2023-504277-20-00招募中3 期
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 211
- 试验地点
- 53
- 主要终点
- 1. Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels at Week 24
研究概览
简要总结
-
To evaluate the effect of tezepelumab on the histologic response in adult and adolescent participants with symptomatic and histologically active EoE
-
To evaluate the effect of tezepelumab on symptom improvement in adult and adolescent participants with symptomatic and histologically active EoE
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Safety follow-up period
- 盲法
- Double (Subject, Monitor, Carer, Analyst, Investigator)
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 0-17 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participant must be 12 to 80 years of age inclusive, at the time of signing the informed consent/assent.
- •Weight ≥ 40 kg at Visit 1
- •Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming a diagnosis of EoE.
- •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
- •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).
- •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.
- •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).
- •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
- •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.
- •Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet
排除标准
- •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.
- •Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
- •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
- •Hypereosinophilic syndrome.
- •EGPA vasculitis.
- •Esophageal dilation performed within 8 weeks prior to screening.
结局指标
主要结局
1. Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels at Week 24
1. Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels at Week 24
2. Change from baseline in DSQ score at Week 24
2. Change from baseline in DSQ score at Week 24
次要结局
- 1. Change from baseline in EoE EREFS at Week 24 and Week 52
- 2. Change from baseline in EoE-HSS grade score at Week 24 and Week 52
- 3. Change from baseline in EoE-HSS stage score at Week 24 and Week 52
- 4. Histologic response of peak esophageal eosinophil per HPF count of ≤ 6 across all available esophageal levels at Week 52
- 5. Change from baseline in DSQ score at Week 52
- 6. Endoscopic response of total EREFS score of 0 to ≤ 2 with no score > 1 for any of the components and no worsening in any individual component from baseline across all esophageal levels (ie, proximal, mid, and distal) at Week 52
- 7. Endoscopic inflammatory remission of EREFS inflammatory subscore (including edema, exudate, and furrows components) of 0 with no worsening in rings or stricture from baseline across all esophageal levels at Week 52.
- 8. Total endoscopic remission of total EREFS score of 0 across all esophageal levels at Week 52.
- 9. Change from baseline in peak esophageal eosinophil count (EOS/HPF) at Week 24 and Week 52
- 10. Changes from baseline in PEESS Module at Week 24 and Week 52 (adolescents only)
- 11. Serum trough concentrations at Weeks 0, 4, 12, and 52
- 12. Anti-drug antibody at Weeks 0, 12, 24, and 52
研究者
AZ Clinical Study Info Center
Scientific
AstraZeneca AB
研究点 (53)
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