CS0159 in Chinese Patients With PSC (Primary Sclerosing Cholangitis)

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase II Study of CS0159 in Chinese patients with PSC(Primary Sclerosing Cholangitis)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cascade Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

1. Male or female age≥18 or age≤75 years when sign ICF

2. 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

3. ALP≥1.67×ULN also≤10×ULN and TBil≤3 mg/dL during screen

4. Taken UDCA(≤25mg/kg/d)≥6 months before randomization and stable does≥ 3 months, or not used UDCA≥3 months before randomization

5. For subject with a history of IBD, The subject was not hospitalized for IBD three months prior to screening, also,

1. Patients with Crohn's Disease (CD),Must be in remission, CDAI<150 or CDAI of score ≤4

2. Patients with(Ulcerative Colitis)UC,Must be in remission or only mild activity,Some Mayo scores range from 0 to 4

6. Be able to understand and Comply with the study protocol sign a written informed consent form(ICF)voluntarily

Exclusion Criteria,

1. Presence of documented secondary sclerosing cholangitis when screening,or direct evidence IgG4 related sclerosing cholangitis or serum IgG4 ≥ 4 ×ULN

2. Small duct PSC

3. ALT or AST>5×ULN

4. Taken( ObeticholicAcid) OCA within 3 months before randomization

5. Acute cholangitis was suspected or confirmed within 3 months prior to randomization, Including acute cholangitis being treated during screening

6. Presence of percutaneous drain or bile duct stent at the time of screening or during the study

7. Known within the other hepatobiliary diseases or medical history,including but not limited to: Active hepatitis B Virus or hepatitis C virus infection, PBC, Complete biliary obstruction, acute cholecystitis orgall-stone,Autoimmune hepatitis or overlap with other autoimmune liver diseases, Alcoholic Hepatitis, NASH, Suspected or confirmed primary liver cancer,cholangiocarcinoma

8. 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

9. Hepatitis B surface antigen positive or Hepatitis C antibody positive during screening, (Human Immunodificidncy Virus Antibodies) HIVAb positive, or (Treponema PallidumAntibodies)TPAb was positive

10. Cr(Creatinine)≥1.5×ULN also Cr(Creatinine)clearance rate<60 mL/min

11. PLT(Platelet)<100×10^9/L

12. INR(international normalized ratio)>1.3

13. ALB<3.5g/dL

14. Severe pruritus may require systemic medication Within 2 months prior to randomization

15. Arrhythmia,male QTc≥450 ms,female QTc≥470 ms, during screening

16. 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

17. Moderate or intense inhibition of CYP3A4 was performed during 14 days prior to randomization and throughout the trial Preparation or inducer

18. 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

19. History of malignancy within the past 5 years prior to randomization

20. Used immunosuppressor Budesonide and other systemic glucocorticoids within 1 month prior to randomization and throughout the clinical study period

21. Used Fenofibrate or whatever Tabates drug, Hepatotoxic, hepatic, protector, choleretic drug within 1 month prior to randomization and throughout the clinical study period

22. Interleukin or other cytokines were used 12 months before randomization and throughout the trial Or antibodies to chemokines or immunotherapy

23. Drug and/or alcohol abuse within the first six months of randomization

24. Poor blood pressure control,systolic pressure>160 mmHg or dpb >100 mmHg

25. Poor blood sugar control,Glycated hemoglobin>9.0%

26. Females who are pregnant or plan to pregnant,Fertile but refusing to sign informed consent, or breastfeed

27. Participated any other study within 30 days prior randomization,and received other experimental medications therapy

28. It is unsuitable to participate for the study or has other diseases by the investigator