A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,281
- 试验地点
- 497
- 主要终点
- Percentage of Participants With Clinical Remission at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of UC for at least 3 months prior to baseline.
- •Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
- •Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
- •If female, must meet the contraception requirements.
排除标准
- •Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
- •Participants with a previous colectomy.
- •Participants with current evidence of toxic megacolon.
- •Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).
研究组 & 干预措施
300 Milligram (mg) Mirikizumab IV Q4W
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
干预措施: Mirikizumab (Drug)
Placebo Intravenous (IV) Every 4 Weeks (Q4W)
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
干预措施: Placebo (Drug)
Placebo IV Q4W Maximum Extended Enrollment (ME2)
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
干预措施: Placebo (Drug)
300 mg Mirikizumab IV Q4W ME2
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Remission at Week 12
时间窗: Week 12
Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability), excluding consideration of Physician's Global Assessment (PGA). Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The confidence interval of 99.88% was chosen to match the significance level.
次要结局
- Percentage of Participants With Clinical Response at Week 12(Week 12)
- Percentage of Participants With Endoscopic Remission at Week 12(Week 12)
- Percentage of Participants With Symptomatic Remission at Week 12(Week 12)
- Percentage of Participants With Symptomatic Response at Week 12(Week 12)
- Percentage of Participants With Histologic Remission at Week 12(Week 12)
- Percentage of Participants With Endoscopic Response at Week 12(Week 12)
- Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)(Baseline, Week 12)
- Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score(Baseline, Week 12)
- Change From Baseline to Week 12 in Fecal Calprotectin(Baseline, Week 12)
- Pharmacokinetics (PK): Clearance of Mirikizumab(Predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12)