A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 124
- 试验地点
- 102
- 主要终点
- Percentage of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (NASH CRN Fibrosis Score), as Determined by Liver Biopsy After 12 Weeks of Treatment.
研究概览
简要总结
The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 12 months
- •Men and women must agree to follow methods of contraception
排除标准
- •Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator
- •Known immunocompromised status or any disease or condition which might compromise participant safety
- •Prior exposure to BMS-986263
- •Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests
- •Hepatic decompensation
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Dose A BMS-986263
干预措施: BMS-986263 (Drug)
Dose B BMS-986263
干预措施: BMS-986263 (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (NASH CRN Fibrosis Score), as Determined by Liver Biopsy After 12 Weeks of Treatment.
时间窗: 12 Weeks
Percentage of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score), as determined by liver biopsy after 12 weeks of treatment. For the NASH CRN Fibrosis Score, fibrosis is staged on a 0 to 4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis). Responder is defined as achieved \>=1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score) as determined by liver biopsy from baseline to week 12/early treatment termination (ETT).
次要结局
- Percentage of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (NASH CRN Fibrosis Score) With no Worsening of NASH After 12 Weeks of Treatment.(12 Weeks)
- Percentage of Participants Who Achieve ≥ 2 Stage Improvement in Liver Fibrosis (NASH CRN Fibrosis Score) With no Worsening of NASH After 12 Weeks of Treatment.(12 Weeks)
- Percentage of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (Modified Ishak Score) After 12 Weeks of Treatment.(12 Weeks)
- Percentage of Participants Who Achieve ≥ 2 Stage Improvement in Liver Fibrosis (Modified Ishak Score) After 12 Weeks of Treatment.(12 Weeks)
- Mean Change From Baseline in CPA After 12 Weeks of Treatment(12 Weeks)
- Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Events (TESAE)(From First Treatment to end of Follow up (36 weeks))
- Number of Participants With Clinically Significant Changes in Clinical Laboratory Values.(From First Treatment to end of Follow up (36 weeks))
- Number of Participants With Clinically Significant Changes in Vitals Signs.(From First Treatment to end of Follow up (36 weeks))
- Number of Participants With Clinically Significant Changes in Physical Examination Findings.(From First Treatment to end of Follow up (36 weeks))
- Number of Participants With Clinically Significant Changes in Electrocardiogram Readings.(From First Treatment to end of Follow up (36 weeks))
- Number of Participants With Clinically Significant Changes in BMD.(From First Treatment to end of Follow up (36 weeks))
- Plasma Concentration of BMS-986263 Components at the End of 12 Weeks or ETT.(12 Weeks)