A Phase 3, Double-Blind, Placebo-Controlled, 40-Week Extension Study to Assess the Efficacy and Safety of Etrasimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 42
- 试验地点
- 38
- 主要终点
- Percentage of Participants Achieving Clinical Remission at Week 40 of Study APD334-308
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 in adult Japanese participants with moderately to severely active ulcerative colitis (UC). This study is an extension of study APD334-302 (NCT03996369). Participants will continue with the same blinded treatment assigned in Study APD334-302 for a total treatment duration of 52 weeks (12 weeks in Study APD334-302 plus 40 weeks in Study APD334-308).
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
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with moderately to severely active ulcerative colitis (UC) are eligible to enroll into this study if they fulfill all of the following:
- •Must have completed the Week 12 visit of Study APD334-302
- •Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a participant < 20 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments. Enrollment of participants < 20 years should be conducted only if acceptable according to local laws and regulations.
- •Both men and women subjects agree to use a highly effective method of birth control if the possibility of conception exists
排除标准
- •Participants who meet any of the following exclusion criteria will not be eligible for enrollment into the study:
- •If the Investigator considers the participant to be unsuitable for any reason to participate in the study
- •Participants requiring partial or total colectomy during the APD334-302 study
- •Participants requiring treatment with prohibited concomitant medications
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 at Week 40 of Study APD334-308
时间窗: Week 40 of APD334-308
Clinical remission was based on the modified Mayo score (MMS). The MMS is a composite score of 3 assessments consisting of participant-reported symptoms using daily electronic (e)-diary and centrally read endoscopy: stool frequency (SF), rectal bleeding (RB) and endoscopic score (ES). Clinical remission was defined as SF sub-score = 0 (or = 1 with a greater than or equal to \[\>=\] 1-point decrease from Baseline), RB sub-score = 0, and ES less than or equal to (\<=) 1 (excluding friability). Each component sub-score ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
次要结局
- Percentage of Participants Achieving Sustained Clinical Remission(Week 40 of APD334-308)
- Percentage of Participants, Who Had Not Been Receiving Corticosteroids for ≥ 12 Weeks, Achieving Clinical Remission at Week 40 of Study APD334-308 Among Participants Receiving Corticosteroids at C5041015 (APD334-302) Study Entry(Week 40 of APD334-308)
- Percentage of Participants Achieving Endoscopic Improvement at Week 40 of Study APD334-308(Week 40 of APD334-308)
- Percentage of Participants Achieving Symptomatic Remission at Week 40 of Study APD334-308(Week 40 of APD334-308)
- Percentage of Participants With Mucosal Healing at Week 40 of Study APD334-308(Week 40 of APD334-308)