J6E-MC-KWAM: 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)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 100
- 主要终点
- Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) [Time Frame: Week 10] Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 [Time Frame: Week 52]
研究概览
简要总结
-To evaluate if the 10-week induction efficacy of LY4268989 is superior to placebo as assessed by clinical remission in participants with moderately to severely active UC -To evaluate if the maintenance efficacy of LY4268989 is superior to placebo at Week 52 (Visit 208) as assessed by clinical remission among participants who achieve clinical response with LY4268989 at Week 10
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 symptomat
- •Have any prior or current evidence of cancer of the the gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancie
- •Have a diagnosis or history of malignant disease within 5 years prior to randomization
研究组 & 干预措施
MORF+Adipic Acid, MORF+Adipic Acid, null
干预措施: MORF+Adipic Acid (Drug)
Placebo to match LY
干预措施: Placebo to match LY (Drug)
MORF+Adipic Acid, MORF+Adipic Acid, null
干预措施: MORF+Adipic Acid, MORF+Adipic Acid, null (Drug)
结局指标
主要结局
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) [Time Frame: Week 10] Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 [Time Frame: Week 52]
Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS) [Time Frame: Week 10] Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10 [Time Frame: Week 52]
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.