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Clinical Trials List

Protocol NumberIM025-017

NCT Number(ClinicalTrials.gov Identfier)NCT04267393

2020-08-20 - 2023-12-31

Phase II

Recruiting4

ICD-10K74.4

Secondary biliary cirrhosis

ICD-10K75.81

Nonalcoholic steatohepatitis (NASH)

ICD-10K76.0

Fatty (change of) liver, not elsewhere classified

ICD-10K76.89

Other specified diseases of liver

ICD-10R16.2

Hepatomegaly with splenomegaly, not elsewhere classified

ICD-9571.8

Other chronic nonalcoholic liver disease

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)

Trial Applicant

BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
Sponsor

Bristol-Myers Squibb
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Chi-Jen Chu 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Rong-Nan Chien 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jia-Horng Kao Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

蘇東弘 Digestive System Department
Shih-Jer Hsu Digestive System Department
Chen-Hua Liu Digestive System Department
楊宏志 Digestive System Department
Chun-Jen Liu Digestive System Department
曾岱宗 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jee-Fu Huang 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)

Objectives

Randomized study to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH) • To evaluate the efficacy of BMS-986263 compared with placebo to improve liver fibrosis in participants with compensated cirrhosis due to NASH • To further assess the efficacy of BMS-986263 compared with placebo to improve liver fibrosis, as determined by liver biopsy, in participants with compensated cirrhosis due to NASH • To assess the safety and tolerability of BMS-986263 in participants with compensated cirrhosis due to NASH • To assess the PK of BMS-986263 in participants with compensated cirrhosis due to NASH

Test Drug

BMS-986263

Active Ingredient

HSP47 siRNA

Dosage Form

Injection

Dosage

10 mg/vial

Endpoints

Primary Outcome Measures :
Proportion of participants who achieve ≥ 1 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score) [ Time Frame: At 12 weeks ]

Secondary Outcome Measures :
Proportion of participants with ≥ 1 stage improvement in liver fibrosis with no increase of the NAS [NAFLD (Nonalcoholic fatty liver disease) Activity Score] by ≥ 1 point [ Time Frame: At 12 weeks ]
Proportion of participants with ≥ 2 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score) [ Time Frame: At 12 weeks ]
Proportion of participants with ≥ 1 stage improvement in modified Ishak liver fibrosis score [ Time Frame: At 12 weeks ]
Proportion of participants with ≥ 2 stage improvement in modified Ishak liver fibrosis score [ Time Frame: At 12 weeks ]
Change from baseline in collagen proportionate area (CPA) [ Time Frame: At 12 weeks ]
Incidence of participants with adverse events (AEs) [ Time Frame: Up to week 36 ]
Incidence of participants with serious adverse events (SAEs) [ Time Frame: Up to week 36 ]
Incidence of participants with change in clinical laboratory tests of blood [ Time Frame: Up to week 36 ]
Incidence of participants with change in clinical laboratory tests of blood serum [ Time Frame: Up to week 36 ]
Incidence of participants with change in clinical laboratory tests of urine [ Time Frame: Up to week 36 ]
Incidence of participants with change in vital sign of weight [ Time Frame: Up to week 36 ]
Incidence of participants with change in vital sign of body temperature [ Time Frame: Up to week 36 ]
Incidence of participants with change in vital sign of respiratory rate [ Time Frame: Up to week 36 ]
Incidence of participants with change in vital sign of blood pressure [ Time Frame: Up to week 36 ]
Incidence of participants with change in vital sign of heart rate [ Time Frame: Up to week 36 ]
Incidence of participants with change in electrocardiogram (ECG) [ Time Frame: Up to week 36 ]
Incidence of participants with change in physical examination [ Time Frame: Up to week 36 ]
Change from baseline in bone mineral density measured by DXA (dual-energy x-ray absorptiometry) [ Time Frame: At week 36 ]
Plasma concentrations of BMS-986263 [ Time Frame: Day 1 to week 12 ]
Plasma concentrations of DPD (di-retinamide-PEG-di-retinamide) [ Time Frame: Day 1 to week 12 ]
Plasma concentrations of S104 (lipid component) [ Time Frame: Day 1 to week 12 ]

Inclution Criteria

Inclusion Criteria:

Participants with liver biopsy fibrosis score stage 4 performed within 6 months
Men and women must agree to follow methods of contraception

Exclusion Criteria

Exclusion Criteria:

Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator
Known immunocompromised status or any disease or condition which might compromise participant safety
Prior exposure to BMS-986263
Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests
Hepatic decompensation
Other protocol-defined inclusion/exclusion criteria apply

The Estimated Number of Participants

Taiwan

7 participants
Global

1250 participants