Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003932-22 | EudraCT Number | ||
| U1111-1241-4762 | Other Identifier | UTN Number |
Not provided
Not provided
Not provided
Trial terminated because of lack of efficacy in the short term acute phase.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A BMS-986263 | Experimental |
| |
| Dose B BMS-986263 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986263 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Trials - Tucson | Chandler | Arizona | 85224 | United States | ||
| Local Institution - 0173 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo |
| FG001 | Treatment 1 | BMS-986263 45mg QW |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomization |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 13, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Other |
Specified dose on specified days |
|
| 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. | 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). | 12 Weeks |
| 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
| 12 Weeks |
| 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
| 12 Weeks |
| 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. | 12 Weeks |
| 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. | From First Treatment to end of Follow up (36 weeks) |
| 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. | From First Treatment to end of Follow up (36 weeks) |
| 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. | From First Treatment to end of Follow up (36 weeks) |
| 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). | From First Treatment to end of Follow up (36 weeks) |
| Number of Participants With Clinically Significant Changes in Electrocardiogram Readings. | Number of Participants with clinically significant changes in electrocardiogram readings. | From First Treatment to end of Follow up (36 weeks) |
| 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. | From First Treatment to end of Follow up (36 weeks) |
| 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. | 12 Weeks |
| Chandler |
| Arizona |
| 85224 |
| United States |
| The Institute for Liver Health-The Institute for Liver Health | Chandler | Arizona | 85224 | United States |
| Local Institution | Phoenix | Arizona | 85013 | United States |
| Local Institution - 0140 | La Jolla | California | 92037 | United States |
| Local Institution - 0205 | Lancaster | California | 93534 | United States |
| GastroIntestinal BioSciences | Los Angeles | California | 90067 | United States |
| Local Institution - 0143 | Redwood City | California | 94063 | United States |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | United States |
| Local Institution - 0024 | Leesburg | Florida | 34748 | United States |
| Local Institution - 0061 | Miami | Florida | 33136 | United States |
| Local Institution - 0025 | Winter Park | Florida | 32789 | United States |
| Local Institution - 0121 | Iowa City | Iowa | 52242 | United States |
| Local Institution - 0150 | Baltimore | Maryland | 21202 | United States |
| Local Institution | Fall River | Massachusetts | 02721 | United States |
| Local Institution - 0077 | Kansas City | Missouri | 64111 | United States |
| Local Institution - 0186 | Omaha | Nebraska | 68198 | United States |
| Research Foundation of SUNY - University of Buffalo | Buffalo | New York | 14203 | United States |
| NYU Langone Health-Department of Medicine | New York | New York | 10016 | United States |
| Local Institution | New York | New York | 10029 | United States |
| Local Institution - 0206 | Morehead City | North Carolina | 28557 | United States |
| Local Institution - 0177 | Philadelphia | Pennsylvania | 19104 | United States |
| Local Institution - 0017 | Philadelphia | Pennsylvania | 19107 | United States |
| University Diabetes & Endocrine Consultants | Chattanooga | Tennessee | 37411 | United States |
| Local Institution - 0171 | Dallas | Texas | 75203 | United States |
| Local Institution - 0109 | Houston | Texas | 77030 | United States |
