NCT01951326已完成3 期
A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects With Moderately to Severely Active Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 103
- 主要终点
- Remission at Week 26
研究概览
简要总结
The investigators hypothesize that RHB-104 will have greater efficacy than placebo in Crohn's disease.
详细描述
A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn's Disease.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
RHB-104
Active Comparator
5 RHB-104 capsules administered orally BID
干预措施: RHB-104 (Drug)
Placebo
Placebo Comparator
5 placebo capsules administered orally BID
干预措施: Placebo (Drug)
结局指标
主要结局
Remission at Week 26
时间窗: Week 26
Reduction of the total Crohn's Disease Activity Index (CDAI) score to less than 150. Lower CDAI scores indicate a better outcome.
次要结局
- Response at Week 26(Week 26)
- Remission at Week 52(Week 52)
- Durable Remission Week 26 Through Week 52(Week 26 through week 52)
- Remission at Week 16(Week 16)
- Steroid Free Remission at Week 52(Week 52)
研究者
研究点 (103)
Loading locations...
相似试验
已完成
2 期
Induction of Clinical Response Using Rifaximin in Crohn's DiseaseCrohn's DiseaseNCT00603616Scott Lee36
撤回
2 期
Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's DiseaseCrohns DiseaseCrohn's DiseaseNCT04151225GlaxoSmithKline
已完成
1 期
Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending DoseInflammatory Bowel DiseaseNCT00868660Zealand Pharma66
已完成
2 期
Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent PericarditisPericarditisNCT04692766R-Pharm International, LLC20
已完成
3 期
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's DiseaseCrohn DiseaseNCT00207662Centocor, Inc.580