NCT03950232进行中（未招募）3 期
An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 896
- 试验地点
- 911
- 主要终点
- Number and Severity of Safety Measures
研究概览
简要总结
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:
- •Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
- •Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit
排除标准
- •If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
- •Experienced an adverse event that led to discontinuation from parent study
研究组 & 干预措施
Etrasimod 2 mg
Experimental
干预措施: Etrasimod (Drug)
结局指标
主要结局
Number and Severity of Safety Measures
时间窗: Up to approximately 8 years
Safety as assessed by the evaluation of adverse events
次要结局
- Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores(Week 52 and Week 104)
- Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores(Week 52 and Week 104)
- Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores(Week 52 and Week 104)
- Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry(Week 52 and Week 104)
- Change From Baseline in Partial Mayo Score(Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260)
- Change From Baseline in the Total Mayo Score(Baseline, Week 52, and Week 104)
研究者
研究点 (911)
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