| Local Institution | McAllen | Texas | 78504 | United States |
| Local Institution - 0013 | San Antonio | Texas | 78215 | United States |
| Local Institution - 0122 | Richmond | Virginia | 232980341 | United States |
| Local Institution - 0089 | Ciudad de Buenos Aires | Buenos Aires | 1181 | Argentina |
| Local Institution - 0126 | San Juan Bautista | Buenos Aires | 1888 | Argentina |
| Local Institution - 0209 | Quilmes | Buenos Aires F.D. | 1879 | Argentina |
| Local Institution - 0059 | Buenos Aires | C1280AEB | Argentina |
| Local Institution - 0009 | Edegem | 2650 | Belgium |
| Local Institution - 0006 | Ghent | 9000 | Belgium |
| Local Institution - 0133 | Leuven | 3001 | Belgium |
| Local Institution - 0083 | Salvador | Estado de Bahia | 40110-060 | Brazil |
| Local Institution - 0182 | Bento Gonçalves | Rio Grande do Sul | 95700-084 | Brazil |
| Local Institution | Porto Alegre | Rio Grande do Sul | 90035004 | Brazil |
| Local Institution - 0187 | Barretos | São Paulo | 14780-320 | Brazil |
| Local Institution - 0188 | Botucatu | São Paulo | 18618.687 | Brazil |
| Local Institution | Ribeirão Preto | São Paulo | 14049900 | Brazil |
| Local Institution - 0196 | São Bernardo do Campo | São Paulo | 09715-090 | Brazil |
| Local Institution - 0120 | São Paulo | 01.308-050 | Brazil |
| Local Institution | São Paulo | 05652000 | Brazil |
| Local Institution - 0128 | Victoria | British Columbia | V8V 3M9 | Canada |
| Local Institution - 0097 | Toronto | Ontario | M6H 3M1 | Canada |
| Local Institution - 0094 | Lyon | 69004 | France |
| Local Institution - 0031 | Nice | 06200 | France |
| Local Institution - 0101 | Paris | 75013 | France |
| Local Institution - 0105 | Paris | 75014 | France |
| Local Institution - 0137 | Strasbourg | 67098 | France |
| Local Institution - 0029 | Vandœuvre-lès-Nancy | 54500 | France |
| Local Institution - 0202 | Créteil | Île-de-France Region | 94000 | France |
| Local Institution - 0082 | Frankfurt am Main | Hesse | 60590 | Germany |
| Local Institution - 0091 | Berlin | 13353 | Germany |
| Local Institution - 0099 | Essen | 45147 | Germany |
| Local Institution - 0096 | Hanover | 30625 | Germany |
| Local Institution - 0073 | Kiel | 24105 | Germany |
| Local Institution - 0194 | Lübeck | 23538 | Germany |
| Local Institution - 0071 | Mainz | 55131 | Germany |
| Local Institution - 0060 | Munich | 81377 | Germany |
| Local Institution - 0204 | Trier | 54292 | Germany |
| Local Institution - 0056 | Haifa | 3436212 | Israel |
| Local Institution - 0076 | Petah Tikva | 4941492 | Israel |
| Local Institution - 0058 | Ramat Gan | 5262100 | Israel |
| Local Institution - 0057 | Tel Aviv | 6423906 | Israel |
| Local Institution - 0054 | Bologna | 40138 | Italy |
| Azienda Ospedaliera Universitaria Di Messina G. Martino-D.A.I. Medicina Interna | Messina | 0 | Italy |
| Local Institution - 0115 | Palermo | 90127 | Italy |
| Local Institution - 0051 | Pisa | 56124 | Italy |
| Local Institution | Rome | 168 | Italy |
| Local Institution - 0200 | Tōon | Ehime | 791-0295 | Japan |
| Local Institution - 0048 | Kurume | Fukuoka | 830-0011 | Japan |
| Local Institution - 0049 | Sapporo | Hokkaido | 0608648 | Japan |
| Local Institution - 0127 | Shiwagun Yahabatyo | Iwate | 028-3695 | Japan |
| Local Institution - 0075 | Yokohama | Kanagawa | 236-0004 | Japan |
| Local Institution - 0155 | Matsumoto | Nagano | 390-8621 | Japan |
| Local Institution - 0111 | Kashihara | Nara | 634-0813 | Japan |
| Local Institution - 0163 | Sakai | Osaka | 591-8025 | Japan |
| Local Institution - 0125 | Bunkyō | Tokyo | 113-8519 | Japan |
| Local Institution - 0138 | Minato-ku | Tokyo | 105-8470 | Japan |
| Local Institution - 0199 | Aomori | 030-8553 | Japan |
| Local Institution - 0193 | Gifu | 5008513 | Japan |
| Local Institution - 0026 | Hiroshima | 7348551 | Japan |
| Local Institution - 0135 | Kagoshima | 8908520 | Japan |
| Local Institution - 0131 | Kyoto | 602-8566 | Japan |
| Local Institution - 0132 | Yamagata | 990-9585 | Japan |
| Local Institution - 0012 | San Juan | 00927 | Puerto Rico |
