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

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)

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 Overview

• Status: Terminated
• Conditions: Nonalcoholic Steatohepatitis (NASH)
• Intervention / Treatment: Other: Placebo; Drug: BMS-986263

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1280AEB
    • Local Institution - 0059
  • Buenos Aires
    • Ciudad de Buenos Aires, Buenos Aires, Argentina, 1181
      • Local Institution - 0089
    • Florencio Varela, Buenos Aires, Argentina, 1888
      • Local Institution - 0126
  • Ciudad Autónoma De Buenos Aires
    • Quilmes, Ciudad Autónoma De Buenos Aires, Argentina, 1879
      • Local Institution - 0209
• Belgium
  • Edegem, Belgium, 2650
    • Local Institution - 0009
  • Gent, Belgium, 9000
    • Local Institution - 0006
  • Leuven, Belgium, 3001
    • Local Institution - 0133
• Brazil
  • Sao Paulo, Brazil, 01.308-050
    • Local Institution - 0120
  • Sao Paulo, Brazil, 05652000
    • Local Institution
  • Bahia
    • Salvador, Bahia, Brazil, 40110-060
      • Local Institution - 0083
  • RIO Grande DO SUL
    • Bento Goncalves, RIO Grande DO SUL, Brazil, 95700-084
      • Local Institution - 0182
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90035004
      • Local Institution
  • SAO Paulo
    • Barretos, SAO Paulo, Brazil, 14780-320
      • Local Institution - 0187
    • Botucatu, SAO Paulo, Brazil, 18618.687
      • Local Institution - 0188
    • Ribeirão Preto, SAO Paulo, Brazil, 14049900
      • Local Institution
• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8V 3M9
      • Local Institution - 0128
  • Ontario
    • Toronto, Ontario, Canada, M6H 3M1
      • Local Institution - 0097
• France
  • Lyon, France, 69004
    • Local Institution - 0094
  • Nice, France, 06200
    • Local Institution - 0031
  • Paris, France, 75013
    • Local Institution - 0101
  • Paris, France, 75014
    • Local Institution - 0105
  • Strasbourg, France, 67098
    • Local Institution - 0137
  • Vandoeuvre les Nancy, France, 54500
    • Local Institution - 0029
  • Île-de-France
    • Créteil, Île-de-France, France, 94000
      • Local Institution - 0202
• Germany
  • Berlin, Germany, 13353
    • Local Institution - 0091
  • Essen, Germany, 45147
    • Universitaetsklinikum Essen
  • Hannover, Germany, 30625
    • Local Institution - 0096
  • Kiel, Germany, 24105
    • Local Institution - 0073
  • Lübeck, Germany, 23538
    • Local Institution - 0194
  • Mainz, Germany, 55131
    • Local Institution - 0071
  • Munich, Germany, 81377
    • Local Institution - 0060
  • Trier, Germany, 54292
    • Local Institution - 0204
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Local Institution - 0082
• Israel
  • Haifa, Israel, 3436212
    • Local Institution - 0056
  • Petah Tikva, Israel, 4941492
    • Local Institution - 0076
  • Ramat Gan, Israel, 5262100
    • Local Institution - 0058
  • Tel Aviv, Israel, 6423906
    • Local Institution - 0057
• Italy
  • Bologna, Italy, 40138
    • Local Institution - 0054
  • Messina, Italy
    • Azienda Ospedaliera Universitaria Di Messina G. Martino-D.A.I. Medicina Interna
  • Palermo, Italy, 90127
    • A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic
  • Pisa, Italy, 56124
    • Azienda Ospedaliera Universitaria Pisana-U.O. Epatologia
  • Rome, Italy, 168
    • Local Institution
• Japan
  • Aomori, Japan, 030-8553
    • Local Institution - 0199
  • Gifu, Japan, 5008513
    • Local Institution - 0193
  • Hiroshima, Japan, 7348851
    • Local Institution - 0026
  • Kagoshima, Japan, 8908520
    • Local Institution - 0135
  • Kyoto, Japan, 602-8566
    • Local Institution - 0131
  • Toon, Japan, 791-0295
    • Local Institution - 0200
  • Yamagata, Japan, 990-9585
    • Local Institution - 0132
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Local Institution - 0048
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 0608648
      • Local Institution - 0049
  • Iwate
    • Shiwagun Yahabatyo, Iwate, Japan, 028-3695
      • Local Institution - 0127
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Local Institution - 0075
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Local Institution - 0155
  • Nara
    • Kashihara-shi, Nara, Japan, 6348522
      • Local Institution - 0111
  • Osaka
    • Sakai, Osaka, Japan, 591-8025
      • Local Institution - 0163
  • Tokyo
    • Bunkyō, Tokyo, Japan, 113-8519
      • Local Institution - 0125
    • Minato-ku, Tokyo, Japan, 105-8470
      • Local Institution - 0138
• Korea, Republic of
  • Seodaemun-gu, Korea, Republic of, 03722
    • Local Institution - 0066
  • Seoul, Korea, Republic of, 04401
