A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 239
- 试验地点
- 257
- 主要终点
- Percent of Participants Achieving Clinical Remission at Week 12
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Documented diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening, including ileal, colonic, or ileo-colonic disease distribution
- •Must have had an inadequate response, loss of response, or intolerance to 1 or more of the standard treatments
- •Must have active moderate to severe CD
- •Men and women must agree to follow specific methods of contraception, if applicable
排除标准
- •Severe or fulminant colitis that is likely to require surgery or hospitalization
- •Presence of a diagnosis of alternative forms of colitis (infectious, inflammatory including ulcerative colitis, malignant, toxic, indeterminate, etc.) other than Crohn's Disease
- •Previous exposure to BMS-986165 in any study
- •Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric, or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
BMS-986165 Dose 1
干预措施: BMS-986165 (Drug)
BMS-986165 Dose 2
干预措施: BMS-986165 (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Percent of Participants Achieving Clinical Remission at Week 12
时间窗: 12 weeks after first dose
Percent of participants achieving clinical remission at Week 12. Clinical remission is defined as achieving a Crohn's Disease Activity Index (CDAI) Score below 150. CDAI is a tool that helps doctors measure how severe someone's Crohn's disease is. It uses questions about symptoms experienced over a week to calculate a score. The scores range from 0 to 600 and are classified into different categories. Scores from 0 to 149 suggest the disease may be in remission. Scores from 150 to 220 indicate mild activity. Scores from 220 to 450 mean the disease is moderate to severe. Scores from 451 to 600 indicate severe disease. Higher scores mean more severe symptoms. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
Percent of Participants Achieving Endoscopic Response at Week 12
时间窗: 12 weeks after first dose
Endoscopic Response is defined as \>= 50% decrease from baseline in the Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD score is a way to measure how severe a person's bowel disease is. It looks at five different parts of the bowel and checks for things like ulcers and inflammation. Each part is given a score from 0 to 3 based on how bad the disease is. These scores are then added together for a total score ranging from 0 to 60. Higher scores indicate more severe disease. Baseline refers to the initial set of before data collected from participants before starting study treatment. Risk Difference and Odds Ratio prespecified to be collected for 3 mg and 6 mg BMS-986165 arms only.
次要结局
- Percent of Participants Achieving Clinical Response at Week 12(12 weeks after first dose)
- Percent of Participants Who Achieving Patient Reported Outcomes 2 (PRO2) Remission at Week 12(12 weeks after first dose)
- Change From Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12(12 weeks after first dose)