NL-OMON55352已完成3 期
A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) - Phase 3, 3 part study in EoE patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •A documented diagnosis of EoE by endoscopic biopsy prior to screening, as
- •demonstrated by intraepithelial eosinophilic infiltration (peak cell count >=15
- •eosinophils/high power field [eos/hpf]) from at least one esophageal region and
- •performed after at least 8 weeks of treatment with a high dose proton pump
- •inhibitor (PPI) regimen. If the patient discontinued PPI therapy, the biopsy
- •must have been performed within 2 weeks of the date of discontinuation. If a
- •prior (historical) endoscopic biopsy meeting these criteria is not available
- •(or no prior biopsy is available), patients who meet other clinical and
- •laboratory eligibility criteria will undergo treatment with a high dose PPI
- •regimen for at least 8 weeks during the screening period before their baseline
- •endoscopy/biopsies.
- •Baseline endoscopic biopsies with a demonstration on central reading of
- •intraepithelial eosinophilic infiltration (peak cell count >=15 eos/hpf) in at
- •least 2 of the 3 biopsied esophageal regions (proximal, mid, or distal)
- •History (by patient report) of an average of at least 2 episodes of dysphagia
- •(with intake of solids) per week in the 4 weeks prior to screening
- •At least 4 episodes of dysphagia in the 2 weeks prior to baseline, documented
- •via eDiary, at least 2 of which require liquids, coughing or
- •gagging, vomiting, or medical attention to obtain relief
- •Completed at least 11 of 14 days of the Dysphagia Symptom Questionnaire (DSQ)
- •eDiary data entry in the 2 weeks prior to the baseline visit (visit 3)
- •Baseline DSQ score >=10
排除标准
- •Body weight <=40 kg
- •Prior participation in a dupilumab clinical trial, or past or current
- •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
- •Other causes of esophageal eosinophilia or the following conditions:
- •hypereosinophilic syndrome and eosinophilic granulomatosis with
- •polyangiitis (Churg-Strauss syndrome)
- •Note: Patients with eosinophilic gastroenteritis are eligible, provided they
- •meet other eligibility criteria.
- •Active Helicobacter pylori infection
- •History of achalasia, Crohn*s disease, ulcerative colitis, celiac disease,
- •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
研究者
相似试验
进行中（未招募）
1 期
A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)EUCTR2018-000844-25-DERegeneron Pharmaceuticals, Inc.290
进行中（未招募）
1 期
A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)Eosinophilic Esophagitis (EoE)MedDRA version: 20.1Level: PTClassification code 10064212Term: Eosinophilic oesophagitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2018-000844-25-ESRegeneron Pharmaceuticals, Inc.425
进行中（未招募）
1 期
A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)EUCTR2018-000844-25-GBRegeneron Pharmaceuticals, Inc.290
进行中（未招募）
1 期
A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)EUCTR2018-000844-25-FRRegeneron Pharmaceuticals, Inc.425
进行中（未招募）
1 期
A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE)EUCTR2018-000844-25-SERegeneron Pharmaceuticals, Inc.290