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Nonalcoholic Steatohepatitis (NASH)Phase 2NCT04267393

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

A Phase 2 study testing BMS-986263 in people with Nonalcoholic Steatohepatitis (NASH), run by Bristol-Myers Squibb at 112 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Nonalcoholic Steatohepatitis (NASH)
What is being tested?
BMS-986263
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
112 sitesin 16 countries
Study dates
17 Mar 2021to 9 Feb 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

112 sites in 16 countries.

112 sites in 16 countries

United States29 sites

  • Local Institution - 0150

    Baltimore, Maryland, 21202

  • Research Foundation of SUNY - University of Buffalo

    Buffalo, New York, 14203

  • Arizona Clinical Trials - Tucson

    Chandler, Arizona, 85224

  • Local Institution - 0173

    Chandler, Arizona, 85224

  • The Institute for Liver Health-The Institute for Liver Health

    Chandler, Arizona, 85224

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • Local Institution - 0171

    Dallas, Texas, 75203

  • Local Institution

    Fall River, Massachusetts, 02721

  • Local Institution - 0109

    Houston, Texas, 77030

  • Local Institution - 0121

    Iowa City, Iowa, 52242

  • Local Institution - 0077

    Kansas City, Missouri, 64111

  • Local Institution - 0140

    La Jolla, California, 92037

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Local Institution - 0205

    Lancaster, California, 93534

  • Local Institution - 0024

    Leesburg, Florida, 34748

  • GastroIntestinal BioSciences

    Los Angeles, California, 90067

  • Local Institution

    McAllen, Texas, 78504

  • Local Institution - 0061

    Miami, Florida, 33136

  • Local Institution - 0206

    Morehead City, North Carolina, 28557

  • NYU Langone Health-Department of Medicine

    New York, New York, 10016

  • Local Institution

    New York, New York, 10029

  • Local Institution - 0186

    Omaha, Nebraska, 68198

  • Local Institution - 0177

    Philadelphia, Pennsylvania, 19104

  • Local Institution - 0017

    Philadelphia, Pennsylvania, 19107

  • Local Institution

    Phoenix, Arizona, 85013

  • Local Institution - 0143

    Redwood City, California, 94063

  • Local Institution - 0122

    Richmond, Virginia, 232980341

  • Local Institution - 0013

    San Antonio, Texas, 78215

  • Local Institution - 0025

    Winter Park, Florida, 32789

Other trials in United States

Japan16 sites

  • Local Institution - 0199

    Aomori, 030-8553

  • Local Institution - 0125

    Bunkyō, Tokyo, 113-8519

  • Local Institution - 0193

    Gifu, 5008513

  • Local Institution - 0026

    Hiroshima, 7348551

  • Local Institution - 0135

    Kagoshima, 8908520

  • Local Institution - 0111

    Kashihara, Nara, 634-0813

  • Local Institution - 0048

    Kurume, Fukuoka, 830-0011

  • Local Institution - 0131

    Kyoto, 602-8566

  • Local Institution - 0155

    Matsumoto, Nagano, 390-8621

  • Local Institution - 0138

    Minato-ku, Tokyo, 105-8470

  • Local Institution - 0163

    Sakai, Osaka, 591-8025

  • Local Institution - 0049

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0127

    Shiwagun Yahabatyo, Iwate, 028-3695

  • Local Institution - 0200

    Tōon, Ehime, 791-0295

  • Local Institution - 0132

    Yamagata, 990-9585

  • Local Institution - 0075

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Brazil9 sites

  • Local Institution - 0187

    Barretos, São Paulo, 14780-320

  • Local Institution - 0182

    Bento Gonçalves, Rio Grande do Sul, 95700-084

  • Local Institution - 0188

    Botucatu, São Paulo, 18618.687

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035004

  • Local Institution

    Ribeirão Preto, São Paulo, 14049900

  • Local Institution - 0083

    Salvador, Estado de Bahia, 40110-060

  • Local Institution - 0196

    São Bernardo do Campo, São Paulo, 09715-090

  • Local Institution - 0120

    São Paulo, 01.308-050

  • Local Institution

    São Paulo, 05652000

Other trials in Brazil

Germany9 sites

  • Local Institution - 0091

    Berlin, 13353

  • Local Institution - 0099

    Essen, 45147

  • Local Institution - 0082

    Frankfurt am Main, Hesse, 60590

  • Local Institution - 0096

    Hanover, 30625

  • Local Institution - 0073

    Kiel, 24105

  • Local Institution - 0194

    Lübeck, 23538

  • Local Institution - 0071

    Mainz, 55131

  • Local Institution - 0060

    Munich, 81377

  • Local Institution - 0204

    Trier, 54292

Other trials in Germany

Spain9 sites

  • Local Institution - 0040

    Barcelona, 08035

  • Local Institution - 0080

    Madrid, 28007

  • Local Institution - 0039

    Madrid, 28034

  • Local Institution - 0038

    Madrid, 28222

  • Local Institution - 0036

    Málaga, 29010

  • Local Institution - 0037

    Santander, 39008

  • Local Institution - 0041

    Seville, 41013

  • Local Institution - 0035

    Valencia, 46010

  • Local Institution - 0043

    Valencia, 46026

Other trials in Spain

France7 sites

  • Local Institution - 0202

    Créteil, Île-de-France Region, 94000

  • Local Institution - 0094

    Lyon, 69004

  • Local Institution - 0031

    Nice, 06200

  • Local Institution - 0101

    Paris, 75013

  • Local Institution - 0105

    Paris, 75014

  • Local Institution - 0137

    Strasbourg, 67098

  • Local Institution - 0029

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Italy5 sites

  • Local Institution - 0054

    Bologna, 40138

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

    Messina, 0

  • Local Institution - 0115

    Palermo, 90127

  • Local Institution - 0051

    Pisa, 56124

  • Local Institution

    Rome, 168

Other trials in Italy

United Kingdom5 sites

