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A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA

NCT07282353 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-12-30

No results posted yet for this study

Summary

A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients with Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (UDCA).

Conditions

Interventions

DRUG

2mg CS0159

Oral QD

DRUG

Placebo

Oral QD

Sponsors & Collaborators

  • Cascade Pharmaceuticals, Inc

    lead OTHER

Principal Investigators

  • Ma Xiong, MD · Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-12-09
Completion
2028-01-06

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07282353 on ClinicalTrials.gov