Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)

Study Overview
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Brief Summary
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The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).

Official Title
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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)

Conditions
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Nonalcoholic Steatohepatitis (NASH)

Intervention / Treatment
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* Drug: BMS-986263
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 12 months Men and women must agree to follow methods of contraception 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose A BMS-986263<br> | Drug: BMS-986263<br>* Specified dose on specified days<br>|
| Experimental: Dose B BMS-986263<br> | Drug: BMS-986263<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score) |  | At 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | At 12 weeks | 
| Proportion of participants with ≥ 2 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score) |  | At 12 weeks | 
| Proportion of participants with ≥ 1 stage improvement in modified Ishak liver fibrosis score |  | At 12 weeks | 
| Proportion of participants with ≥ 2 stage improvement in modified Ishak liver fibrosis score |  | At 12 weeks | 
| Change from baseline in collagen proportionate area (CPA) |  | At 12 weeks | 
| Incidence of Adverse Events (AEs) |  | Up to week 36 | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to week 36 | 
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests |  | Up to week 36 | 
| Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests |  | Up to week 36 | 
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests |  | Up to week 36 | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to week 36 | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to week 36 | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to week 36 | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to week 36 | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: Mean heart rate |  | Up to week 36 | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | PR interval: The time from the onset of the P wave to the start of the QRS complex | Up to week 36 | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval | QRS interval: A combination of the Q wave, R wave and S wave, the QRS complex represents ventricular depolarization | Up to week 36 | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | QT interval: Measured from the beginning of the QRS complex to the end of the T wave | Up to week 36 | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcB interval | QTcB interval: Corrected QT interval using Bazett's formula (QTcB) | Up to week 36 | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval | QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) | Up to week 36 | 
| Incidence of clinically significant changes in physical examination |  | Up to week 36 | 
| Change from baseline in bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DXA) scan |  | Up to week 36 | 
| Plasma concentrations of components of BMS-986263 for injection |  | Day 1 to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NASH, Nonalcoholic Steatohepatitis, Liver Disease, Compensated cirrhosis