  • Local Institution - 0034

    Hull, HU3 2JZ

  • Local Institution - 0124

    Liverpool, L9 7AL

  • Local Institution - 0005

    London, SE5 9RS

  • Local Institution - 0011

    Nottingham, Nottinghamshire, NG7 2UH

  • Local Institution

    Southampton, SO16 6YD

Other trials in United Kingdom

Argentina4 sites

  • Local Institution - 0059

    Buenos Aires, C1280AEB

  • Local Institution - 0089

    Ciudad de Buenos Aires, Buenos Aires, 1181

  • Local Institution - 0209

    Quilmes, Buenos Aires F.D., 1879

  • Local Institution - 0126

    San Juan Bautista, Buenos Aires, 1888

Other trials in Argentina

Israel4 sites

  • Local Institution - 0056

    Haifa, 3436212

  • Local Institution - 0076

    Petah Tikva, 4941492

  • Local Institution - 0058

    Ramat Gan, 5262100

  • Local Institution - 0057

    Tel Aviv, 6423906

Other trials in Israel

Taiwan4 sites

  • Local Institution - 0001

    Kaohsiung City, 807

  • Local Institution

    Taipei, 10002

  • Local Institution

    Taipei, 11217

  • Local Institution - 0004

    Taoyuan, 333

Other trials in Taiwan

Belgium3 sites

  • Local Institution - 0009

    Edegem, 2650

  • Local Institution - 0006

    Ghent, 9000

  • Local Institution - 0133

    Leuven, 3001

Other trials in Belgium

South Korea3 sites

  • Local Institution - 0093

    Incheon, Incheon-gwangyeoksi [Incheon], 22332

  • Local Institution - 0066

    Seodaemun-gu, 03722

  • Local Institution - 0090

    Seoul, 04401

Other trials in South Korea

Canada2 sites

  • Local Institution - 0097

    Toronto, Ontario, M6H 3M1

  • Local Institution - 0128

    Victoria, British Columbia, V8V 3M9

Other trials in Canada

Switzerland2 sites

  • Local Institution - 0074

    Bern, 3010

  • Local Institution - 0102

    Lugano, Canton Ticino, 6900

Other trials in Switzerland

Puerto Rico1 site

  • Local Institution - 0012

    San Juan, 00927

Other trials in Puerto Rico

About this study

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)

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).

Being tested
BMS-986263, Placebo
Keywords
Nonalcoholic Steatohepatitis, Liver Disease, NASH, Compensated cirrhosis
Medical subject headings
Non-alcoholic Fatty Liver Disease, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986263Drug

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT04267393
Study groupRoleWhat they receive
Dose A BMS-986263ExperimentalNot described
Receives: Drug: BMS-986263
Dose B BMS-986263ExperimentalNot described
Receives: Drug: BMS-986263
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 12 Weeks

Secondary outcomes (12)

  1. 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).

    Measured: 12 Weeks

  2. 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).

    Measured: 12 Weeks

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

    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

    Measured: 12 Weeks

  4. 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

    Measured: 12 Weeks

  5. 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.

    Measured: 12 Weeks

  6. 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.

    Measured: From First Treatment to end of Follow up (36 weeks)

  7. Number of Participants With Clinically Significant Changes in Clinical Laboratory Values.

    Investigators must document their review of each laboratory safety report. A central laboratory will perform the analyses and will provide reference ranges for these tests.

    clinical laboratory assessments analyzed: Hematology, Blood Chemistry, Urinalysis and a Metabolic Panel.

    Measured: From First Treatment to end of Follow up (36 weeks)

  8. Number of Participants With Clinically Significant Changes in Vitals Signs.

    Includes body temperature, respiratory rate, blood pressure, and heart rate. Blood pressure and heart rate should be measured after the participant has been resting quietly for at least 5 minutes.

    Measured: From First Treatment to end of Follow up (36 weeks)

  9. Number of Participants With Clinically Significant Changes in Physical Examination Findings.

    Physical examination includes body weight, height, and BMI (height and BMI calculation at screening only).

    Measured: From First Treatment to end of Follow up (36 weeks)

  10. Number of Participants With Clinically Significant Changes in Electrocardiogram Readings.

    Number of Participants with clinically significant changes in electrocardiogram readings.

    Measured: From First Treatment to end of Follow up (36 weeks)

  11. Number of Participants With Clinically Significant Changes in BMD.

    Bone Mineral Density(BMD) will be measured by a dual-energy X-ray absorptiometry (DXA) Scan.

    Measured: From First Treatment to end of Follow up (36 weeks)

  12. Plasma Concentration of BMS-986263 Components at the End of 12 Weeks or ETT.

    Plasma concentrations of BMS-986263 components: siRNA, DPD, HEDC, and S104.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2020
  2. Study start17 Mar 2021
  3. Primary completion16 Aug 2023
  4. Study completion9 Feb 2024

Why it stopped: Trial terminated because of lack of efficacy in the short term acute phase.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04267393
Sponsor's protocol ID
IM025-017
Other IDs
2019-003932-22, U1111-1241-4762, 2019
Status last verified
Aug 2024
First submitted
11 Feb 2020
Last updated
4 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986263 in people with Nonalcoholic Steatohepatitis (NASH), run by Bristol-Myers Squibb at 112 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Japan, Brazil, Germany, Spain and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04267393.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.

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