Active — Not RecruitingPhase 2

CS0159 in Chinese Patients With PSC (Primary Sclerosing Cholangitis)

China50 participantsStarted 2023-08-07

Plain-language summary

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

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 1.50×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

✕. 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 concurrent comorbidities with other hepatobiliary diseases including, but not limited to: active hepatitis B virus or hepatitis C virus infection (see Exclusion Criterion 9), primary biliary cholangitis, complete biliary obstruction, acute cholecystitis or gallstones with significant symptoms, Autoimmune Hepatitis (AIH) or overlap with other autoimmune liver diseases, Alcoholic Hepatitis, Non-Alcoholic Steatohepatitis, Suspected or Diagnosed Primary Hepatocellular Cancer, and Bile Duct Cancer;
✕. 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

AE incidence

Timeframe: Baseline to 12 weeks

relative changes from baseline in ALP at week 12

Timeframe: Baseline to 12 weeks

NCT IDNCT05896137

SponsorCascade Pharmaceuticals, Inc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-14

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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
✓. 1.50×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

✕. 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 concurrent comorbidities with other hepatobiliary diseases including, but not limited to: active hepatitis B virus or hepatitis C virus infection (see Exclusion Criterion 9), primary biliary cholangitis, complete biliary obstruction, acute cholecystitis or gallstones with significant symptoms, Autoimmune Hepatitis (AIH) or overlap with other autoimmune liver diseases, Alcoholic Hepatitis, Non-Alcoholic Steatohepatitis, Suspected or Diagnosed Primary Hepatocellular Cancer, and Bile Duct Cancer;
✕. 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