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)

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

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

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
. 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

Exclusion criteria

. Presence of documented secondary sclerosing cholangitis when screening,or direct evidence IgG4 related sclerosing cholangitis or serum IgG4 ≥ 4 ×ULN

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

AE incidence

Timeframe: Baseline to 12 weeks

relative changes from baseline in ALP at week 12

Timeframe: Baseline to 12 weeks

Trial details

NCT IDNCT05896137

SponsorCascade Pharmaceuticals, Inc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-14

View on ClinicalTrials.gov More Primary Sclerosing Cholangitis trials