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Primary Biliary Cholangitis (PBC)Phase 2NCT05896124

CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)

A Phase 2 study testing 2mg CS0159 in people with Primary Biliary Cholangitis (PBC), run by Cascade Pharmaceuticals, Inc at 16 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 to evaluate safety, tolerability and efficacy of CS0159 in patients with PBC (Primary Biliary Cholangitis). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Biliary Cholangitis (PBC)
What is being tested?
2mg CS0159
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
16 sitesChina
Study dates
7 Aug 2023to 15 Mar 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

  • When signing ICF age≥18 years≤75 years, male or female
  • 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
  • 1.67 × ULN ≤ALP ≤ 10 × ULN and TBil≤ 3 × ULN
  • UDCA≥6 months before randomization and a stable dose (no less than 13-15 mg/kg/d in principle) ≥3 months after the efficacy was poor (meeting inclusion criteria 3), or UDCA was not tolerated, and stop taking UDCA (no UDCA use for ≥3 months before randomization)
  • Understand the study content, comply with the study protocol, and sign the ICF voluntarily
  • -

Who cannot join

  • ALT or AST>5×ULN；
  • OCA(Obercholic acid) in the 3 months prior to randomization
  • Known concomitant hepatobiliary disease or history
  • 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.
  • Patients were screened for HBsAg positive, HCVAb positive, HIV Ab positive, or TPAb positive.
  • (creatinine, Cr) ≥1.5×ULN and Cr clearance rate <60 mL/min
Show all 23Show fewer
  • Platelet<80×10^9/L；
  • INR>1.3
  • ALB<3.5 g/dL
  • Severe pruritus or systemic medication was required within 2 months prior to randomization
  • Arrhythmia, Or during screening the QTc interval was ≥450 ms for male and 470 ms for female
  • 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).
  • 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.
  • 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
  • A history of malignant tumor within 5 years prior to randomization
  • 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
  • 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
  • Substance abuse or alcoholism from 6 months prior to randomization throughout the entire clinical study period
  • Poor blood pressure control is indicated by a systolic pressure greater than 160 mmHg or diastolic pressure greater than 100 mmHg during screening
  • Poor blood glucose control, that is, HBA1c >9.0% at screening
  • Pregnancy, planned pregnancy, lactation
  • Use of other investigational drugs within 3 months
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Beijing Friendship Hospital, Capitai Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Youan Hospital, Capital 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

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • The Third Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510630

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangzhou

  • 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, 230001

  • 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

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

  • The Third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu

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 PBC (Primary Biliary Cholangitis), Multicenter, Randomized 12-week, Double-blind, Placebo-controlled, and 40-weeks Open Study

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

Read the 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.

Being tested
2mg CS0159, Placebo
Medical subject headings
Liver Cirrhosis, Biliary

What participants receive

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

  • 2mg CS0159Drug

    Oral QD

  • PlaceboDrug

    Oral QD

Study groups in NCT05896124
Study groupRoleWhat they receive
2mg CS0159ExperimentalQD for 12 weeks
Receives: Drug: 2mg CS0159; Drug: Placebo
4mg CS0159ExperimentalQD for 12 weeks
Receives: Drug: 2mg CS0159
PlaceboExperimentalQD for 12 weeks
Receives: Drug: Placebo

What is being measured

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

  1. AE incidence

    AE incidence in three arms

    Measured: baseline to 12 weeks

  2. relative changes from baseline in ALP at week 12

    Compared with placebo ,Percentage change of CS0159 to ALP relative to baseline

    Measured: baseline to 12 weeks

Secondary outcomes (4)

  1. Absulute changes from baseline in ALP at week 12

    Compared with placebo, CS0159 changes in serum ALP relative to baseline

    Measured: baseline to 12 weeks

  2. ALP and TBil

    Compared with placebo, the rate of subjects to achive the lelve of ALP< 1.67 ULN and (total bilirubin) TBil ≤ULN

    Measured: baseline to 12 weeks

  3. Pruritus

    the changes from baseline in Pruritus to week 40

    Measured: from basline to 40 weeks

  4. Liver function: ALT, AST, ALB, LDL-C, HDL-C, TBA, GGT, TC, TG

    The reduction of ALT, AST, ALB, LDL-C, HDL-C, TBA, GGT, TC, and TG from baseline to week 40.

    Measured: from baseline to week 40.

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 completion31 Dec 2025
  4. Study completion15 Mar 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
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05896124
Sponsor's protocol ID
PBC-CS0159-004
Status last verified
Mar 2026
First submitted
17 May 2023
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 2mg CS0159 in people with Primary Biliary Cholangitis (PBC), run by Cascade Pharmaceuticals, Inc at 16 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 6 inclusion and 23 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 16 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. 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 NCT05896124.

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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