EUCTR2022-001294-31-DK进行中（未招募）1 期
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING) - CROSSING
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.
- •2. Weight = 40 kg at Visit 1
- •3. Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.
- •4. Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia (any severity of food going
- •down slowly or being stuck in the throat) per week in the 4 weeks prior to Visit 1.
- •5. Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and during the course of the study (stable diet is defined as no initiation
- •of single or multiple elimination diets or reintroduction of previously eliminated food groups).
- •6. May be on any background medication for EoE, for example PPI and/or STC, during the course of the study, as long as background
- •medications have been stable for at least 8 weeks prior to the screening/run-in period (Visit 1) and there is agreement not to change
- •background medication or dosage unless medically indicated, during the screening/run-in and treatment period.
- •7. Participants currently leukotriene inhibitors and/or steroid treatments for asthma or allergies that are inhaled or administered intranasally,
- •must report a stable dose for at least 4 weeks prior to the screening/run-in period (Visit 1).
- •8. If a medication for EoE (including PPI and/or STC) is discontinued prior to the screening/run-in, there should be a washout period of at
- •least 8 weeks prior to Visit 1. Discontinuation of any marketed biologic (monoclonal or polyclonal antibody) should have a washout period of
- •4 months or 5 half-lives prior to Visit 1, whichever is longer.
- •9. Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 314
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, esophageal varices, Crohn's disease,
- •ulcerative colitis, inflammatory bowel disease, celiac disease, eosinophilic enteritis, colitis, diverticulitis, irritable bowel syndrome, or
- •other clinically significant gastrointestinal conditions as per Investigator discretion.
- •2.Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at
- •3. Use of a feeding tube, or having a pattern of not eating solid food = 3 days of the week. Solid food is defined as food that requires chewing before
- •swallowing.
- •4. Hypereosinophilic syndrome.
- •5. EGPA vasculitis
- •6. Esophageal dilation performed within 8 weeks prior to screening.
研究者
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