CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)

NCT ID: NCT05896124

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-07
• Study Completion Date: 2025-07-31

Brief Summary

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

Detailed Description

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.

Conditions

Primary Biliary Cholangitis (PBC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2mg CS0159

QD for 12 weeks

Group Type: EXPERIMENTAL

2mg CS0159

Intervention Type: DRUG

Oral QD

Placebo

Intervention Type: DRUG

Oral QD

4mg CS0159

QD for 12 weeks

Group Type: EXPERIMENTAL

2mg CS0159

Intervention Type: DRUG

Oral QD

Placebo

QD for 12 weeks

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Oral QD

Interventions

2mg CS0159

Oral QD

Intervention Type: DRUG

Placebo

Oral QD

Intervention Type: DRUG

Eligibility 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≤ 3 × ULN

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

-

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. Patients were screened for HBsAg positive, HCVAb positive, HIV Ab positive, or TPAb positive.

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

7. Platelet<80×10^9/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. 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cascade Pharmaceuticals, Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rong Deng

Role: STUDY_DIRECTOR

Cascade Pharmaceuticals, Inc

Locations

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, Anhui, China

Beijing Friendship Hospital, Captail Medcial University

Beijing, Beijing Municipality, China

Beijing Youan Hostital, Captial Medical University

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangzhou, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Wuhan Union Hospital of China

Wuhan, Hubei, China

The Seconed Xiangya Hospital of Central South University

Changsha, Hunan, China

The Third People's Hospital of Zhenjiang

Zhenjiang, Jiangsu, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Shaoyifu Hospital of Zhejiang University Medical

Hangzhou, Zhejiang, China

The First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

PBC-CS0159-004

Identifier Type: -

Identifier Source: org_study_id