Clinical trial NCT04267393: Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis (NASH)
Keywords: Nonalcoholic Steatohepatitis
Liver Disease
NASH
Compensated cirrhosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-02-12
Enrollment: 124
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 Weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 Weeks
measure: 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.
timeFrame: 12 Weeks
measure: Percentage of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (Modified Ishak Score) After 12 Weeks of Treatment.
timeFrame: 12 Weeks
measure: Percentage of Participants Who Achieve ≥ 2 Stage Improvement in Liver Fibrosis (Modified Ishak Score) After 12 Weeks of Treatment.
timeFrame: 12 Weeks
measure: Mean Change From Baseline in CPA After 12 Weeks of Treatment
timeFrame: 12 Weeks
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Events (TESAE)
timeFrame: From First Treatment to end of Follow up (36 weeks)
measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values.
timeFrame: From First Treatment to end of Follow up (36 weeks)
measure: Number of Participants With Clinically Significant Changes in Vitals Signs.
timeFrame: From First Treatment to end of Follow up (36 weeks)
measure: Number of Participants With Clinically Significant Changes in Physical Examination Findings.
timeFrame: From First Treatment to end of Follow up (36 weeks)
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram Readings.
timeFrame: From First Treatment to end of Follow up (36 weeks)
measure: Number of Participants With Clinically Significant Changes in BMD.
timeFrame: From First Treatment to end of Follow up (36 weeks)
measure: Plasma Concentration of BMS-986263 Components at the End of 12 Weeks or ETT.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Clinical Trials - Tucson
state: Arizona
city: Chandler
country: United States
facility: Local Institution - 0173
state: Arizona
city: Chandler
country: United States
facility: The Institute for Liver Health-The Institute for Liver Health
state: Arizona
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: La Jolla
country: United States
facility: Local Institution - 0140
state: California
city: Lancaster
country: United States
facility: Local Institution - 0205
state: California
city: Los Angeles
country: United States
facility: GastroIntestinal BioSciences
state: California
city: Redwood City
country: United States
facility: Local Institution - 0143
state: California
city: Lakewood Ranch
country: United States
facility: Florida Research Institute
state: Florida
city: Leesburg
country: United States
facility: Local Institution - 0024
state: Florida
city: Miami
country: United States
facility: Local Institution - 0061
state: Florida
city: Winter Park
country: United States
facility: Local Institution - 0025
state: Florida
city: Iowa City
country: United States
facility: Local Institution - 0121
state: Iowa
city: Baltimore
country: United States
facility: Local Institution - 0150
state: Maryland
city: Fall River
country: United States
facility: Local Institution
state: Massachusetts
city: Kansas City
country: United States
facility: Local Institution - 0077
state: Missouri
city: Omaha
country: United States
facility: Local Institution - 0186
state: Nebraska
city: Buffalo
country: United States
facility: Research Foundation of SUNY - University of Buffalo
state: New York
city: New York
country: United States
facility: NYU Langone Health-Department of Medicine
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Morehead City
country: United States
facility: Local Institution - 0206
state: North Carolina
city: Philadelphia
country: United States
facility: Local Institution - 0177
state: Pennsylvania
city: Philadelphia
country: United States
facility: Local Institution - 0017
state: Pennsylvania
city: Chattanooga
country: United States
facility: University Diabetes & Endocrine Consultants
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 0171
state: Texas
city: Houston
country: United States
facility: Local Institution - 0109
state: Texas
city: McAllen
country: United States
facility: Local Institution
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0013
state: Texas
city: Richmond
country: United States
facility: Local Institution - 0122
state: Virginia
city: Ciudad de Buenos Aires
country: Argentina
facility: Local Institution - 0089
state: Buenos Aires
city: Florencio Varela
country: Argentina
facility: Local Institution - 0126
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Local Institution - 0209
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 0059
city: Edegem
country: Belgium
facility: Local Institution - 0009
city: Gent
country: Belgium
facility: Local Institution - 0006
city: Leuven
country: Belgium
facility: Local Institution - 0133
city: Salvador
country: Brazil
facility: Local Institution - 0083
state: Bahia
city: Bento Goncalves
country: Brazil
facility: Local Institution - 0182
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Barretos
