jRCT2080224801已完成2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis
Bristol-Myers Squibb1 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical Remission Response Rate at Week 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, parallel-group, treatment
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Active UC extending >= 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit
- •Documented diagnosis of UC of at least 3 months duration prior to screening
- •Active moderate to severe UC, defined by a modified Mayo score of 5 to 9 points, inclusive (modified Mayo score range = 0 to 9 points), which includes all of the following subscore values:
- •A stool frequency (SF) subscore of >= 2, and
- •A rectal bleeding (RB) subscore >= 1, and
- •An endoscopic (ES) subscore of >= 2 (screening endoscopy)
排除标准
- •Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile])
- •Stool positive for C. difficile toxin at screening visit
- •Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
结局指标
主要结局
Clinical Remission Response Rate at Week 12
时间窗: Week 12
Calculated using a modified Mayo score with the following: - Stool Frequency (SF) sub score <= 1, with >= 1 point decrease from baseline - Rectal Bleeding (RB) sub score = 0 - Endoscopic (ES) sub score <= 1 (modified, excludes friability)
次要结局
- Clinical Response Rate at 12 Weeks(12 Weeks)
- Endoscopic Response rate at Week 12(Week 12)
- Endoscopic Remission rate at Week 12(Week 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus (IM011-074)Systemic Lupus ErythematosusjRCT2080224856Bristol-Myers Squibb360
已完成
4 期
Long-Term Safety and Efficacy of BMS-986165 in Subjects with Psoriasis (IM011-075)jRCT2080224973Bristol-Myers Squibb60
终止
2 期
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus NephritisLupus NephritisNCT03943147Bristol-Myers Squibb16
招募中
不适用
A Phase 1/2 Study of BMS-986340 in Participants with Advanced Solid Tumors (CA052002)jRCT2031240229Bristol-Myers Squibb665
进行中（未招募）
1 期
Study of BMS-986179 Administered alone and in Combination with Nivolumab (BMS- 936558) in Subjects with Advanced Solid TumorsSolid tumorsMedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864EUCTR2016-000603-91-DEBristol-Myers Squibb International Corporation246