- Percent change in peak esophageal intraepithelial eosinophil count (eos/hpf)(Baseline to Week 24)
- Change in body weight for age percentile(Baseline up to Week 24)
- Concentrations of functional dupilumab in serum(Baseline up to Week 24)
研究者
研究点 (14)
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