Nonalcoholic Steatohepatitis (NASH) Clinical Trial
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)
| Verified date | February 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 124 |
| Est. completion date | February 9, 2024 |
| Est. primary completion date | August 16, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0059 | Buenos Aires | |
| Argentina | Local Institution - 0089 | Ciudad de Buenos Aires | Buenos Aires |
| Argentina | Local Institution - 0126 | Florencio Varela | Buenos Aires |
| Argentina | Local Institution - 0209 | Quilmes | Ciudad Autónoma De Buenos Aires |
| Belgium | Local Institution - 0009 | Edegem | |
| Belgium | Local Institution - 0006 | Gent | |
| Belgium | Local Institution - 0133 | Leuven | |
| Brazil | Local Institution - 0187 | Barretos | SAO Paulo |
| Brazil | Local Institution - 0182 | Bento Goncalves | RIO Grande DO SUL |
| Brazil | Local Institution - 0188 | Botucatu | SAO Paulo |
| Brazil | Local Institution | Porto Alegre | RIO Grande DO SUL |
| Brazil | Local Institution | Ribeirão Preto | SAO Paulo |
| Brazil | Local Institution - 0083 | Salvador | Bahia |
| Brazil | Local Institution | Sao Paulo | |
| Brazil | Local Institution - 0120 | Sao Paulo | |
| Canada | Local Institution - 0097 | Toronto | Ontario |
| Canada | Local Institution - 0128 | Victoria | British Columbia |
| France | Local Institution - 0202 | Créteil | Île-de-France |
| France | Local Institution - 0094 | Lyon | |
| France | Local Institution - 0031 | Nice | |
| France | Local Institution - 0101 | Paris | |
| France | Local Institution - 0105 | Paris | |
| France | Local Institution - 0137 | Strasbourg | |
| France | Local Institution - 0029 | Vandoeuvre les Nancy | |
| Germany | Local Institution - 0091 | Berlin | |
| Germany | Universitaetsklinikum Essen | Essen | |
| Germany | Local Institution - 0082 | Frankfurt | Hessen |
| Germany | Local Institution - 0096 | Hannover | |
| Germany | Local Institution - 0073 | Kiel | |
| Germany | Local Institution - 0194 | Lübeck | |
| Germany | Local Institution - 0071 | Mainz | |
| Germany | Local Institution - 0060 | Munich | |
| Germany | Local Institution - 0204 | Trier | |
| Israel | Local Institution - 0056 | Haifa | |
| Israel | Local Institution - 0076 | Petah Tikva | |
| Israel | Local Institution - 0058 | Ramat Gan | |
| Israel | Local Institution - 0057 | Tel Aviv | |
| Italy | Local Institution - 0054 | Bologna | |
| Italy | Azienda Ospedaliera Universitaria Di Messina G. Martino-D.A.I. Medicina Interna | Messina | |
| Italy | A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic | Palermo | |
| Italy | Azienda Ospedaliera Universitaria Pisana-U.O. Epatologia | Pisa | |
| Italy | Local Institution | Rome | |
| Japan | Local Institution - 0199 | Aomori | |
| Japan | Local Institution - 0125 | Bunkyo | Tokyo |
| Japan | Local Institution - 0193 | Gifu | |
| Japan | Local Institution - 0026 | Hiroshima | |
| Japan | Local Institution - 0135 | Kagoshima | |
| Japan | Local Institution - 0111 | Kashihara-shi | Nara |
| Japan | Local Institution - 0048 | Kurume | Fukuoka |
| Japan | Local Institution - 0131 | Kyoto | |
| Japan | Local Institution - 0155 | Matsumoto | Nagano |
| Japan | Local Institution - 0138 | Minato-ku | Tokyo |
| Japan | Local Institution - 0163 | Sakai | Osaka |
| Japan | Local Institution - 0049 | Sapporo | Hokkaido |
| Japan | Local Institution - 0127 | Shiwagun Yahabatyo | Iwate |
| Japan | Local Institution - 0200 | Toon | |
| Japan | Local Institution - 0132 | Yamagata | |
| Japan | Local Institution - 0075 | Yokohama | Kanagawa |
| Korea, Republic of | Local Institution - 0093 | Incheon | Incheon-gwangyeoksi [Incheon] |
| Korea, Republic of | Local Institution - 0066 | Seodaemun-gu | |
| Korea, Republic of | Local Institution - 0090 | Seoul | |
| Puerto Rico | Local Institution - 0012 | San Juan | |
| Spain | Local Institution - 0040 | Barcelona | |
| Spain | Local Institution - 0038 | Madrid | |
| Spain | Local Institution - 0039 | Madrid | |
| Spain | Local Institution - 0080 | Madrid | |
| Spain | Local Institution - 0036 | Malaga | |
| Spain | Local Institution - 0037 | Santander | |
| Spain | Local Institution - 0041 | Sevilla | |
| Spain | Local Institution - 0035 | Valencia | |
| Spain | Local Institution - 0043 | València | |
| Switzerland | Local Institution - 0074 | Berne | |
| Switzerland | Local Institution - 0102 | Lugano | Ticino |
| Taiwan | Local Institution - 0001 | Kaohsiung | |
| Taiwan | Local Institution | Taipei | |
| Taiwan | Local Institution | Taipei | |
| Taiwan | Local Institution - 0004 | Taoyuan | |
