A Randomized, Double Blind, Placebo Controlled, 52 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 234
- 试验地点
- 283
- 主要终点
- Percentage of Participants Achieving Clinical Remission (CR) at Week 52 Using Modified Mayo Score (MMS)
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 active ulcerative colitis in adult participants.
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
- •Diagnosed with Ulcerative Colitis (UC) ≥ 3 months prior to screening
- •Active UC confirmed by endoscopy
- •Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score ≥ 2 and rectal bleeding score ≥ 1
- •Received a surveillance colonoscopy within 12 months before baseline
排除标准
- •Severe extensive colitis
- •Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
- •Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
- •Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening
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 (CR) at Week 52 Using Modified Mayo Score (MMS)
时间窗: Week 52
MMS is used to assess disease activity in participants with UC and has following components: endoscopic score(ES),rectal bleeding(RB),stool frequency(SF).Each component score ranges from 0 to 3(0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease.ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,scores ranged from 0(normal or inactive disease) to 3(severe disease \[spontaneous bleeding, ulceration\]).RB reported most severe amount of blood passed per rectum in 24-hour period,scores ranged from 0(no blood seen) to 3(blood alone passes).SF reported number of stools in 24-hour period relative to normal number of stools for that participant in same period,scores ranged from 0(normal number of stools) to 3(5 or more stools than normal).CR per FDA draft guidance defined as:SF=0 or 1 and no greater than baseline, RB=0,ES less than or equal to (\<=)1(excluding friability).Percentage of participants achieving CR at Week 52 was evaluated.
次要结局
- Percentage of Participants Achieving Clinical Remission at Week 12 Using MMS(Week 12)
- Percentage of Participants Achieving Endoscopic Improvement at Week 52(Week 52)
- Percentage of Participants Achieving Symptomatic Remission at Week 52(Week 52)
- Percentage of Participants Achieving Complete Symptomatic Remission at Week 52(Week 52)
- Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 52(Week 52)
- Percentage of Participants Achieving Clinical Remission at Both Weeks 12 and 52 [Combined] Using MMS(Weeks 12 and 52 [Combined])
- Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS(Week 52)
- Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS(Week 52)
- Percentage of Participants Achieving 4-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS(Week 52)
- Percentage of Participants With 4-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS(Week 52)
- Percentage of Participants Achieving Clinical Response at Week 12 Using MMS(Week 12)
- Percentage of Participants Achieving Clinical Response at Week 52 Using MMS(Week 52)
- Percentage of Participants Achieving Endoscopic Improvement at Week 12(Week 12)
- Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 12(Week 12)
- Percentage of Participants Achieving Symptomatic Remission at Week 12(Week 12)
- Percentage of Participants Achieving Complete Symptomatic Remission at Week 12(Week 12)
- Percentage of Participants Achieving Change From Baseline in Both ES and RB or in Both ES and SF at Week 12(Baseline to Week 12)
- Percentage of Participants Achieving Histologic Response Based on the Geboes Grading System at Week 12(Week 12)
- Percentage of Participants Achieving Histologic Response Based on Robarts Histopathology Index (RHI) at Week 12(Week 12)