This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

  • Clinicaltrials.gov identifier

    NCT04267393

  • Recruitment Status

    Recruiting

  • First Posted

    February 12, 2020

  • Last update posted

    October 18, 2021

Study Description

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).

  • Condition or Disease:Nonalcoholic Steatohepatitis (NASH)
  • Intervention/Treatment: Drug: BMS-986263
    Other: Placebo
  • Phase: Phase 2

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 270 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • 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)
  • Actual Study Start Date: March 2021
  • Estimated Primary Completion Date: July 2023
  • Estimated Study Completion Date: January 2024

Arms and interventions

Arm Intervention/treatment
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
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Proportion of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score) [ Time Frame: At 12 weeks ]
  • Secondary Outcome Measures: 1. 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 [ Time Frame: At 12 weeks ]
  • 2. Proportion of participants with ≥ 2 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score) [ Time Frame: At 12 weeks ]
  • 3. Proportion of participants with ≥ 1 stage improvement in modified Ishak liver fibrosis score [ Time Frame: At 12 weeks ]
  • 4. Proportion of participants with ≥ 2 stage improvement in modified Ishak liver fibrosis score [ Time Frame: At 12 weeks ]
  • 5. Change from baseline in collagen proportionate area (CPA) [ Time Frame: At 12 weeks ]
  • 6. Incidence of Adverse Events (AEs) [ Time Frame: Up to week 36 ]
  • 7. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to week 36 ]
  • 8. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: Up to week 36 ]
  • 9. Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests [ Time Frame: Up to week 36 ]
  • 10. Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests [ Time Frame: Up to week 36 ]
  • 11. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to week 36 ]
  • 12. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to week 36 ]
  • 13. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to week 36 ]
  • 14. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to week 36 ]
  • 15. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: Mean heart rate [ Time Frame: Up to week 36 ]
  • 16. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [ Time Frame: Up to week 36 ]
    PR interval: The time from the onset of the P wave to the start of the QRS complex
  • 17. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [ Time Frame: Up to week 36 ]
    QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
  • 18. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [ Time Frame: Up to week 36 ]
    QT interval: Measured from the beginning of the QRS complex to the end of the T wave
  • 19. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcB interval [ Time Frame: Up to week 36 ]
    QTcB interval: Corrected QT interval using Bazett's formula (QTcB)
  • 20. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [ Time Frame: Up to week 36 ]
    QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
  • 21. Incidence of clinically significant changes in physical examination [ Time Frame: Up to week 36 ]
  • 22. Change from baseline in bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DXA) scan [ Time Frame: Up to week 36 ]
  • 23. Plasma concentrations of small interfering ribonucleic acid (siRNA) [ Time Frame: Day 1 to week 12 ]
  • 24. Plasma concentrations of di-retinamide-PEG-di-retinamide (DPD) [ Time Frame: Day 1 to week 12 ]
  • 25. Plasma Concentrations of ({Bis[2-(tetradecanoyloxy)ethyl] carbamoyl}methyl)-(2-hydroxyethyl) dimethylazanium bromide (HEDC) [ Time Frame: Day 1 to week 12 ]
  • 26. Plasma concentrations of lipid component (S104) [ Time Frame: Day 1 to week 12 ]

Eligibility Criteria

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

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 6 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

