A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 433
- 试验地点
- 312
- 主要终点
- Percentage of Participants Achieving Clinical Remission at Week 12
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 moderately to severely active ulcerative colitis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Etrasimod 2 mg
干预措施: Etrasimod (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Clinical Remission at Week 12
时间窗: At Week 12
Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily eDiary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Percentage of Participants Achieving Clinical Remission at Week 52
时间窗: At Week 52
Clinical remission was based on the MMS which is a composite score of 3 assessments: SF, RB and ES. Clinical remission was defined as SF subscore = 0 (or = 1 with a ≥ 1-point decrease from Baseline), RB subscore = 0, and ES ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
次要结局
- Percentage of Participants Achieving Endoscopic Improvement at Week 12(At Week 12)
- Percentage of Participants Achieving Symptomatic Remission at Week 52(At Week 52)
- Percentage of Participants With Mucosal Healing at Week 12(At Week 12)
- Percentage of Participants Achieving Symptomatic Remission at Week 12(At Week 12)
- Percentage of Participants With Mucosal Healing at Both Weeks 12 and 52(At Weeks 12 and 52)
- Percentage of Participants Achieving Symptomatic Remission by Study Visit(At Weeks 2, 4, 8, 16, 20, 24, 32, 40, and 48)
- Percentage of Participants Achieving Clinical Response at Week 52(At Week 52)
- Percentage of Participants Achieving Clinical Response at Both Weeks 12 and 52(At Weeks 12 and 52)
- Percentage of Participants Achieving Endoscopic Normalization at Week 12(At Week 12)
- Percentage of Participants Achieving Non-invasive Clinical Response by Study Visit(At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Percentage of Participants Achieving Endoscopic Improvement at Week 52(At Week 52)
- Percentage of Participants With Mucosal Healing at Week 52(At Week 52)
- Percentage of Participants Achieving Sustained Clinical Remission at Both Weeks 12 and 52(At Weeks 12 and 52)
- Percentage of Participants Achieving Clinical Response at Week 12(At Week 12)
- Percentage of Participants Achieving Endoscopic Normalization at Week 52(At Week 52)
- Percentage of Participants Achieving Endoscopic Normalization at Both Weeks 12 and 52(At Weeks 12 and 52)
- Percentage of Participants Achieving Complete Symptomatic Remission by Study Visit(At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48 and 52)
- Percentage of Participants Achieving Symptomatic Response by Study Visit(At Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52)
- Percentage of Participants Achieving Clinical Remission at Week 52 Among Participants in Clinical Response at Week 12(At Week 52)
- Percentage of Participants Achieving Corticosteroid-free Clinical Remission at Week 52(At Week 52)
- Percentage of Participants Achieving 4-week Corticosteroid-free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline(At Week 52)