A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active 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
- Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response
研究概览
简要总结
The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 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
- •Participants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:
- •Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1/glucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1/glucagon (Gcg) RAs, GLP-1/GIP/Gcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening
排除标准
- •Participants are excluded from the study if any of the exclusion criteria in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply:
- •Must not have a hepatic disease
- •Must not have a history of any other bone disease that affects bone metabolism
- •Must not have had any of the following within the past 180 days before screening:
- •acute myocardial infarction
- •cerebrovascular incident
- •hospitalization for unstable angina
- •hospitalization due to congestive heart failure, or
- •coronary revascularization
- •Must not have received or will need any other prohibited medications 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 - Intravenous (IV) (Drug)
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)
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
Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response
时间窗: Baseline, Up to Week 12
The percentage of participants who achieve endoscopic response at week 12 of Study Period 1.
次要结局
- Percentage of Participants who Achieve Clinical Remission(Baseline, Up to Week 12)
- Percent Change from Baseline in Fecal Calprotectin(Baseline, Up to Week 12)