NCT05907330尚未招募2 期
A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase 2 Study to Evaluate the Efficacy and Safety of CU104 in Patients With Moderate to Severe Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Percentage of participants with clinical remission at Week 8
研究概览
简要总结
The study is designed to investigate efficacy and safety of CU104 in patients with moderate to severe ulcerative colitis.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged 18 to 80 years.
- •Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to Screening.
- •Active, moderate to severe ulcerative colitis, as defined by the modified Mayo score of 5 to 9, including an endoscopy sub-score of at least
- •For females of reproductive potential: Use of highly effective contraception for at least 1 month prior to Screening and agreement to use such method during study participation and for an additional 8 weeks after the last dose.
- •For males of reproductive potential: Use of condoms or other methods to ensure effective contraception during study participation and for an additional 8 weeks after the last dose.
排除标准
- •Received any of the following, prior to randomization for the treatment of UC:
- •Corticosteroids (intravenous or rectal administration) or 5-aminosalicylic acid (rectal administration) within 3 weeks;
- •Janus kinase (JAK) inhibitors within 2 weeks;
- •Cyclosporine, mycophenolate, tacrolimus, methotrexate, azathioprine, or 6- mercaptopurine within 4 weeks;
- •Anti-TNF-α biologics within 8 weeks; or
- •Any other commercially approved biologic agent or targeted small molecule within 8 weeks or within 5 half-lives whichever is longer.
- •Have been diagnosed with UC limited to the rectum (disease which extends < 15 cm above the anal verge).
- •Received orally administered 5-aminosalicylic acid (ASA), sulfasalazine, or low-dose corticosteroids (prednisolone ≤20 mg/day or its equivalent) on a stable regimen (i.e., no changes in drug or dose) for <4 weeks prior to randomization. The doses must remain stable until the end of study treatment (with possible exception for tapering steroid dose after 8 weeks).
- •Received any other concomitant medications for UC on a stable regimen (i.e., no changes in drug or dose) for <2 weeks or 5 half-lives, whichever is longer.
- •Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic megacolon.
- •Previous extensive colonic resection (subtotal or total colectomy).
- •Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- •Evidence of or treatment for, Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to randomization.
- •Active viral infection with HIV, Hepatitis B, or Hepatitis C.
- •Clinically significant, active extraintestinal infection (e.g., pneumonia, pyelonephritis).
- •History of cancer, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
- •History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study (e.g., End-stage renal disease (ESRD), severe liver diseases).
- •Has unstable angina, myocardial infarction, transient ischemic attack, cerebral infarction, coronary artery bypass surgery, or transluminal coronary angioplasty within 6 months before screening.
- •Other clinically significant abnormal lab values per Investigator's judgement.
- •Pregnancy or lactation.
- •Treatment with another investigational drug or other intervention within 30 days prior to Screening.
研究组 & 干预措施
CU104
Experimental
CU104 100 mg three capsules a day .
干预措施: CU104 (Drug)
Placebo
Placebo Comparator
Placebo three capsules a day.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of participants with clinical remission at Week 8
时间窗: Week 8
Clinical remission is defined as a modified Mayo score o to 2
次要结局
未报告次要终点
研究者
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