CS0159 in Chinese Patients With PSC (Primary Sclerosing Cholangitis)

NCT05896137 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: PSC-CS0159-003
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (2)

• AE incidence

  AE incidence in placebo, 2mg and 4mg group

  Baseline to 12 weeks

• relative changes from baseline in ALP at week 12

  The reduction of percentage of ALP level from baseline to 12 weeks

  Baseline to 12 weeks

Secondary Outcomes (4)

• Absulute changes from baseline in ALP at week 12

  Baseline to 12 weeks

• 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

Study Arms (3)

2mg CS0159

EXPERIMENTAL

CS0159 tablet 2mg for 12 weeks

Drug: CS0159

4mg CS0159

EXPERIMENTAL

CS0159 tablet 4mg for 12 weeks

Drug: CS0159

Placebo

PLACEBO COMPARATOR

Placebo for 12 weeks

Drug: CS0159

Interventions

CS0159 DRUG

Oral QD

Also known as: Pleacbo

2mg CS0159; 4mg CS0159; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ×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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Cascade Pharmaceuticals, Inc: lead

Study Sites (11)

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, Anhui, China

Location

Beijing Friendship Hospital, Captail Medcial University

Beijing, Beijing Municipality, 100050, China

Location

Beijing YouAn Hostital, Captial Medical University

Beijing, Beijing Municipality, 100069, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Wuhan Union Hospital of China

Wuhan, Hubei, 430022, China

Location

The Seconed Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Location

Shaoyifu Hospital of Zhejiang University Medical

Hangzhou, Zhejiang, 310000, China

Location

The First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Rong Deng

  Cascade Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 9, 2023
• Study Start: August 7, 2023
• Primary Completion: November 14, 2025
• Study Completion: May 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)