A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 134
- 主要终点
- Change From Baseline in Adapted Mayo Score (MCS) at Week 12
研究概览
简要总结
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for 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
- Triple (Participant, Care Provider, 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
- •Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score
- •Evidence of colonic ulcerative colitis activity on endoscopy
排除标准
- •Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol
- •Within 60 days prior to randomization, receipt of any of the following: Infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent
- •Any prior exposure to natalizumab, efalizumab, or rituximab
研究组 & 干预措施
Etrasimod Low Dose
Oral, low dose, daily for 12 Weeks
干预措施: Etrasimod (Drug)
Etrasimod High Dose
Oral, high dose, daily for 12 weeks
干预措施: Etrasimod (Drug)
Placebo
Oral, placebo, daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Adapted Mayo Score (MCS) at Week 12
时间窗: Baseline and Week 12
The adapted MCS was used to measure disease activity of ulcerative colitis. It consisted of 3 subscores (stool frequency, rectal bleeding, and findings of endoscopy), each of which was rated on a scale from 0 to 3, indicating normal to severe. The adapted MCS was calculated as the sum of the 3 subscores, and the overall score values ranged from 0 to 9, with a higher score indicating more severe disease. Multiple imputation method was used to handle missing data.
次要结局
- Percentage of Participants Who Achieved Endoscopic Improvement at Week 12(Week 12)
- Change From Baseline in Total Mayo Score (TMS) at Week 12(Baseline and Week 12)
- Change From Baseline in 2-component MCS at Week 12(Baseline and Week 12)