RecruitingPhase 3NCT07282353

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

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)

Sponsor

Cascade Pharmaceuticals, Inc

Enrollment

135 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Primary Biliary Cholangitis

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 2mg CS0159 and a drug called Placebo for people with primary biliary cholangitis. The study is currently recruiting participants at 41 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG2mg CS0159

Oral QD

DRUGPlacebo

Oral QD

Locations(42)

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Youan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Mengchao Hepatobiliary Hospital Of Fujian Medical University

Fuzhou, Fujian, China

Xiamen Hospital of T.C,M.

Xiamen, Fujian, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

The Fourth Hospital Of Harbin Medical University

Harbin, Heilongjiang, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Taihe Hospital of Shiyan

Shiyan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

The Fifth People's Hospital of Suzhou

Suzhou, Jiangsu, China

The Fifth People's Hospital Of Wuxi

Wuxi, Jiangsu, China

The Third People's Hospital of Zhenjiang

Zhenjiang, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The Fourth People's Hospital of Qinghai Province

Xining, Qinghai, China

Baoji People's Hospital

Baoji, Shaanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Linyi People's Hospital

Linyi, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Shanghai Jiao Tong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, China

Xin Hua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

Hangzhou Xixi Hospital

Hangzhou, Zhejiang, China

Ningbo Medical Center Li Huili hospital

Ningbo, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

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NCT07282353

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