    • Local Institution - 0090
  • Incheon-gwangyeoksi [Incheon]
    • Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 22332
      • Local Institution - 0093
• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • Local Institution - 0012
• Spain
  • Barcelona, Spain, 08035
    • Local Institution - 0040
  • Madrid, Spain, 28007
    • Local Institution - 0080
  • Madrid, Spain, 28222
    • Local Institution - 0038
  • Madrid, Spain, 28034
    • Local Institution - 0039
  • Malaga, Spain, 29010
    • Local Institution - 0036
  • Santander, Spain, 39008
    • Local Institution - 0037
  • Sevilla, Spain, 41013
    • Local Institution - 0041
  • Valencia, Spain, 46010
    • Local Institution - 0035
  • València, Spain, 46026
    • Local Institution - 0043
• Switzerland
  • Berne, Switzerland, 3010
    • Local Institution - 0074
  • Ticino
    • Lugano, Ticino, Switzerland, 6900
      • Local Institution - 0102
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Local Institution - 0001
  • Taipei, Taiwan, 11217
    • Local Institution
  • Taipei, Taiwan, 10002
    • Local Institution
  • Taoyuan, Taiwan, 333
    • Local Institution - 0004
• United Kingdom
  • Hull, United Kingdom, HU3 2JZ
    • Local Institution - 0034
  • Liverpool, United Kingdom, L9 7AL
    • Local Institution
  • London, United Kingdom, SE5 9RS
    • Local Institution - 0005
  • Southampton, United Kingdom, SO16 6YD
    • Local Institution
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Local Institution - 0011
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Arizona Clinical Trials - Tucson
    • Chandler, Arizona, United States, 85224
      • Local Institution - 0173
    • Chandler, Arizona, United States, 85224
      • The Institute for Liver Health-The Institute for Liver Health
    • Phoenix, Arizona, United States, 85013
      • Local Institution
  • California
    • La Jolla, California, United States, 92037
      • Local Institution - 0140
    • Lancaster, California, United States, 93534
      • Local Institution - 0205
    • Los Angeles, California, United States, 90067
      • GastroIntestinal BioSciences
    • Redwood City, California, United States, 94063
      • Local Institution - 0143
  • Florida
    • Lakewood Ranch, Florida, United States, 34211
      • Florida Research Institute
    • Leesburg, Florida, United States, 34748
      • Local Institution - 0024
    • Miami, Florida, United States, 33136
      • Local Institution - 0061
    • Winter Park, Florida, United States, 32789
      • Local Institution - 0025
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Local Institution - 0121
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Local Institution
  • Massachusetts
    • Fall River, Massachusetts, United States, 02721
      • Local Institution
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Local Institution - 0077
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Local Institution - 0186
  • New York
    • Buffalo, New York, United States, 14203
      • Research Foundation of SUNY - University of Buffalo
    • New York, New York, United States, 10029
      • Local Institution
    • New York, New York, United States, 10016
      • NYU Langone Health-Department of Medicine
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Local Institution - 0206
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Local Institution - 0177
    • Philadelphia, Pennsylvania, United States, 19107
      • Local Institution - 0017
  • Tennessee
    • Chattanooga, Tennessee, United States, 37411
      • University Diabetes & Endocrine Consultants
  • Texas
    • Dallas, Texas, United States, 75203
      • Local Institution
    • Houston, Texas, United States, 77030
      • Local Institution - 0109
    • McAllen, Texas, United States, 78504
      • Local Institution
    • San Antonio, Texas, United States, 78215
      • Local Institution - 0013
  • Virginia
    • Richmond, Virginia, United States, 232980341
      • Local Institution - 0122

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Specified dose on specified days
Experimental: Dose A BMS-986263	Drug: BMS-986263; Specified dose on specified days
Experimental: Dose B BMS-986263	Drug: BMS-986263; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Actual): August 16, 2023
• Study Completion (Actual): February 9, 2024

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Nonalcoholic Steatohepatitis; NASH; Liver Disease; Compensated cirrhosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: IM025-017; 2019-003932-22 (EudraCT Number); U1111-1241-4762 (Other Identifier: UTN Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No