Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis
A Phase 2, Randomized, Double-Blind, Parallel, Placebo-Controlled, Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of ASP3291 in Patients With Active Ulcerative Colitis
This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000 mg/d) or matching placebo in a 1:1 ratio for 8 weeks.
The study hypothesis is that treatment with ASP3291 compared to placebo will improve a patient's ulcerative colitis endoscopic score from baseline to Week 8.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Documented diagnosis of ulcerative colitis by endoscopy and histology consistent with diagnosis
- Must be able to provide informed consent
- Has a Modified Baron Score of at least 2 (as determined by the investigator) at 15 cm or more from the anal verge as assessed during the screening period
- Has an Ulcerative Colitis Clinical Score (UCCS) of at least 4, with a stool frequency and rectal bleeding score of at least 1 as assessed during the screening period
- If female, is at least 2 years postmenopausal, surgically sterile per documentation provided by a medical professional, agrees to sexual abstinence, or uses two approved highly effective methods of birth control during the study period and for 30 days after the last dose of study drug
- If male, agrees to sexual abstinence or to use two highly effective methods of birth control during the study period and for 90 days after last dose; agrees to not donate sperm during the study period and for 90 days after last dose
- Willing and able to comply with the study requirements
Exclusion Criteria:
- Has a history of any clinically significant neurological, renal, hepatic, gastrointestinal, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the investigator's opinion, would preclude participation in the study
Has severe Ulcerative Colitis as defined by an average bloody stool frequency of >6 per day and at least one of the following:
- Resting heart rate >90 bpm
- Oral temperature of >38°C (>100.4°F)
- Hemoglobin of <10.5 g/dL
- Has has undergone previous resective colonic surgery
- Has a significant or immediate risk for toxic megacolon
- Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history
- Has an extension of disease limited to ulcerative proctitis (i.e., disease extension less than 15 cm from the anal verge)
- Has an active peptic ulcer disease based on medical history
- Shows a stool culture positive for enteric pathogens during the screening period
- Had previous treatment with tumor necrosis factor-α (TNF α) inhibitors
- Had treatment with rectal corticosteroid within 2 weeks before Day -2
- Has active liver disease or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of normal (ULN) at screening
- Has an estimated glomerular filtration rate (using Cockroft-Gault formula corrected for body surface area) of <60 mL/min at screening
- Known history of human immunodeficiency virus antibody
- History of severe allergic or anaphylactic reactions requiring medical attention
- Has participated in another investigational study within 30 days before Visit 3
- History of drug or alcohol abuse in the past 2 years
- Has previously participated in a study with ASP3291
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:安慰剂
|
匹配的安慰剂药片
|
实验性的:ASP3291
|
Tablet, 1,000 mg (four 250-mg tablets), twice a day, 8 weeks
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Change from baseline (Visit 2) to Week 8 (Visit 7) in Modified Baron Score
大体时间:Baseline to Week 8
|
Baseline to Week 8
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Proportion of subjects with Modified Baron Score of 0 or 1 at Week 8 (Visit 7)
大体时间:Week 8
|
Week 8
|
Change in Ulcerative Colitis Clinical Score of >3
大体时间:Basline to Week 8
|
Basline to Week 8
|
Ulcerative Colitis Clinical Score stool frequency and rectal bleeding score of 0
大体时间:Week 8
|
Week 8
|
合作者和调查者
调查人员
- 研究主任:Robert Schinagl, Ph.D.、Drais Pharmaceuticals, Inc.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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