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

NCT04267393 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: IM025-0172019-003932-22U1111-1241-4762
• Study Type: interventional
• Target: 124
• Locations: 16 countries
• Sites: 112

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).

Conditions

Nonalcoholic Steatohepatitis (NASH)

Keywords

Nonalcoholic Steatohepatitis; Liver Disease; NASH; Compensated cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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).

  12 Weeks

Secondary Outcomes (12)

• 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.

  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.

  12 Weeks

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

  12 Weeks

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

  12 Weeks

• Mean Change From Baseline in CPA After 12 Weeks of Treatment

  12 Weeks

Study Arms (3)

Dose A BMS-986263

EXPERIMENTAL

Drug: BMS-986263

Dose B BMS-986263

EXPERIMENTAL

Drug: BMS-986263

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

BMS-986263 DRUG

Specified dose on specified days

Dose A BMS-986263; Dose B BMS-986263

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (112)

Arizona Clinical Trials - Tucson

Chandler, Arizona, 85224, United States

Location

Local Institution - 0173

Chandler, Arizona, 85224, United States

Location

The Institute for Liver Health-The Institute for Liver Health

Chandler, Arizona, 85224, United States

Location

Local Institution

Phoenix, Arizona, 85013, United States

Location

Local Institution - 0140

La Jolla, California, 92037, United States

Location

Local Institution - 0205

Lancaster, California, 93534, United States

Location

GastroIntestinal BioSciences

Los Angeles, California, 90067, United States

Location

Local Institution - 0143

Redwood City, California, 94063, United States

Location

Florida Research Institute

Lakewood Rch, Florida, 34211, United States

Location

Local Institution - 0024

Leesburg, Florida, 34748, United States

Location

Local Institution - 0061

Miami, Florida, 33136, United States

Location

Local Institution - 0025

Winter Park, Florida, 32789, United States

Location

Local Institution - 0121

Iowa City, Iowa, 52242, United States

Location

Local Institution - 0150

Baltimore, Maryland, 21202, United States

Location

Local Institution

Fall River, Massachusetts, 02721, United States

Location

Local Institution - 0077

Kansas City, Missouri, 64111, United States

Location

Local Institution - 0186

Omaha, Nebraska, 68198, United States

Location

Research Foundation of SUNY - University of Buffalo

Buffalo, New York, 14203, United States

Location

NYU Langone Health-Department of Medicine

New York, New York, 10016, United States

Location

Local Institution

New York, New York, 10029, United States

Location

Local Institution - 0206

Morehead City, North Carolina, 28557, United States

Location

Local Institution - 0177

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 0017

Philadelphia, Pennsylvania, 19107, United States

Location

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Local Institution - 0171

Dallas, Texas, 75203, United States

Location

Local Institution - 0109

Houston, Texas, 77030, United States

Location

Local Institution

McAllen, Texas, 78504, United States

Location

Local Institution - 0013

San Antonio, Texas, 78215, United States

Location

Local Institution - 0122

Richmond, Virginia, 232980341, United States

Location

Local Institution - 0089

Ciudad de Buenos Aires, Buenos Aires, 1181, Argentina

Location

Local Institution - 0126

San Juan Bautista, Buenos Aires, 1888, Argentina

Location

Local Institution - 0209

Quilmes, Buenos Aires F.D., 1879, Argentina

Location

Local Institution - 0059

Buenos Aires, C1280AEB, Argentina

Location

Local Institution - 0009

Edegem, 2650, Belgium

Location

Local Institution - 0006

Ghent, 9000, Belgium

Location

Local Institution - 0133

Leuven, 3001, Belgium

Location

Local Institution - 0083

Salvador, Estado de Bahia, 40110-060, Brazil

Location

Local Institution - 0182

Bento Gonçalves, Rio Grande do Sul, 95700-084, Brazil

Location

Local Institution

Porto Alegre, Rio Grande do Sul, 90035004, Brazil

Location

Local Institution - 0187

Barretos, São Paulo, 14780-320, Brazil

Location

Local Institution - 0188

Botucatu, São Paulo, 18618.687, Brazil

Location

Local Institution

Ribeirão Preto, São Paulo, 14049900, Brazil

Location

Local Institution - 0196

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

Local Institution - 0120

São Paulo, 01.308-050, Brazil

Location

Local Institution

São Paulo, 05652000, Brazil

Location

Local Institution - 0128

Victoria, British Columbia, V8V 3M9, Canada

Location