country: Brazil
facility: Local Institution - 0187
state: SAO Paulo
city: Botucatu
country: Brazil
facility: Local Institution - 0188
state: SAO Paulo
city: Ribeirão Preto
country: Brazil
facility: Local Institution
state: SAO Paulo
city: Sao Bernardo do Campo
country: Brazil
facility: Local Institution - 0196
state: SAO Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution - 0120
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Victoria
country: Canada
facility: Local Institution - 0128
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution - 0097
state: Ontario
city: Lyon
country: France
facility: Local Institution - 0094
city: Nice
country: France
facility: Local Institution - 0031
city: Paris
country: France
facility: Local Institution - 0101
city: Paris
country: France
facility: Local Institution - 0105
city: Strasbourg
country: France
facility: Local Institution - 0137
city: Vandoeuvre les Nancy
country: France
facility: Local Institution - 0029
city: Créteil
country: France
facility: Local Institution - 0202
state: Île-de-France
city: Frankfurt
country: Germany
facility: Local Institution - 0082
state: Hessen
city: Berlin
country: Germany
facility: Local Institution - 0091
city: Essen
country: Germany
facility: Local Institution - 0099
city: Hannover
country: Germany
facility: Local Institution - 0096
city: Kiel
country: Germany
facility: Local Institution - 0073
city: Lübeck
country: Germany
facility: Local Institution - 0194
city: Mainz
country: Germany
facility: Local Institution - 0071
city: Munich
country: Germany
facility: Local Institution - 0060
city: Trier
country: Germany
facility: Local Institution - 0204
city: Haifa
country: Israel
facility: Local Institution - 0056
city: Petah Tikva
country: Israel
facility: Local Institution - 0076
city: Ramat Gan
country: Israel
facility: Local Institution - 0058
city: Tel Aviv
country: Israel
facility: Local Institution - 0057
city: Bologna
country: Italy
facility: Local Institution - 0054
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Di Messina G. Martino-D.A.I. Medicina Interna
city: Palermo
country: Italy
facility: Local Institution - 0115
city: Pisa
country: Italy
facility: Local Institution - 0051
city: Rome
country: Italy
facility: Local Institution
city: Toon
country: Japan
facility: Local Institution - 0200
state: Ehime
city: Kurume
country: Japan
facility: Local Institution - 0048
state: Fukuoka
city: Sapporo
country: Japan
facility: Local Institution - 0049
state: Hokkaido
city: Shiwagun Yahabatyo
country: Japan
facility: Local Institution - 0127
state: Iwate
city: Yokohama
country: Japan
facility: Local Institution - 0075
state: Kanagawa
city: Matsumoto
country: Japan
facility: Local Institution - 0155
state: Nagano
city: Kashihara
country: Japan
facility: Local Institution - 0111
state: Nara
city: Sakai
country: Japan
facility: Local Institution - 0163
state: Osaka
city: Bunkyō
country: Japan
facility: Local Institution - 0125
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution - 0138
state: Tokyo
city: Aomori
country: Japan
facility: Local Institution - 0199
city: Gifu
country: Japan
facility: Local Institution - 0193
city: Hiroshima
country: Japan
facility: Local Institution - 0026
city: Kagoshima
country: Japan
facility: Local Institution - 0135
city: Kyoto
country: Japan
facility: Local Institution - 0131
city: Yamagata
country: Japan
facility: Local Institution - 0132
city: Incheon
country: Korea, Republic of
facility: Local Institution - 0093
state: Incheon-gwangyeoksi [Incheon]
city: Seodaemun-gu
country: Korea, Republic of
facility: Local Institution - 0066
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0090
city: San Juan
country: Puerto Rico
facility: Local Institution - 0012
city: Barcelona
country: Spain
facility: Local Institution - 0040
city: Madrid
country: Spain
facility: Local Institution - 0080
city: Madrid
country: Spain
facility: Local Institution - 0039
city: Madrid
country: Spain
facility: Local Institution - 0038
city: Malaga
country: Spain
facility: Local Institution - 0036
city: Santander
country: Spain
facility: Local Institution - 0037
city: Sevilla
country: Spain
facility: Local Institution - 0041
city: Valencia
country: Spain
facility: Local Institution - 0035
city: València
country: Spain
facility: Local Institution - 0043
city: Lugano
country: Switzerland
facility: Local Institution - 0102
state: Ticino
city: Berne
country: Switzerland
facility: Local Institution - 0074
city: Kaohsiung
country: Taiwan
facility: Local Institution - 0001
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taoyuan
country: Taiwan
facility: Local Institution - 0004
city: Nottingham
country: United Kingdom
facility: Local Institution - 0011
state: Nottinghamshire
city: Hull
country: United Kingdom
facility: Local Institution - 0034
city: Liverpool
country: United Kingdom
facility: Local Institution - 0124
city: London
country: United Kingdom
facility: Local Institution - 0005
city: Southampton
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: