Moving Beyond Inflammation as a Therapeutic Target for 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
- 3
- 主要终点
- Proportion and number of participants who have treatment emergent adverse events, serious adverse events, discontinuation of study intervention due to adverse events and injection-site reactions by CTCAE v4.0
研究概览
简要总结
The purpose of this research study is to evaluate what type of treatment will be beneficial for people with Crohn's disease and difficult to treat inflammation in the small bowel. Current therapies are used to control the inflammation due to Crohn's disease in your digestive tract. In some patients, those therapies are not sufficient to fully treat the disease. This objective of this study is to evaluate the efficacy of a different type of therapy, tirzepatide, that may promote healing of the affected intestinal segment. To evaluate the efficacy of this medication, a member of the research team will ask patients questions about how they feel and observe whether this medication heals the their bowel at colonoscopy. A member of the research team will also use blood samples, stool samples and samples of the small intestine taken during a colonoscopy to understand how tirzepatide helps heal the intestine.
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
- •Subjects 18 to 80 years of age, inclusive, at the time of consent
- •Confirmed diagnosis of Crohn's disease based on documented findings on endoscopy and histopathology
- •Active ileal or ileocolonic inflammation on colonoscopy defined as
- •1. Ileal SES-CD > 4 with ulcer subscore > 1 (ulcers > 5mm)
- •Failure to respond to (primary or secondary non-response) at least 2 advanced class drugs, without evidence of immunogenicity (anti-TNFa only). Must have been at least 6 months optimized on most recent therapy without corticosteroids.
- •Anti-TNF: Infliximab, Adalimumab, Certolizumab, Golimumab
- •Anti-integrin agent: vedolizumab
- •Anti-IL12/23 agent: Ustekinumab
- •Anti-IL23: Risankizumab, Guselkumab, Mirikizumab
- •JAK inhibitor: Upadacitinib
- •In post surgical patients, must be at least 6 months post-op with endoscopic evidence of ileal disease
- •In females: compliance to recommended birth control requirements
排除标准
- •Age < 18 or > 80 years
- •Pregnant or Breastfeeding female
- •Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, active infectious colitis or positive test for Clostridioides Difficile toxin at screening
- •Current or previous diagnosis of anorexia nervosa
- •Type 1 or Type 2 diabetes
- •Use of concomitant hypoglycemic agents
- •Personal or family history of medullary thyroid carcinoma
- •History of multiple endocrine neoplasia
- •Known serious hypersensitivity to tirzepatide or any of its excipients
- •Have functional or post-operative short-bowel syndrome
- •Had intestinal resection ≤ 24 weeks prior to inclusion or other intra-abdominal surgeries ≤ 12 weeks prior to study inclusion
- •Active treatment with steroids*
- •Positive stool test for parasites, C. Diff or stool culture for pathologic bacteria within 30 days prior to enrollment
- •Current stricture not passable with an endoscope
- •Impending need for surgery per investigator
- •Have an ileostomy or a colostomy
- •In females: refusal to comply to recommended birth control requirements *Corticosteroids have metabolic and hormonal effects which we are concerned may interfere with study outcomes and metabolic changes in the population. This exclusion criteria will allow the study population to be standardized across all patients
研究组 & 干预措施
Standard of Care Arm
干预措施: Standard of care treatment (Drug)
Tirzepatide group
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Proportion and number of participants who have treatment emergent adverse events, serious adverse events, discontinuation of study intervention due to adverse events and injection-site reactions by CTCAE v4.0
时间窗: From enrollment to the end of treatment at month 7
Number of participants who achieve various doses of Tirzepatide at increments of 2.5 mg, up to 15 mg
时间窗: From enrollment to the end of treatment at month 7
Proportion and number of participants with endoscopic remission as defined by SES-CD < 4 with no ulcer subscore >1.
时间窗: From enrollment to the end of treatment at month 7
次要结局
- Proportion and number of participants with endoscopic response as defined by (↓SES-CD 50%)(From enrollment to the end of treatment at month 7)
- Proportion and number of participants who achieve clinical remission/response defined by Crohn's disease activity index < 150 for clinical remission or a decrease from baseline by at least 100 points on CDAI(From enrollment to the end of treatment at month 7)
- Proportion and number of participants who achieve clinical remission defined by a Harvey Bradshaw Index < 5(From enrollment to the end of treatment at month 7)
- Proportion and number of participants who achieve improvement from baseline in the Short Inflammatory Bowel Disease Quality of Life Questionnaire in four domains, bowel symptoms, emotional health, systemic systems and social function. Questions are score(From enrollment to the end of treatment at month 7)
- Proportion and number of participants who achieve improvement from baseline in visceral adipose tissue, the total body fat percentage, fat mass index by DEXA(From enrollment to the end of treatment at month 7)
- Rates of remission in each group (3rd advanced therapy, tirzepatide 5mg dosing, tirzepatide escalated dosing)(From enrollment to the end of treatment at month 7)