A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 45
- 主要终点
- Rate of clinical remission
研究概览
简要总结
The purpose of this study is to determine whether Phosphatidylcholine (LT-02) add on treatment is effective and safe for the induction of remission in ulcerative colitis patients refractory to standard treatment with mesalamine
详细描述
A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of LT-02 (delayed release phosphatidylcholine granules; administered orally via 1.6 g BID for up to 12 weeks) in subjects with active ulcerative colitis who are refractory to a standard dose of oral mesalamine therapy. Refractory to mesalamine is defined as active disease despite receiving at least ≥ 2.4g mesalamine (or equivalent dose) for at least 8 weeks with or without rectal 5-ASA.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Established diagnosis of ulcerative colitis (UC), based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
- •Active UC with disease confirmed by endoscopy findings and confirmed by central reader.
- •A modified Mayo Score 4-10, and with a centrally read endoscopy score activity of ≥ 2 points.
- •Mesalamine (5-ASA) refractory.
排除标准
- •Diagnosis of Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis,
- •Toxic megacolon or fulminant colitis,
- •Prior colon resection,
- •Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile infection) at screening,
- •Known celiac disease
- •Other inflammatory or bleeding disorders of the colon and intestine, or diseases what may cause diarrhea or gastrointestinal bleeding
- •History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack,
- •Subjects with known hypersensitivity to soy,
- •Treatment with methotrexate, azathioprine, 6-mercaptopurine TNF-alpha-antagonists, vedolizumab or certolizumab pegol, tacrolimus, or anti-integrin therapy within last 8 weeks prior to screening,
- •Treatment with any (topical or systemic) corticosteroid formulation for the treatment of IBD within last 7 days prior to endoscopy,
- •Treatment with other investigational drug within last 8 weeks prior to screening,
研究组 & 干预措施
LT-02
1.6 g PC in LT-02 BID
干预措施: LT-02 (Drug)
LT-02 Placebo
0 g PC in LT-02 Placebo BID
干预措施: LT-02 Placebo (Drug)
结局指标
主要结局
Rate of clinical remission
时间窗: 12 weeks
The percentage of subjects in clinical remission using the abbreviated modified Mayo score
次要结局
- Mucosal healing(12 weeks)
- Endoscopic response(12 weeks)
- Histological improvement(12 weeks)
- Quality of life(12 weeks)
- Clinical response(12 weeks)
- Endoscopic remission(12 weeks)