Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Remission as measured by Modified Pouchitis Disease Activity Index (mPDAI)
研究概览
简要总结
The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are:
Does mirikizumab reduce symptoms of pouch disorders
Participants will:
Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Informed consent will be obtained before any study-related procedures
- •Age >/= 18 and </= 80 years
- •Diagnosis of Chronic Pouchitis or Crohn's-like disease of the pouch based on the following criteria:
- •Chronic Antibiotic-Dependent Pouchitis: Recurrent symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic discomfort) that respond to antibiotic therapy but relapse shortly after stopping antibiotics, thus necessitating continuous antibiotic therapy to achieve symptom control.
- •Chronic Antibiotic Refractory Pouchitis: Lack of response to standard antibiotic therapy, requirement of a longer duration of antibiotic therapy than expected with minimal improvement in symptoms, in association with typical symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic discomfort).
- •Crohn's-like disease of the pouch: Presence of a perianal or other fistula that developed at least 12 months after the final stage of Ileal Pouch Anal Anastomosis (IPAA) surgery, stricture of the pouch body or pre-pouch ileum, or the presence of pre-pouch ileitis. Pouch body inflammation (pouchitis) may often coexist in the setting of Crohn's-like disease of the pouch.
- •Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage IPAA and ileostomy takedown
- •Ability to access internet for electronic database entry
- •Only those individuals for whom a provider is considering initiating mirikizumab for the treatment of chronic pouchitis or Crohn's-like disease of the pouch will be eligible for participation.
排除标准
- •Prior exposure to mirikizumab
- •Known hypersensitivity to mirikizumab or its metabolites
- •Current infection with Clostridioides difficile
- •Known HIV or active Hepatitis B/C
- •Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's <1.5 upper limit of normal can be included)
- •Severe hepatic impairment, defined as Child-Pugh Class C
- •Known decreased kidney function with a glomerular filtration rate <45 ml/min/1.732
- •History of malignancy, except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to screening and no recurrence.
- •Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- •Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.
- •Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
研究组 & 干预措施
All patients
Open Label Mirikizumab
干预措施: Mirikizumab - Intravenous (IV) (Drug)
All patients
Open Label Mirikizumab
干预措施: Mirikizumab - Subcutaneous (SC) (Drug)
结局指标
主要结局
Remission as measured by Modified Pouchitis Disease Activity Index (mPDAI)
时间窗: Weeks 0, 24, and 52
The Pouchitis Disease Activity Index (PDAI) was developed for diagnosing active pouchitis and quantifying the severity of pouchitis. The PDAI includes the clinical criteria of 1) stool frequency 2) rectal bleeding 3) Fecal Urgency/Abdominal Cramps and 4) presence or absence of fever, endoscopic criteria, and histologic criteria through biopsies. The PDAI was modified to omit the biopsy and histology costs. The mPDAI includes the clinical portion and the endoscopic subscore of the PDAI. Score range is 0-12. The higher the score, the worse the disease activity. mPDAI remission is defined as an mPDAI score of 4 or lower and a reduction from baseline of 2 or more points in the mPDAI total score.
次要结局
- Median change in the Endoscopic Pouch Score (EPS)(Weeks 0, 24, and 52)
- Median change in the endoscopic subscore of the mPDAI(Weeks 0, 24, and 52)
- Change in Cleveland Clinic Global Quality of Life (QoL) scale(Weeks 0, 4, 8, 12, 24, 38, and 52)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) incontinence measures(Weeks 0, 4, 8, 12, 24, 38, and 52)
- Change in Urgency Numeric Rating Scale (NRS)(Weeks 0, 4, 8, 12, 24, 38, and 52)