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Primary Sclerosing CholangitisPhase 2NCT05896137

CS0159 in Chinese Patients With PSC (Primary Sclerosing Cholangitis)

A Phase 2 study testing CS0159 in people with Primary Sclerosing Cholangitis, run by Cascade Pharmaceuticals, Inc at 11 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A phase II Study of CS0159 in Chinese patients with PSC(Primary Sclerosing Cholangitis) Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Sclerosing Cholangitis
What is being tested?
CS0159
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
11 sitesChina
Study dates
7 Aug 2023to May 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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
  • 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
  • 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
  • Immunosuppressants, budesonide, and other systemic glucocorticoids were used within 28 days before randomization and throughout the clinical study period;
  • Use of fenofibrate or another fibrate within 28 days prior to randomization and throughout the clinical study period; Hepatotoxic drugs; Hepatoprotective drugs and other hepatoprotective drugs were given stable doses <28 days before randomization or could not maintain stable doses during the trial; cholagogue
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Beijing Friendship Hospital, Captail Medcial University

    Beijing, Beijing Municipality, 100050

  • Beijing YouAn Hostital, Captial Medical University

    Beijing, Beijing Municipality, 100069

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

  • The Seconed Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • Shaoyifu Hospital of Zhejiang University Medical

    Hangzhou, Zhejiang, 310000

  • The First Affiliated Hospital,Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of USTC Anhui Provincial Hospital

    Hefei, Anhui

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200120

  • Wuhan Union Hospital of China

    Wuhan, Hubei, 430022

Other trials in China

About this study

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

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

Read the 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.

Being tested
CS0159
Medical subject headings
Cholangitis, Sclerosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CS0159Drug

    Also called Pleacbo

    Oral QD

Study groups in NCT05896137
Study groupRoleWhat they receive
2mg CS0159ExperimentalCS0159 tablet 2mg for 12 weeks
Receives: Drug: CS0159
4mg CS0159ExperimentalCS0159 tablet 4mg for 12 weeks
Receives: Drug: CS0159
PlaceboPlacebo comparatorPlacebo for 12 weeks
Receives: Drug: CS0159

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AE incidence

    AE incidence in placebo, 2mg and 4mg group

    Measured: Baseline to 12 weeks

  2. relative changes from baseline in ALP at week 12

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

    Measured: Baseline to 12 weeks

Secondary outcomes (4)

  1. Absulute changes from baseline in ALP at week 12

    The reduction of ALP level from baseline to 12 weeks

    Measured: Baseline to 12 weeks

  2. ALP and TBil changes

    Compared with placebo, ALP< 1.50 ULN, (total bilirubin) TBil ≤ULN

    Measured: Baseline to 12 weeks

  3. TBA changes

    BA change from baseline

    Measured: from basline to 12 weeks, and to 40 weeks

  4. Pruritus incidence

    changes from baseline in the study period

    Measured: from basline to 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start7 Aug 2023
  3. Primary completion14 Nov 2025
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05896137
Sponsor's protocol ID
PSC-CS0159-003
Status last verified
Mar 2026
First submitted
18 May 2023
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CS0159 in people with Primary Sclerosing Cholangitis, run by Cascade Pharmaceuticals, Inc at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AE incidence (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05896137.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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