NCT05896124进行中（未招募）2 期
A Phase II Study to Evaluate Safety, Tolerability and Efficacy, of CS0159 in Patients Subjects With PBC (Primary Biliary Cholangitis), Multicenter, Randomized 12-week, Double-blind, Placebo-controlled, and 40-weeks Open Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 16
- 主要终点
- relative changes from baseline in ALP at week 12
研究概览
简要总结
A phase II study to evaluate safety, tolerability and efficacy of CS0159 in patients with PBC (Primary Biliary Cholangitis).
详细描述
This is a phase II study to evaluate safety, tolerability and efficacy of CS0159 in patients with PBC (Primary Biliary Cholangitis). The study has been designed to have two parts, the first part of the study will be double-blinded for 12 weeks. The second part of the study will be an open-label trail lasting 40 weeks.
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
- •When signing ICF age≥18 years≤75 years, male or female
- •Meets the diagnostic criteria of PBC, such as elevation ALP, positive AMA or AMA-M2, If negative for AMA, positive for PBC specific antibody and Liver biopsy meeting PBC criteria six months before screening
- •1.67 × ULN ≤ALP ≤ 10 × ULN and TBil≤ 3 × ULN
- •UDCA≥6 months before randomization and a stable dose (no less than 13-15 mg/kg/d in principle) ≥3 months after the efficacy was poor (meeting inclusion criteria 3), or UDCA was not tolerated, and stop taking UDCA (no UDCA use for ≥3 months before randomization)
- •Understand the study content, comply with the study protocol, and sign the ICF voluntarily
排除标准
- •ALT or AST>5×ULN；
- •OCA(Obercholic acid) in the 3 months prior to randomization
- •Known concomitant hepatobiliary disease or history
- •Significant hepatic impairment as defined by Child-Pugh classification of B or C, history of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥
- •Patients were screened for HBsAg positive, HCVAb positive, HIV Ab positive, or TPAb positive.
- •(creatinine, Cr) ≥1.5×ULN and Cr clearance rate <60 mL/min
- •Platelet<80×10^9/L；
- •ALB<3.5 g/dL
- •Severe pruritus or systemic medication was required within 2 months prior to randomization
- •Arrhythmia, Or during screening the QTc interval was ≥450 ms for male and 470 ms for female
- •History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the large intestine, eg, inflammatory bowel disease, prior or planned (during the study period) bariatric surgery (such as gastroplasty, roux-en-Y gastric bypass).
- •Concomitant use of medications, food, and drinks that are strong or moderate CYP3A4 inhibitors or inducers within 14 days prior to the first dose of study drug and throughout the study duration.
- •Diseases that may cause non-hepatic elevation of ALP (such as Paget's disease) or may result in a life expectancy of less than 2 years
- •A history of malignant tumor within 5 years prior to randomization
- •Perazathioprine, colchicine, cyclosporine, methotrexate, mycophenolate, and pentoxifylline were administered from 28 days before randomization to the entire clinical study period. Fenofibrate or other Bates; Budesonide and other systemic corticosteroid hormones; Hepatotoxic drugs; Liver protection Drugs and other hepatoprotective drugs were given a stable dose <28 days before randomization or could not be maintained during the trial; cholagogue
- •The administration of interleukin or other cytokine antibodies, as well as chemical factors or immunotherapy, was prohibited from 12 months prior to randomization throughout the clinical study period
- •Substance abuse or alcoholism from 6 months prior to randomization throughout the entire clinical study period
- •Poor blood pressure control is indicated by a systolic pressure greater than 160 mmHg or diastolic pressure greater than 100 mmHg during screening
- •Poor blood glucose control, that is, HBA1c >9.0% at screening
- •Pregnancy, planned pregnancy, lactation
- •Use of other investigational drugs within 3 months
- •Any other condition(s) that would compromise the safety of the patient or compromise the quality of the clinical study, as judged by the investigator
研究组 & 干预措施
2mg CS0159
Experimental
QD for 12 weeks
干预措施: 2mg CS0159 (Drug)
2mg CS0159
Experimental
QD for 12 weeks
干预措施: Placebo (Drug)
4mg CS0159
Experimental
QD for 12 weeks
干预措施: 2mg CS0159 (Drug)
Placebo
Experimental
QD for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
relative changes from baseline in ALP at week 12
时间窗: baseline to 12 weeks
Compared with placebo ,Percentage change of CS0159 to ALP relative to baseline
AE incidence
时间窗: baseline to 12 weeks
AE incidence in three arms
次要结局
- Absulute changes from baseline in ALP at week 12(baseline to 12 weeks)
- ALP and TBil(baseline to 12 weeks)
- Pruritus(from basline to 40 weeks)
- Liver function: ALT, AST, ALB, LDL-C, HDL-C, TBA, GGT, TC, TG(from baseline to week 40.)
研究者
研究点 (16)
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