NCT04682639已完成2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects With Eosinophilic Esophagitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 108
- 试验地点
- 252
- 主要终点
- Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
研究概览
简要总结
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for active eosinophilic esophagitis (EoE) in adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an eosinophilic esophagitis (EoE) diagnosis prior to screening and histologically active disease with an esophageal peak eosinophil count (PEC) of ≥ 15 eosinophils per high powered field (eos/hpf)
- •Have dysphagia, defined as solid food going down slowly or getting stuck in the throat with an average frequency of ≥ 2 episodes per week over 2 weeks during the Screening period
- •Inclusion Criteria for the Extension Treatment Period
- •Completion of the Week 24 study visit [including esophagogastroduodenoscopy (EGD)]
- •Compliance with study procedures during the Double-Blind Treatment Period as assessed by the Investigator
- •No notable safety concerns during the Double-Blind Treatment Period, as determined by the Investigator
- •Willing to comply with all study visits and procedures for the Extension Treatment Period
排除标准
- •History of any of the non-EoE conditions or procedures that may interfere with the evaluation of or affect the histologic (eg eosinophilic gastritis), endoscopic (eg, high-grade esophageal stenosis), or symptom endpoints (eg, esophageal resection) of the study
- •Undergone dilation of an esophageal stricture within 12 weeks prior to Screening EGD
- •Use of corticosteroids for the treatment of EoE within 8 weeks prior to Screening EGD
- •Discontinue, initiate, or change dosing (dosage/frequency) of the following therapies for EoE within 8 weeks prior to Screening EGD. Participants on any of the following therapy need to stay on a stable regimen during study participation:
- •Elemental diet
- •EoE food trigger elimination diet
- •Proton pump inhibitor (PPI) therapy
- •Used any immunotherapy/desensitization including oral immunotherapy (OIT) or sublingual immunotherapy (SLIT) within 12 months prior to the Screening EGD. Note: Stable (ie, ≥ 6 months prior to the Screening EGD) subcutaneous immunotherapy (SCIT) is permitted. Participants on SCIT need to stay on a stable treatment during study participation
- •Used any protocol-specified immunomodulatory therapies within the protocol-specified timeframe prior to Baseline (eg, dupilumab, benralizumab, omalizumab, or infliximab within 12 weeks; a sphingosine-1-phosphate receptor modulator at any time)
- •Use of any investigational agent or device within 12 weeks prior to Baseline
- •Females who are pregnant
研究组 & 干预措施
Etrasimod Dose 1
Experimental
干预措施: Etrasimod (Drug)
Etrasimod Dose 2
Experimental
干预措施: Etrasimod (Drug)
Placebo and Etrasimod
Placebo Comparator
Participants will receive etrasimod matching placebo tablet during the Double-Blind Treatment Period and etrasimod tablet during the Extension Treatment Period.
干预措施: Placebo (Drug)
Placebo and Etrasimod
Placebo Comparator
Participants will receive etrasimod matching placebo tablet during the Double-Blind Treatment Period and etrasimod tablet during the Extension Treatment Period.
干预措施: Etrasimod (Drug)
结局指标
主要结局
Percent Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16
时间窗: Baseline, Week 16
Eosinophils was counted in the areas of greatest eosinophil density. Counts were reported as the number of eosinophils/high power field (eos/hpf) and multiple hpfs analyzed until the PEC was clearly identified after taking into account all biopsies from all esophageal levels.
次要结局
- Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Score at Week 16(Baseline, Week 16)
- Percentage Of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than (<) 15 Eosinophils/High Power Field (Eos/Hpf) at Week 16(Week 16)
- Absolute Change From Baseline in Esophageal Peak Eosinophil Count (PEC) at Week 16(Baseline, Week 16)
- Percentage of Participants With Esophageal Peak Eosinophil Count (PEC) Less Than or Equal to (<=) 6 Eosinophils/High Power Field (Eos/Hpf) at Week 16(Week 16)
研究者
研究点 (252)
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