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

Phase 2TerminatedNCT04267393

Bristol-Myers Squibb124 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

124

Conditions

Nonalcoholic Steatohepatitis (NASH)

Interventions

BMS-986263DRUG

Specified dose on specified days

PlaceboOTHER

Specified dose on specified days

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (112)

Outcomes

Primary Outcomes

Percentage of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (NASH CRN Fibrosis Score), as Determined by Liver Biopsy After 12 Weeks of Treatment.

Percentage of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score), as determined by liver biopsy after 12 weeks of treatment. For the NASH CRN Fibrosis Score, fibrosis is staged on a 0 to 4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis). Responder is defined as achieved \>=1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score) as determined by liver biopsy from baseline to week 12/early treatment termination (ETT).

Time frame: 12 Weeks

Secondary Outcomes

Percentage of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (NASH CRN Fibrosis Score) With no Worsening of NASH After 12 Weeks of Treatment.

Percentage of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score) with no worsening of NASH after 12 weeks of treatment. For the NASH CRN Fibrosis Score, fibrosis is staged on a 0 to 4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Time frame: 12 Weeks

Percentage of Participants Who Achieve ≥ 2 Stage Improvement in Liver Fibrosis (NASH CRN Fibrosis Score) With no Worsening of NASH After 12 Weeks of Treatment.

Percentage of participants who achieve ≥ 2 stage improvement in liver fibrosis (NASH CRN Fibrosis Score) with no worsening of NASH after 12 weeks of treatment. For the NASH CRN Fibrosis Score, fibrosis is staged on a 0 to 4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis).

Time frame: 12 Weeks

Percentage of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (Modified Ishak Score) After 12 Weeks of Treatment.

Data from ClinicalTrials.gov

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Arizona Clinical Trials - Tucson

Chandler, Arizona, United States

Local Institution - 0173

Chandler, Arizona, United States

The Institute for Liver Health-The Institute for Liver Health

Chandler, Arizona, United States

Local Institution

Phoenix, Arizona, United States

Local Institution - 0140

La Jolla, California, United States

Local Institution - 0205

Lancaster, California, United States

GastroIntestinal BioSciences

Los Angeles, California, United States

Local Institution - 0143

Redwood City, California, United States

Florida Research Institute

Lakewood Rch, Florida, United States

Local Institution - 0024

Leesburg, Florida, United States

...and 102 more locations

Percentage of participants who achieve ≥ 1 stage improvement in liver fibrosis (modified Ishak score) after 12 weeks of treatment. A modified Ishak scoring system (0 to 6 scale) was originally developed to grade portal-based liver fibrosis associated with viral hepatitis. The modified Ishak system has been adapted to grade central-based liver fibrosis associated with NASH, and it also uses a 0 to 6 scale: 0: No fibrosis 1. perisinusoidal or periportal fibrosis 2. perisinusoidal and portal/periportal fibrosis 3. bridging fibrosis with linkage of \< 50% of vascular structures (portal and centrilobular) 4. bridging fibrosis with linkage of \> 50% of vascular structures (portal and centrilobular) 5. early or incomplete cirrhosis 6. established or advanced cirrhosis

Time frame: 12 Weeks

Percentage of Participants Who Achieve ≥ 2 Stage Improvement in Liver Fibrosis (Modified Ishak Score) After 12 Weeks of Treatment.

Percentage of participants who achieve ≥ 2 stage improvement in liver fibrosis (modified Ishak score) after 12 weeks of treatment. A modified Ishak scoring system (0 to 6 scale) was originally developed to grade portal-based liver fibrosis associated with viral hepatitis. The modified Ishak system has been adapted to grade central-based liver fibrosis associated with NASH, and it also uses a 0 to 6 scale: 0: No fibrosis 1. perisinusoidal or periportal fibrosis 2. perisinusoidal and portal/periportal fibrosis 3. bridging fibrosis with linkage of \< 50% of vascular structures (portal and centrilobular) 4. bridging fibrosis with linkage of \> 50% of vascular structures (portal and centrilobular) 5. early or incomplete cirrhosis 6. established or advanced cirrhosis

Time frame: 12 Weeks

Mean Change From Baseline in CPA After 12 Weeks of Treatment

Change from baseline in CPA after 12 weeks of treatment. Assessment of collagen proportionate area(CPA) is a method by which the amount (percentage) of collagen in stained tissue sections is analyzed using morphometric image analysis. This allows for a quantitative assessment of fibrosis. Percentage of fat in stained tissue sections is also analyzed using morphometric image analysis.

Time frame: 12 Weeks

Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Events (TESAE)

An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does have a causal relationship with this treatment.