NCT05896137进行中（未招募）2 期
A Phase II Study to Evaluate Safety, Tolerability and Efficacy, of CS0159 in Patients Subjects With Primary Sclerosing Cholangitis, Multicenter, Randomized, 12-week Double-blind, Placebo-controlled, and 40-week 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
- 50
- 试验地点
- 11
- 主要终点
- AE incidence
研究概览
简要总结
A phase II Study of CS0159 in Chinese patients with PSC(Primary Sclerosing Cholangitis)
详细描述
A phase II study to evaluate safety, tolerability and efficacy, of CS0159 in patients with Primary Sclerosing Cholangitis, this is a multicenter, randomized, 12-weeks double-blind, placebo-controlled, and 40-week open study.
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
- •Male or female age≥18 or age≤75 years when sign ICF
- •Within the last year, have a clinical diagnosis of PSC with a consistent magnetic resonance cholangiopancreatography (MRCP) orendoscopic retrograde cholangiopancreatography (ERCP) Prcutaneous Transhepatic Cholangiography(PTC) showing sclerosing cholangitis
- •1.50×ULN≤ALP≤10×ULN, and TBil≤3×ULN during screen
- •Taken UDCA(≤25mg/kg/d)≥6 months before randomization and stable does≥ 3 months, or not used UDCA≥3 months before randomization
- •For subject with a history of IBD
- •Patients with Crohn's Disease (CD),Must be in remission, CDAI<150 or CDAI of score ≤4
- •Patients with(Ulcerative Colitis)UC,Must be in remission or only mild activity,Some Mayo scores range from 0 to 4
- •Be able to understand and Comply with the study protocol sign a written informed consent form(ICF)voluntarily
排除标准
- •Presence of documented secondary sclerosing cholangitis when screening,or direct evidence IgG4 related sclerosing cholangitis or serum IgG4 ≥ 4 ×ULN
- •Small duct PSC
- •ALT or AST>5×ULN
- •Taken( ObeticholicAcid) OCA within 3 months before randomization
- •Acute cholangitis was suspected or confirmed within 3 months prior to randomization, Including acute cholangitis being treated during screening
- •Presence of percutaneous drain or bile duct stent at the time of screening or during the study
- •Known concurrent comorbidities with other hepatobiliary diseases including, but not limited to: active hepatitis B virus or hepatitis C virus infection (see Exclusion Criterion 9), primary biliary cholangitis, complete biliary obstruction, acute cholecystitis or gallstones with significant symptoms, Autoimmune Hepatitis (AIH) or overlap with other autoimmune liver diseases, Alcoholic Hepatitis, Non-Alcoholic Steatohepatitis, Suspected or Diagnosed Primary Hepatocellular Cancer, and Bile Duct Cancer;
- •Child-Pugh patients with grade B or C cirrhosis,Present complications related to cirrhosis or End-stage liver disease ,Including history of liver transplantation Preparing for liver transplantation (Model for End-Stage Liver Disease)MELD≥15，Portal hypertension complications,Complications of cirrhosis
- •Patients who are HBsAg-positive, HCVAb-positive, HIVAb-positive or TPAb-positive at screening
- •Cr(Creatinine)≥1.5×ULN also Cr(Creatinine)clearance rate<60 mL/min
- •PLT(Platelet)<80×10^9/L
- •INR(international normalized ratio)>1.3
- •ALB<3.5g/dL
- •Severe pruritus may require systemic medication Within 2 months prior to randomization
- •Arrhythmia,male QTc≥450 ms,female QTc≥470 ms, during screening
- •A disease that interferes with the absorption, distribution, metabolism, or excretion of a test drug,such as moderate to severe activity IBD patient, Previous gastric bypass surgery
- •Moderate or intense inhibition of CYP3A4 was performed during 14 days prior to randomization and throughout the trial Preparation or inducer
- •The presence of diseases that may cause non-hepatic elevation of ALP (e.g. Paget's disease) or may cause it Diseases with a life expectancy of less than 2 years
- •History of malignancy within the past 5 years prior to randomization
- •Immunosuppressants, budesonide, and other systemic glucocorticoids were used within 28 days before randomization and throughout the clinical study period;
- •Use of fenofibrate or another fibrate within 28 days prior to randomization and throughout the clinical study period; Hepatotoxic drugs; Hepatoprotective drugs and other hepatoprotective drugs were given stable doses <28 days before randomization or could not maintain stable doses during the trial; cholagogue
- •Interleukin or other cytokines were used 12 months before randomization and throughout the trial Or antibodies to chemokines or immunotherapy
- •Drug and/or alcohol abuse within the first six months of randomization
- •Poor blood pressure control,systolic pressure>160 mmHg or dpb >100 mmHg
- •Poor blood sugar control,Glycated hemoglobin>9.0%
- •Females who are pregnant or plan to pregnant,Fertile but refusing to sign informed consent, or breastfeed
- •Participated any other study within 30 days prior randomization,and received other experimental medications therapy
- •It is unsuitable to participate for the study or has other diseases by the investigator
研究组 & 干预措施
2mg CS0159
Experimental
CS0159 tablet 2mg for 12 weeks
干预措施: CS0159 (Drug)
4mg CS0159
Experimental
CS0159 tablet 4mg for 12 weeks
干预措施: CS0159 (Drug)
Placebo
Placebo Comparator
Placebo for 12 weeks
干预措施: CS0159 (Drug)
结局指标
主要结局
AE incidence
时间窗: Baseline to 12 weeks
AE incidence in placebo, 2mg and 4mg group
relative changes from baseline in ALP at week 12
时间窗: Baseline to 12 weeks
The reduction of percentage of ALP level from baseline to 12 weeks
次要结局
- ALP and TBil changes(Baseline to 12 weeks)
- TBA changes(from basline to 12 weeks, and to 40 weeks)
- Pruritus incidence(from basline to 40 weeks)
- Absulute changes from baseline in ALP at week 12(Baseline to 12 weeks)
研究者
研究点 (11)
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