A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 290
- 试验地点
- 183
- 主要终点
- Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.
The maximum duration of this study is up to 61 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
- Double (Participant, Investigator)
盲法说明
Mirikizumab will be open label, tirzepatide and placebo to match will be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD
- •Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to <30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions:
- •hypertension
- •Type 2 diabetes mellitus (T2DM)
- •dyslipidemia
- •obstructive sleep apnea, or
- •cardiovascular disease.
- •Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.
- •Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.
- •Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline.
- •Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy
排除标准
- •Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
- •Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.
- •Currently have or are suspected to have an abscess.
- •Have a stoma, ileoanal pouch, or ostomy.
- •Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.
- •Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
- •Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
- •Have had more than 5% body weight change in the past 3 months
- •Have a current or recent acute, active infection.
研究组 & 干预措施
Mirikizumab + Tirzepatide
Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC).
Tirzepatide administered SC.
干预措施: Tirzepatide (Drug)
Mirikizumab + Placebo
Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
干预措施: Mirikizumab (Drug)
Mirikizumab + Placebo
Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
干预措施: Placebo (Drug)
Mirikizumab + Tirzepatide
Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC).
Tirzepatide administered SC.
干预措施: Mirikizumab (Drug)
结局指标
主要结局
Percentage of Participants Who Simultaneously Achieve Clinical Remission by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction
时间窗: Week 52
Percentage of participants who simultaneously achieve clinical remission by CDAI, endoscopic remission and at least 10% weight reduction.
次要结局
- Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI(Week 52)
- Percentage of Participants Who Achieved Maintenance of Endoscopic Remission(Week 52)
- Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight(Week 52)
- Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission(Week 24, 52)
- Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI(Week 52)
- Percentage of Participants Who Achieved Maintenance of Endoscopic Remission(Week 52)
- Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission by CDAI Among Participants Who Used Corticosteroids at Baseline(Week 52)
- Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)(Baseline, Week 52)
- Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight(Week 52)