Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients
A Multi-centre, Double-blind, Placebo Controlled, Parallel Group, Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of KRP203 in Subjects With Moderately Active Refractory Ulcerative Colitis
This study is designed as a proof of concept of KRP203 for induction of remission in ulcerative colitis (UC). The purpose of this study is to evaluate clinical benefit of KRP203 in subjects with moderately active refractory ulcerative colitis.
The study will provide safety and tolerability data in this subject population up to eight weeks of treatment with KRP203. Additionally, this study will evaluate the duration of a clinical response to KRP203 by following up responding subjects for an additional 12 weeks.
研究概览
详细说明
This is a multi-centre, double-blind, placebo controlled, parallel group, proof of concept study to evaluate the efficacy, safety and tolerability of KRP203 in subjects with moderately active refractory ulcerative colitis subjects. In total, approximately 72 subjects will be randomized into the study.
After 30 patients have completed the 8 week treatment period with KRP203 or placebo, there will be an interim analysis to determine preliminary efficacy. The study will consist of up to 28 day screening period (day -35 to -8), baseline period (day -7 to day -1), treatment period (day 1 to day 56), follow-up period and study completion.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
-
Budapest、匈牙利、1083
- Novartis Investigative Site
-
Debrecen、匈牙利、4032
- Novartis Investigative Site
-
-
-
-
-
Frankfurt am Main、德国、60318
- Novartis Investigative Site
-
Hamburg、德国、20148
- Novartis Investigative Site
-
Köln、德国、51103
- Novartis Investigative Site
-
-
-
-
-
Gent、比利时、9000
- Novartis Investigative Site
-
Leuven、比利时、3000
- Novartis Investigative Site
-
-
-
-
-
Stockholm、瑞典、116 91
- Novartis Investigative Site
-
Stockholm、瑞典、SE-141 86
- Novartis Investigative Site
-
Uppsala、瑞典、751 85
- Novartis Investigative Site
-
-
-
-
-
Bern、瑞士、3010
- Novartis Investigative Site
-
Zurich、瑞士、8091
- Novartis Investigative Site
-
-
-
-
-
Nottingham、英国、NG7 2UH
- Novartis Investigative Site
-
-
Oxfordshire
-
Oxford、Oxfordshire、英国、OX3 9DU
- Novartis Investigative Site
-
-
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:
- Active disease defined by partial Mayo score and modified Baron score with disease extending at least 25 cm from the anal verge
- Subjects must have inadequately responded or intolerance to 5-ASA therapy
Exclusion Criteria:
- Subjects receiving treatment for UC (other than 5-ASAs and steroids) within the time frame mentioned in protocol
- Past or recent history of significant medical illness and/or clinically significant lab abnormalities including but not limited to hematology, clinical chemistry, urine analysis, ECG abnormalities, HIV, Hepatitis B/C
- Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, ophthalmic, cardiac, blood, renal, hepatic, infectious, psychiatric or any medically unstable condition, as assessed by the primary treating physician which, in the opinion of the investigator, would immunocompromise the subject and/or place the subject at unacceptable risk for participation in a study of an immunomodulatory therapy Other protocol-defined inclusion/exclusion criteria apply
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
|
|
实验性的：KRP203
Experimental Edit Experimental |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in clinical remission rate
大体时间：8 weeks
|
Difference between clinical remission rate of subjects on KRP203 versus placebo
|
8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
大体时间：8 weeks
|
Safety and tolerability of KRP203 assessed by the number of subjects with adverse events where KRP203 is given as an oral drug for 8 weeks once a day in ulcerative colitis subjects
|
8 weeks
|
|
Pharmacokinetic properties of KRP203 at steady-state using whole blood samples in patients with ulcerative colitis subjects
大体时间：8 weeks
|
8 weeks
|
|
|
Difference in pharmacokinetic levels
大体时间：12 weeks
|
To explore the relationship between KRP203 and KRP203-P pharmacokinetic levels and clinical efficacy outcomes such as the partial Mayo score and endoscopic modified Baron Score
|
12 weeks
|
|
Assessment of the pharmacodynamic effect of KRP203 on absolute lymphocyte count and leukocyte subsets in ulcerative colitis subjects
大体时间：12 weeks
|
12 weeks
|
|
|
Change in markers of inflammation
大体时间：12 weeks
|
Measure of the effect of KRP203 on markers of inflammation, including but not limited to ESR, CRP and fecal calprotectin/ lactoferrin as well as histopathological markers of gut mucosa using biopsy samples in ulcerative colitis subjects
|
12 weeks
|
合作者和调查者
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.