NCT07415044招募中2 期
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,431
- 试验地点
- 309
- 主要终点
- Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10
研究概览
简要总结
The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally.
The study will last up to approximately 108 weeks, excluding screening.
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, Care Provider)
盲法说明
Non-responders at week 10 will receive Open Label LY4268989 in maintenance study
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
- •Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC
- •Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1
- •Have evidence of UC extending proximal to the rectum
- •Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years
- •Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded
- •Must meet contraception requirements
排除标准
- •Have a current diagnosis of
- •Crohn's disease
- •Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or
- •primary sclerosing cholangitis
- •Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation
- •Have had or will need bowel resection or intestinal or intra-abdominal surgery
- •Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic
- •Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies
- •Have a diagnosis or history of malignant disease within 5 years prior to randomization
研究组 & 干预措施
LY4268989 Study Dose 1
Experimental
LY4268989 administered orally
干预措施: LY4268989 (Drug)
LY4268989 Study Dose 2
Experimental
LY4268989 administered orally
干预措施: LY4268989 (Drug)
Placebo Study Dose
Placebo Comparator
Placebo administered orally
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10
时间窗: Week 52
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)
时间窗: Week 10
次要结局
- Percentage of Participants Who Achieve Symptomatic Response Among Participants Who Achieved Clinical Response with LY4268989 at Week 10(Week 10 Up to Week 52)
- Pharmacokinetics (PK): Plasma Concentrations of LY4268989(Baseline Up to Approximately Week 52)
- Percentage of Participants Who Achieve Clinical Remission Among Participants Who Achieved Clinical Remission with LY4268989 at Week 10(Week 52)
- Percentage of Participants Who Achieve Clinical Response with mMS(Week 10)
- Percentage of Participants Who Achieve Clinical Response with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10(Week 10 Up to Week 52)
- Percentage of Participants Who Achieve Symptomatic Response(Baseline Up to Week 8)
研究者
研究点 (309)
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