A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants With Moderate to Severe Ulcerative Colitis in Clinical Practice
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 139
- 试验地点
- 85
- 主要终点
- Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 1 at Week 12
研究概览
简要总结
The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration
- •Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores:
- •i) An SF subscore ≥ 1, AND ii) An RB subscore ≥ 1, AND iii) An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration).
- •Report of a previous colonoscopy that documents extent of disease
排除标准
- •Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation
- •Extensive colonic resection or current stoma
- •Colonic dysplasia that has not been removed
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Cohort 1 - Advanced therapy-naive
干预措施: Ozanimod (Drug)
Cohort 2 - Advanced therapy-exposed
干预措施: Ozanimod (Drug)
结局指标
主要结局
Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 1 at Week 12
时间窗: At week 12
Clinical response is defined as meeting all of the following improvements from baseline in the Modified Mayo Score: * Decrease from baseline ≥ 2 points, * Decrease from baseline ≥ 35%, * Decrease from baseline in the Rectal Bleeding (RB) subscore ≥ 1 point or absolute RB subscore ≤ 1 The Modified Mayo Score is a tool that helps doctors measure how active ulcerative colitis is. It combines three components: * Stool Frequency (SF): scored 0-3 (higher score = more frequent stools), * Rectal Bleeding (RB): scored 0-3 (higher score = more bleeding), * Endoscopic Subscore (ES): scored 0-3 (higher score = more severe inflammation seen during endoscopy). The total score ranges from 0 to 9, with higher scores meaning more severe disease activity and lower scores meaning less disease activity and better clinical condition.
Percent of Participants Achieving Clinical Response Measured by Modified Mayo Score for Cohort 2 at Week 26
时间窗: At week 26
Clinical response is defined as meeting all of the following improvements from baseline in the Modified Mayo Score: * Decrease from baseline ≥ 2 points, * Decrease from baseline ≥ 35%, * Decrease from baseline in the Rectal Bleeding (RB) subscore ≥ 1 point or absolute RB subscore ≤ 1 The Modified Mayo Score is a tool that helps doctors measure how active ulcerative colitis is. It combines three components: * Stool Frequency (SF): scored 0-3 (higher score = more frequent stools), * Rectal Bleeding (RB): scored 0-3 (higher score = more bleeding), * Endoscopic Subscore (ES): scored 0-3 (higher score = more severe inflammation seen during endoscopy). The total score ranges from 0 to 9, with higher scores meaning more severe disease activity and lower scores meaning less disease activity and better clinical condition.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days))
- Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)(From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days))
- Number of Participants With Treatment Emergent Adverse Event of Interest(From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days))
- Number of Participants With Treatment Emergent Adverse Events Leading to Discontinuation(From first dose of study medication through post-medication follow-up visit (Up to approximately 812 days))
- Number of Participants With Clinically Significant Changes in Laboratory Assessments(From first dose of study medication through end of study (Up to approximately 728 days))
- Percent of Participants Achieving Clinical Remission by Partial Mayo Score at Week 52 and 104(At week 52 and week 104)
- Percent of Participants Achieving Corticosteroid-free Clinical Remission by Partial Mayo Score at Week 52 and 104(At week 52 and week 104)
- Percent of Participants Achieving Clinical Response by Partial Mayo Score at Week 52 and 104(At week 52 and week 104)
- Percent of Participants Achieving Clinical Remission Measured by Modified Mayo Score for Cohort 1 at Week 12(At week 12)
- Percent of Participants Achieving Endoscopic Response for Cohort 1 at Week 12(At week 12)
- Percent of Participants Achieving Endoscopic Improvement for Cohort 1 at Week 12(At week 12)
- Percent of Participants Achieving Histological Improvement for Cohort 1 at Week 12(At week 12)
- Change in the Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score From Baseline to Week 12 for Cohort 1(At baseline and week 12)
- Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response [Change in Total Score (≥16 Points) From Baseline to Week 12] for Cohort 1(At baseline and week 12)
- Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission [Total Score (≥170 Points)] for Cohort 1 at Week 12(At week 12)
- Percent of Participants Achieving Clinical Remission Measured by Modified Mayo Score for Cohort 2 at Week 26(At week 26)
- Percent of Participants Achieving Endoscopic Response for Cohort 2 at Week 26(At week 26)
- Percent of Participants Achieving Endoscopic Improvement for Cohort 2 at Week 26(At week 26)
- Percent of Participants Achieving Endoscopic Remission for Cohort 2 at Week 26(At week 26)
- Percent of Participants Achieving Histological Improvement for Cohort 2 at Week 26(At week 26)
- Percent of Participants Achieving Corticosteroid-free Clinical Remission by Modified Mayo Score for Cohort 2 at Week 26(At week 26)
- Percent of Participants Achieving Histological Remission for Cohort 2 at Week 26(At week 26)
- Change in the Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score From Baseline to Week 26 for Cohort 2(At baseline and week 26)
- Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response [Change in Total Score (≥16 Points) From Baseline to Week 26] for Cohort 2(At baseline and week 26)
- Percent of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission [Total Score (≥170 Points)] for Cohort 2 at Week 26(At week 26)
- Percent of Participants Achieving Histo-endoscopic Mucosal Improvement (HEMI) for Cohort 2 at Week 26(At week 26)