CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

A phase II study to evaluate safety, tolerability and efficacy of CS0159 in patients with PBC (Primary Biliary Cholangitis).

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

Details

• Lead Sponsor: Cascade Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

1. When signing ICF age≥18 years≤75 years, male or female

2. 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

3. 1.67 × ULN≤ ALP≤ 10 × ULN and TBil ≤ 2 mg/dL

4. 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)

5. Understand the study content, comply with the study protocol, and sign the ICF voluntarily

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Exclusion Criteria:

1. ALT or AST>5×ULN；

2. OCA(Obercholic acid) in the 3 months prior to randomization

3. Known concomitant hepatobiliary disease or history

4. 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 ≥15.

5. Active Hepatitis B or C virus (HCV, HBV) infection

6. (creatinine, Cr）≥1.5×ULN and Cr clearance rate <60 mL/min

7. platelet<100×10^9/L；

8. INR>1.3

9. ALB<3.5 g/dL

10. Severe pruritus or systemic medication was required within 2 months prior to randomization

11. Arrhythmia, Or during screening the QTc interval was ≥450 ms for male and 470 ms for female

12. 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).

13. 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.

14. 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

15. A history of malignant tumor within 5 years prior to randomization

16. The following medications were administered one month prior to randomization and throughout the clinical study period: azathioprine, colchicine, cyclosporine A, methotrexate, mycophenolate mofetil, pentoxifylline, fenofibrate or other fibrates, budesonide and other systemic corticosteroids; hepatotoxic drugs; hepatic protectors; choleretic agents.

17. 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

18. Substance abuse or alcoholism from 6 months prior to randomization throughout the entire clinical study period

19. Poor blood pressure control is indicated by a systolic pressure greater than 160 mmHg or diastolic pressure greater than 100 mmHg during screening

20. Poor blood glucose control, that is, HBA1c >9.0% at screening

21. Pregnancy, planned pregnancy, lactation

22. Use of other investigational drugs within 3 months

23. 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