NCT05644665终止3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Bristol-Myers Squibb51 个研究点 分布在 2 个国家目标入组 131 人开始时间: 2022年12月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 131
- 试验地点
- 51
- 主要终点
- Proportion of participants with clinical remission as measured by the 3-component Mayo Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ozanimod compared with placebo in participants with ulcerative colitis (UC) in mainland China and Taiwan. The main study is composed of an induction period, maintenance period, safety follow-up, and participants meeting certain criteria will be given the opportunity to participate in an optional open label extension.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Study:
- •Eligible participants must be Chinese.
- •Participant has had moderately to severely active UC diagnosed at least 3 months prior to first investigational product administration.
- •Open-label Extension Period:
- •Participants who have completed the Week 10 Visit and are non-responders at Week
- •Participants who have completed the Induction Period and entered the Maintenance Period experienced disease relapse during the Maintenance Period, or who have completed the Maintenance Period at Week 52.
排除标准
- •Main Study and Open-label Extension Period:
- •Participant has severe extensive colitis, diagnosis of CD, indeterminate colitis, presence or history of a fistula consistent with CD, microscopic colitis, radiation colitis, or ischemic colitis.
- •Open-label Extension Period:
- •Participant has clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the participant at risk by continuing the study or that would have required a participant to discontinue treatment were observed during the Induction Period or Maintenance Period.
- •Participant has clinically relevant cardiovascular conditions, including history or presence of recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, Class III/IV heart failure, sick sinus syndrome, or severe untreated sleep apnea were observed during the Induction Period or Maintenance Period.
研究组 & 干预措施
Arm A: Ozanimod
Experimental
干预措施: Ozanimod (Drug)
Arm B: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants with clinical remission as measured by the 3-component Mayo Score
时间窗: At week 10
次要结局
- Proportion of participants achieving histologic remission(At week 10 and at week 52)
- Proportion of participants with mucosal healing(At week 10 and at week 52)
- Proportion of participants with clinical laboratory abnormalities(Up to 78 weeks)
- Proportion of participants with electrocardiogram (ECG) abnormalities(Up to 78 weeks)
- Proportion of participants with clinical response as measured by the 3-component Mayo Score(At week 10 and at week 52)
- Proportion of participants with pulmonary function test abnormalities(Up to 78 weeks)
- Proportion of participants in remission as measured by the 3-component Mayo Score while off corticosteroids for ≥ 12 weeks(At week 52)
- Proportion of participants with clinical remission as measured by the 3-component Mayo Score(At week 52)
- Proportion of participants with Treatment Emergent Adverse Events (TEAEs)(Up to 78 weeks)
- Proportion of participants with vital sign abnormalities(Up to 78 weeks)
- Proportion of participants with endoscopic improvement(At week 10 and at week 52)
- Proportion of participants with Serious Adverse Events (SAEs)(Up to 78 weeks)
- Proportion of participants with TEAEs leading to discontinuation of investigational product(Up to 78 weeks)
- Proportion of participants with TEAEs of special interest(Up to 78 weeks)
研究者
研究点 (51)
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