NCT05767021已完成3 期
A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 238
- 主要终点
- Change From Baseline in Bowel Urgency Severity Urgency Numeric Rating Scale (UNRS)
研究概览
简要总结
A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an established diagnosis of UC for ≥3 months
- •Have confirmed diagnosis of moderately for severely active UC
- •Have current bowel urgency
- •Have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for UC.
排除标准
- •Have Crohn's disease (CD)
- •Have inflammatory bowel disease-unclassified, formerly known as indeterminate colitis, or
- •Have ulcerative proctitis, disease limited to the rectum, that is, distal to the recto-sigmoid junction, which lies approximately 10 to 15 centimeter (cm) from anal verge.
- •Have an inherited immunodeficiency syndrome or a monogenic cause of UC-like colonic inflammation
- •Have any history or current evidence of cancer of the gastrointestinal tract
- •Have active tuberculosis
- •Have HIV infection.
研究组 & 干预措施
300 mg Mirikizumab
Experimental
Participants received 300 milligram (mg) mirikizumab every 4 weeks (Q4W) at week 0, 4, and 8 administered intravenously (IV).
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Change From Baseline in Bowel Urgency Severity Urgency Numeric Rating Scale (UNRS)
时间窗: Baseline, Week 12
The UNRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicate more severe urgency. Baseline Observation Carried Forward (BOCF) endpoint was defined as the baseline value for participants discontinued during acute phase and defined as the last non-missing observation in the treatment phase for all other randomized participants.
次要结局
- Change From Baseline in Bowel Urgency Frequency (BUF)(Baseline, Week 12)
- Percentage of Participants Achieving Clinically Meaningful Improvement in BUF(Baseline to Week 12)
- Percentage of Participants With Stool Deferral Time (SDT) Intervals at Week 12(Week 12)
- Percentage of Participants Achieving Both Clinical Remission, Based on the Modified Mayo Score (MMS) and a Rounded Urgency Numeric Rating Scale (UNRS) Score of ≤1(Week 12)
- Percentage of Participants Achieving Both Clinical Response, Based on the Modified Mayo Score (MMS) and a Rounded Urgency Numeric Rating Scale (UNRS) Score ≥3 Points of Improvement From Baseline(Week 12)
- Correlation Between Change From Baseline in Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF), Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures, With QoL/Functional Outcome Measures and UC Symptom Measures(Baseline, Week 12 UC symptom measures:Patient Global Rating of Severity (PGR-S)(1-6),Patient Global Impression of Change (PGI-C)(1-7),Mayo SF/RB (0-3),Abdominal pain/fatigue NRS (0-10),nocturnal stool frequency; higher=worse severity for all measures.)
- Percentage of Participants Achieving Clinically Meaningful Improvement of SDT(Week 12)
- Pairwise Correlations Between the Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF), Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures(Baseline to Week 12)
- Pairwise Correlations Between Change From Baseline in Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF), Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures(Baseline, Week 12)
- Correlation Between Urgency Numeric Rating Scale (UNRS), Baseline in Bowel Urgency Frequency (BUF),Stool Deferral Time (SDT) and Absorbent Product Use (APU) Measures,With Quality of Life (QoL)/Functional Outcome Measures and UC Symptom Measures(Baseline to Week 12 UC symptom measures:Patient Global Rating of Severity (PGR-S)(1-6),Patient Global Impression of Change (PGI-C)(1-7),Mayo SF/RB (0-3),Abdominal pain/fatigue NRS (0-10),nocturnal stool frequency;higher=worse severity for all measures.)
研究者
研究点 (238)
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