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临床试验/NCT05061446
NCT05061446已完成2 期

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

Pfizer79 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2021年9月10日最近更新:
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
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

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

Experimental

干预措施: Etrasimod (Drug)

Etrasimod Dose 2

Experimental

干预措施: Etrasimod (Drug)

Placebo

Placebo Comparator

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)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (79)

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