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

Japan
Local Institution
Kagoshima

Japan, Fukuoka
Local Institution
Kurume

Japan, Hiroshima
Local Institution
Hiroshima-shi

Japan, Hokkaido
Local Institution
Sapporo

Japan, Iwate
Local Institution
Shiwa-gun

Japan, Kanagawa
Local Institution
Yokohama

Japan, Kyoto
Local Institution
Kyoto-shi

Japan, Nagano
Local Institution
Matsumoto

Japan, Nara
Local Institution
Kashihara-shi

Japan, Osaka
Local Institution
Sakai

Japan, Tokyo
Local Institution
Minato-ku

Japan
Local Institution
Tokyo

Japan
Local Institution
Yamagata

United States, Arizona
Local Institution
Phoenix

United States, Arizona
Local Institution
Phoenix

United States, Arkansas
Local Institution
Little Rock

United States, California
Local Institution
Redwood City

United States, California
Local Institution
San Diego

United States, Connecticut
Local Institution
Bridgeport

United States, Florida
Local Institution
Leesburg

United States, Florida
Schiff Center for Liver Diseases
Miami

United States, Florida
Clinical Site Partners - Orlando
Winter Park

United States, Iowa
Local Institution
Iowa City

United States, Louisiana
Local Institution
Lake Charles

United States, Maryland
Local Institution
Baltimore

United States, Massachusetts
Local Institution
Fall River

United States, Michigan
Local Institution
Wyoming

United States, Missouri
Local Institution
Kansas City

United States, New York
Local Institution
New York

United States, Ohio
Local Institution
Middleburg Heights

United States, Pennsylvania
Local Institution
Philadelphia

United States, Pennsylvania
Local Institution
Philadelphia

United States, Pennsylvania
Local Institution
Philadelphia

United States, Tennessee
Local Institution
Memphis

United States, Texas
Local Institution
Dallas

United States, Texas
Local Institution
Houston

United States, Texas
Local Institution
Houston

United States, Texas
Local Institution
McAllen

United States, Texas
Texas Liver Institute
San Antonio

United States, Virginia
Local Institution
Richmond

Argentina, Buenos Aires
Local Institution
Ciudad Autonoma de Buenos Aires

Argentina, Buenos Aires
Local Institution
Florencio Varela

Argentina, Distrito Federal
Local Institution
Ciudad Autónoma de Buenos Aires

Belgium
Local Institution
Anderlecht

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
Edegem

Belgium
Local Institution
Gent

Belgium
Local Institution
Leuven

Brazil, Bahia
Local Institution
Salvador

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, SAO Paulo
Local Institution
São Paulo

Brazil
Local Institution
Sao Paulo

Brazil
Local Institution
Sao Paulo

Canada, British Columbia
Local Institution
Victoria

Canada, Ontario
Local Institution
Toronto

Germany
Charité Campus Virchow-Klinikum-Hepatology
Berlin

Germany
Local Institution
Bonn

Germany
Universitaetsklinikum Essen
Essen

Germany
Universitatsklinikum Frankfurt, Medizinische Klinik 1
Frankfurt

Germany
Local Institution
Hannover

Germany
Local Institution
Homburg

Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel-Allgemeine Innere Medizin I
Kiel

Germany
Klinikum D. Joh.-Gutenb.-Uni
Mainz

Germany
Local Institution
Munich

Israel
Local Institution
Haifa

Israel
Local Institution
Petach-Tikva

Israel
Local Institution
Ramat-gan

Israel
Local Institution
Tel Aviv

Italy
Local Institution
Bologna

Italy
Local Institution
Messina

Italy
A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic
Palermo

Italy
Local Institution
Pisa

Italy
Local Institution
Rome

Korea, Republic of
Local Institution
Incheon

Korea, Republic of
Local Institution
Seodaemun-gu

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Puerto Rico
Fundacion De Investigacion De Diego
San juan

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Malaga

Spain
Local Institution
Santander

Spain
Local Institution
Sevilla

Spain
Local Institution
Valencia

Spain
Local Institution
Valencia

Switzerland
Inselspital Bern-Universitätsklinik für Viszerale Chirurgie und Medizin
Bern

Switzerland
Local Institution
Lugano

Taiwan
Local Institution
Kaohsiung

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taipei

Taiwan
Local Institution
Taoyuan

United Kingdom
Local Institution
Hull

United Kingdom
Local Institution
Liverpool

United Kingdom
Local Institution
London

United Kingdom
Local Institution
London

United Kingdom
Local Institution
Nottingham

United Kingdom
Local Institution
Southampton

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04267393 History of Changes
  • Other Study ID Numbers: IM025-017, 2019-003932-22, U1111-1241-4762
  • First Posted: February 12, 2020 Key Record Dates
  • Last Update Posted: October 18, 2021
  • Last Verified: October 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Compensated cirrhosis
    NASH
    Liver Disease
    Nonalcoholic Steatohepatitis
  • Additional relevant MeSH terms: Fibrosis
    Non-alcoholic Fatty Liver Disease
    Fatty Liver
    Liver Cirrhosis