A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 70
- 主要终点
- Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
研究概览
简要总结
Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.
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
- None
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
- •Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.
- •Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit
- •Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤)
- •Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization
- •Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD
- •Have screening laboratory test results within the protocol specified parameters.
排除标准
- •Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis
- •For UC - must not have a current diagnosis of CD
- •For CD - must not have a current diagnosis of UC
- •Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol
- •Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome
- •Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data
- •Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action
- •Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment
- •Must not have received or will need any prohibited medications for UC or CD as specified in the protocol
研究组 & 干预措施
Mirikizumab
Study Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
干预措施: Mirikizumab - Subcutaneous (SC) (Drug)
LY4395089 and Mirikizumab Co-Administration
Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
干预措施: LY4395089 (Drug)
Mirikizumab
Study Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
干预措施: Mirikizumab - Intravenous (IV) (Drug)
LY4395089 and Mirikizumab Co-Administration
Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
干预措施: Mirikizumab - Intravenous (IV) (Drug)
LY4395089 and Mirikizumab Co-Administration
Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
干预措施: Mirikizumab - Subcutaneous (SC) (Drug)
结局指标
主要结局
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
时间窗: Baseline, Up to Day 42
次要结局
未报告次要终点