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CS0159 in Chinese Patients With PSC (Primary Sclerosing Cholangitis)

Primary Purpose

Primary Sclerosing Cholangitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CS0159 2mg
Placebo
Sponsored by
Cascade Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 ALP≥1.67×ULN also≤10×ULN and TBil≤3 mg/dL 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, The subject was not hospitalized for IBD three months prior to screening, also, 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 Exclusion Criteria, 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 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 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 Hepatitis B surface antigen positive or Hepatitis C antibody positive during screening, (Human Immunodificidncy Virus Antibodies) HIVAb positive, or (Treponema PallidumAntibodies)TPAb was positive Cr(Creatinine)≥1.5×ULN also Cr(Creatinine)clearance rate<60 mL/min PLT(Platelet)<100×10^9/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 Used immunosuppressor Budesonide and other systemic glucocorticoids within 1 month prior to randomization and throughout the clinical study period Used Fenofibrate or whatever Tabates drug, Hepatotoxic, hepatic, protector, choleretic drug within 1 month prior to randomization and throughout the clinical study period 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

Sites / Locations

  • Beijing Friendship Hospital, Captail Medcial University
  • Beijing YouAn Hostital, Captial Medical University
  • Peking Union Medical College HospitalRecruiting
  • Peking Union Medical College HospitalRecruiting
  • Wuhan Union Hospital of China
  • The Seconed Xiangya Hospital of Central South University
  • Qilu Hospital of Shandong University
  • Renji Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
  • Shaoyifu Hospital of Zhejiang University MedicalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

2mg CS0159

4mg CS0159

Placebo

Arm Description

QD for 12 weeks

QD for 12 weeks

QD for 12 weeks

Outcomes

Primary Outcome Measures

AE incidence
AE incidence in placebo, 2mg and 4mg group
relative changes from baseline in ALP at week 12
The reduction of percentage of ALP level from baseline to 12 weeks

Secondary Outcome Measures

Absulute changes from baseline in ALP at week 12
The reduction of ALP level from baseline to 12 weeks
ALP and TBil changes
Compared with placebo, ALP< 1.67 ULN, (total bilirubin) TBil ≤ULN
TBA changes
BA change from baseline
Pruritus incidence
changes from baseline in the study period

Full Information

First Posted
May 18, 2023
Last Updated
August 31, 2023
Sponsor
Cascade Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05896137
Brief Title
CS0159 in Chinese Patients With PSC (Primary Sclerosing Cholangitis)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cascade Pharmaceuticals, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase II Study of CS0159 in Chinese patients with PSC(Primary Sclerosing Cholangitis)
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2mg CS0159
Arm Type
Experimental
Arm Description
QD for 12 weeks
Arm Title
4mg CS0159
Arm Type
Experimental
Arm Description
QD for 12 weeks
Arm Title
Placebo
Arm Type
Experimental
Arm Description
QD for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CS0159 2mg
Intervention Description
Oral QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral QD
Primary Outcome Measure Information:
Title
AE incidence
Description
AE incidence in placebo, 2mg and 4mg group
Time Frame
Baseline to 12 weeks
Title
relative changes from baseline in ALP at week 12
Description
The reduction of percentage of ALP level from baseline to 12 weeks
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Absulute changes from baseline in ALP at week 12
Description
The reduction of ALP level from baseline to 12 weeks
Time Frame
Baseline to 12 weeks
Title
ALP and TBil changes
Description
Compared with placebo, ALP< 1.67 ULN, (total bilirubin) TBil ≤ULN
Time Frame
Baseline to 12 weeks
Title
TBA changes
Description
BA change from baseline
Time Frame
from basline to 12 weeks, and to 40 weeks
Title
Pruritus incidence
Description
changes from baseline in the study period
Time Frame
from basline to 40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 ALP≥1.67×ULN also≤10×ULN and TBil≤3 mg/dL 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, The subject was not hospitalized for IBD three months prior to screening, also, 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 Exclusion Criteria, 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 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 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 Hepatitis B surface antigen positive or Hepatitis C antibody positive during screening, (Human Immunodificidncy Virus Antibodies) HIVAb positive, or (Treponema PallidumAntibodies)TPAb was positive Cr(Creatinine)≥1.5×ULN also Cr(Creatinine)clearance rate<60 mL/min PLT(Platelet)<100×10^9/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 Used immunosuppressor Budesonide and other systemic glucocorticoids within 1 month prior to randomization and throughout the clinical study period Used Fenofibrate or whatever Tabates drug, Hepatotoxic, hepatic, protector, choleretic drug within 1 month prior to randomization and throughout the clinical study period 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Deng
Phone
+86-021-68030121
Email
dengrong@cascadepharm.cm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Deng
Organizational Affiliation
Cascade Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Friendship Hospital, Captail Medcial University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
You Hong
Facility Name
Beijing YouAn Hostital, Captial Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Su Jun
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Ai Ming
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Wen
Facility Name
Wuhan Union Hospital of China
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Rong
Facility Name
The Seconed Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Min
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Kai
Facility Name
Renji Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Xiong
Phone
159 0098 4550
Facility Name
Shaoyifu Hospital of Zhejiang University Medical
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cao Qian

12. IPD Sharing Statement

Plan to Share IPD
No

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CS0159 in Chinese Patients With PSC (Primary Sclerosing Cholangitis)

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