| United Kingdom | Local Institution - 0034 | Hull | |
| United Kingdom | Local Institution | Liverpool | |
| United Kingdom | Local Institution - 0005 | London | |
| United Kingdom | Local Institution - 0011 | Nottingham | Nottinghamshire |
| United Kingdom | Local Institution | Southampton | |
| United States | Local Institution | Baltimore | Maryland |
| United States | Research Foundation of SUNY - University of Buffalo | Buffalo | New York |
| United States | Arizona Clinical Trials - Tucson | Chandler | Arizona |
| United States | Local Institution - 0173 | Chandler | Arizona |
| United States | The Institute for Liver Health-The Institute for Liver Health | Chandler | Arizona |
| United States | University Diabetes & Endocrine Consultants | Chattanooga | Tennessee |
| United States | Local Institution | Dallas | Texas |
| United States | Local Institution | Fall River | Massachusetts |
| United States | Local Institution - 0109 | Houston | Texas |
| United States | Local Institution - 0121 | Iowa City | Iowa |
| United States | Local Institution - 0077 | Kansas City | Missouri |
| United States | Local Institution - 0140 | La Jolla | California |
| United States | Florida Research Institute | Lakewood Ranch | Florida |
| United States | Local Institution - 0205 | Lancaster | California |
| United States | Local Institution - 0024 | Leesburg | Florida |
| United States | GastroIntestinal BioSciences | Los Angeles | California |
| United States | Local Institution | McAllen | Texas |
| United States | Local Institution - 0061 | Miami | Florida |
| United States | Local Institution - 0206 | Morehead City | North Carolina |
| United States | Local Institution | New York | New York |
| United States | NYU Langone Health-Department of Medicine | New York | New York |
| United States | Local Institution - 0186 | Omaha | Nebraska |
| United States | Local Institution - 0017 | Philadelphia | Pennsylvania |
| United States | Local Institution - 0177 | Philadelphia | Pennsylvania |
| United States | Local Institution | Phoenix | Arizona |
| United States | Local Institution - 0143 | Redwood City | California |
| United States | Local Institution - 0122 | Richmond | Virginia |
| United States | Local Institution - 0013 | San Antonio | Texas |
| United States | Local Institution - 0025 | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Japan, Korea, Republic of, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of participants who achieve = 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score) | At 12 weeks | ||
| Secondary | 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 | ||
| Secondary | Proportion of participants with = 2 stage improvement in liver fibrosis score (NASH CRN Fibrosis Score) | At 12 weeks | ||
| Secondary | Proportion of participants with = 1 stage improvement in modified Ishak liver fibrosis score | At 12 weeks | ||
| Secondary | Proportion of participants with = 2 stage improvement in modified Ishak liver fibrosis score | At 12 weeks | ||
| Secondary | Change from baseline in collagen proportionate area (CPA) | At 12 weeks | ||
| Secondary | Incidence of Adverse Events (AEs) | Up to week 36 | ||
| Secondary | Incidence of Serious Adverse Events (SAEs) | Up to week 36 | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory values: Hematology tests | Up to week 36 | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests | Up to week 36 | ||
| Secondary | Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests | Up to week 36 | ||
| Secondary | Incidence of clinically significant changes in vital signs: Body temperature | Up to week 36 | ||
| Secondary | Incidence of clinically significant changes in vital signs: Respiratory rate | Up to week 36 | ||
| Secondary | Incidence of clinically significant changes in vital signs: Blood pressure | Up to week 36 | ||
| Secondary | Incidence of clinically significant changes in vital signs: Heart rate | Up to week 36 | ||
| Secondary | Incidence of clinically significant changes in electrocardiogram (ECG) parameters: Mean heart rate | Up to week 36 | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Incidence of clinically significant changes in physical examination | Up to week 36 | ||
| Secondary | Change from baseline in bone mineral density (BMD), as measured by dual-energy x-ray absorptiometry (DXA) scan | Up to week 36 | ||
| Secondary | Plasma concentrations of components of BMS-986263 for injection | Day 1 to week 12 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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