A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 12-Week Dose-Ranging Study to Assess the Efficacy and Safety of Etrasimod in Japanese Participants With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 54
- 试验地点
- 79
- 主要终点
- Percentage of Participants Who Achieved Clinical Remission at Week 12
研究概览
简要总结
The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.
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
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese ancestry
- •Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
- •Having active UC confirmed by endoscopy
- •Moderately to severely active UC
排除标准
- •Severe extensive colitis
- •Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence, history of a fistula consistent with CD
- •Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
研究组 & 干预措施
Etrasimod Dose 1
干预措施: Etrasimod (Drug)
Etrasimod Dose 2
干预措施: Etrasimod (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Clinical Remission at Week 12
时间窗: Week 12
Clinical remission:Participants with stool frequency (SF)subscore=0(or of 1 with greater than or equal to(\>=)1 point decrease from baseline,rectal bleeding(RB)subscore=0 and endoscopic score(ES)less than or equal to(\<)=1(excluding friability).SF subscore:number of stools in 24-hours relative to normal number of stools for that participant in same period,score ranged from 0(normal number of stools) to 3(5 or more stools than normal),higher scores=more severity.RB subscore:most severe amount of blood passed per rectum in 24-hours,score ranged from 0(no blood seen)to 3(blood alone passes),higher scores=more severity.ES:reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,score ranged from 0(normal or inactive disease) to 3(severe disease \[spontaneous bleeding,ulceration\]),higher scores=more severity.Modified Mayo score:measure disease activity for UC,score:0(normal) to 9(maximum severity),comprised subscores for SF,RB,ES.higher score=more severe disease activity.
次要结局
- Percentage of Participants Who Achieved Endoscopic Improvement at Week 12(Week 12)
- Percentage of Participants Who Achieved Symptomatic Remission at Week 12(Week 12)
- Percentage of Participants Who Achieved Mucosal Healing at Week 12(Week 12)
- Percentage of Participants Who Achieved Clinical Response at Week 12(Week 12)
- Percentage of Participants Who Achieved Endoscopic Normalization at Week 12(Week 12)
