A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-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
- 354
- 试验地点
- 406
- 主要终点
- Percentage of Participants Achieving Clinical Remission
研究概览
简要总结
The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
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
- Triple (Participant, Care Provider, 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
- •Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
- •Active UC confirmed by endoscopy
排除标准
- •Severe extensive colitis
- •Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
- •Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
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
时间窗: 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 electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \[\>=\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\<=) 1 (excluding friability). Each component sub-score 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 Symptomatic Remission(Week 12)
- Percentage of Participants Achieving Endoscopic Normalization(Week 12)
- Percentage of Participants Achieving Endoscopic Improvement(Week 12)
- Percentage of Participants Achieving Clinical Response(Week 12)
- Percentage of Participants Achieving Symptomatic Response(Weeks 2, 4, 8 and 12)
- Percentage of Participants With Mucosal Healing(Week 12)
- Percentage of Participants Achieving Non-invasive Clinical Response(Weeks 2, 4, 8 and 12)
- Percentage of Participants Achieving Symptomatic Remission at Weeks 2, 4 and 8(Weeks 2, 4 and 8)
- Percentage of Participants Achieving Complete Symptomatic Remission(Weeks 2, 4, 8 and 12)