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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in clinical remission rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
KRP203
Experimental
Edit
Experimental
干预措施: KRP203 (Drug)
Placebo
Placebo
干预措施: Placebo matching KRP203 (Drug)
结局指标
主要结局
Change in clinical remission rate
时间窗: 8 weeks
Difference between clinical remission rate of subjects on KRP203 versus placebo
次要结局
- Assessment of the pharmacodynamic effect of KRP203 on absolute lymphocyte count and leukocyte subsets in ulcerative colitis subjects(12 weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(8 weeks)
- Pharmacokinetic properties of KRP203 at steady-state using whole blood samples in patients with ulcerative colitis subjects(8 weeks)
- Difference in pharmacokinetic levels(12 weeks)
- Change in markers of inflammation(12 weeks)