Local Institution - 0097

Toronto, Ontario, M6H 3M1, Canada

Location

Local Institution - 0094

Lyon, 69004, France

Location

Local Institution - 0031

Nice, 06200, France

Location

Local Institution - 0101

Paris, 75013, France

Location

Local Institution - 0105

Paris, 75014, France

Location

Local Institution - 0137

Strasbourg, 67098, France

Location

Local Institution - 0029

Vandœuvre-lès-Nancy, 54500, France

Location

Local Institution - 0202

Créteil, Île-de-France Region, 94000, France

Location

Local Institution - 0082

Frankfurt am Main, Hesse, 60590, Germany

Location

Local Institution - 0091

Berlin, 13353, Germany

Location

Local Institution - 0099

Essen, 45147, Germany

Location

Local Institution - 0096

Hanover, 30625, Germany

Location

Local Institution - 0073

Kiel, 24105, Germany

Location

Local Institution - 0194

Lübeck, 23538, Germany

Location

Local Institution - 0071

Mainz, 55131, Germany

Location

Local Institution - 0060

Munich, 81377, Germany

Location

Local Institution - 0204

Trier, 54292, Germany

Location

Local Institution - 0056

Haifa, 3436212, Israel

Location

Local Institution - 0076

Petah Tikva, 4941492, Israel

Location

Local Institution - 0058

Ramat Gan, 5262100, Israel

Location

Local Institution - 0057

Tel Aviv, 6423906, Israel

Location

Local Institution - 0054

Bologna, 40138, Italy

Location

Azienda Ospedaliera Universitaria Di Messina G. Martino-D.A.I. Medicina Interna

Messina, 0, Italy

Location

Local Institution - 0115

Palermo, 90127, Italy

Location

Local Institution - 0051

Pisa, 56124, Italy

Location

Local Institution

Rome, 168, Italy

Location

Local Institution - 0200

Tōon, Ehime, 791-0295, Japan

Location

Local Institution - 0048

Kurume, Fukuoka, 830-0011, Japan

Location

Local Institution - 0049

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 0127

Shiwagun Yahabatyo, Iwate, 028-3695, Japan

Location

Local Institution - 0075

Yokohama, Kanagawa, 236-0004, Japan

Location

Local Institution - 0155

Matsumoto, Nagano, 390-8621, Japan

Location

Local Institution - 0111

Kashihara, Nara, 634-0813, Japan

Location

Local Institution - 0163

Sakai, Osaka, 591-8025, Japan

Location

Local Institution - 0125

Bunkyō, Tokyo, 113-8519, Japan

Location

Local Institution - 0138

Minato-ku, Tokyo, 105-8470, Japan

Location

Local Institution - 0199

Aomori, 030-8553, Japan

Location

Local Institution - 0193

Gifu, 5008513, Japan

Location

Local Institution - 0026

Hiroshima, 7348551, Japan

Location

Local Institution - 0135

Kagoshima, 8908520, Japan

Location

Local Institution - 0131

Kyoto, 602-8566, Japan

Location

Local Institution - 0132

Yamagata, 990-9585, Japan

Location

Local Institution - 0012

San Juan, 00927, Puerto Rico

Location

Local Institution - 0093

Incheon, Incheon-gwangyeoksi [Incheon], 22332, South Korea

Location

Local Institution - 0066

Seodaemun-gu, 03722, South Korea

Location

Local Institution - 0090

Seoul, 04401, South Korea

Location

Local Institution - 0040

Barcelona, 08035, Spain

Location

Local Institution - 0080

Madrid, 28007, Spain

Location

Local Institution - 0039

Madrid, 28034, Spain

Location

Local Institution - 0038

Madrid, 28222, Spain

Location

Local Institution - 0036

Málaga, 29010, Spain

Location

Local Institution - 0037

Santander, 39008, Spain

Location

Local Institution - 0041

Seville, 41013, Spain

Location

Local Institution - 0035

Valencia, 46010, Spain

Location

Local Institution - 0043

Valencia, 46026, Spain

Location

Local Institution - 0102

Lugano, Canton Ticino, 6900, Switzerland

Location

Local Institution - 0074

Bern, 3010, Switzerland

Location

Local Institution - 0001

Kaohsiung City, 807, Taiwan

Location

Local Institution

Taipei, 10002, Taiwan

Location

Local Institution

Taipei, 11217, Taiwan

Location

Local Institution - 0004

Taoyuan District, 333, Taiwan

Location

Local Institution - 0011

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Local Institution - 0034

Hull, HU3 2JZ, United Kingdom

Location

Local Institution - 0124

Liverpool, L9 7AL, United Kingdom

Location

Local Institution - 0005

London, SE5 9RS, United Kingdom

Location

Local Institution

Southampton, SO16 6YD, United Kingdom

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases

Condition Hierarchy (Ancestors)

Fatty Liver; Digestive System Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 12, 2020
• Study Start: March 17, 2021
• Primary Completion: August 16, 2023
• Study Completion: February 9, 2024
• Last Updated: September 4, 2024
• Results First Posted: September 4, 2024

Record last verified: 2024-08

Locations

FR (7); US (29); TW (4); BR (9); JP (16); DE (9); KR (3); CA (2); GB (5); BE (3); IL (4); IT (5); CH (2); ES (9); AR (4); PR (1)