| Local Institution - 0093 | Incheon | Incheon-gwangyeoksi [Incheon] | 22332 | South Korea |
| Local Institution - 0066 | Seodaemun-gu | 03722 | South Korea |
| Local Institution - 0090 | Seoul | 04401 | South Korea |
| Local Institution - 0040 | Barcelona | 08035 | Spain |
| Local Institution - 0080 | Madrid | 28007 | Spain |
| Local Institution - 0039 | Madrid | 28034 | Spain |
| Local Institution - 0038 | Madrid | 28222 | Spain |
| Local Institution - 0036 | Málaga | 29010 | Spain |
| Local Institution - 0037 | Santander | 39008 | Spain |
| Local Institution - 0041 | Seville | 41013 | Spain |
| Local Institution - 0035 | Valencia | 46010 | Spain |
| Local Institution - 0043 | Valencia | 46026 | Spain |
| Local Institution - 0102 | Lugano | Canton Ticino | 6900 | Switzerland |
| Local Institution - 0074 | Bern | 3010 | Switzerland |
| Local Institution - 0001 | Kaohsiung City | 807 | Taiwan |
| Local Institution | Taipei | 10002 | Taiwan |
| Local Institution | Taipei | 11217 | Taiwan |
| Local Institution - 0004 | Taoyuan | 333 | Taiwan |
| Local Institution - 0011 | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| Local Institution - 0034 | Hull | HU3 2JZ | United Kingdom |
| Local Institution - 0124 | Liverpool | L9 7AL | United Kingdom |
| Local Institution - 0005 | London | SE5 9RS | United Kingdom |
| Local Institution | Southampton | SO16 6YD | United Kingdom |
| Treatment 2 |
BMS-986263 90mg QW |
| COMPLETED | = Randomized and Treated |
|
| NOT COMPLETED |
|
|
| Treatment Period |
|
|
All Randomized Participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | Treatment 1 | BMS-986263 45mg QW |
| BG002 | Treatment 2 | BMS-986263 90mg QW |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Modified Intent to Treat Population (mITT) | Posted | Number | Percentage | 12 Weeks |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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). | mITT population | Posted | Number | Percentage | 12 Weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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). | mITT Population | Posted | Number | Percentage | 12 Weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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
| mITT Population | Posted | Number | Percentage | 12 Weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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
| mITT Population | Posted | Number | Percentage | 12 Weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | Total number of evaluable participants are those who have both baseline and Week 12/ETT biopsy available | Posted | Mean | Standard Error | Percentage | 12 Weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | All Treated Participants | Posted | Count of Participants | Participants | From First Treatment to end of Follow up (36 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | All Treated Participants | Posted | Count of Participants | Participants | From First Treatment to end of Follow up (36 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | All Treated Participants | Posted | Count of Participants | Participants | From First Treatment to end of Follow up (36 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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). | All Treated Participants | Posted | Count of Participants | Participants | From First Treatment to end of Follow up (36 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Electrocardiogram Readings. | Number of Participants with clinically significant changes in electrocardiogram readings. | All Treated Participants | Posted | Count of Participants | Participants | From First Treatment to end of Follow up (36 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | All Treated Participants | Posted | Count of Participants | Participants | From First Treatment to end of Follow up (36 weeks) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | All participants who receive at least 1 dose of BMS-986263 and have any available concentration-time data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 12 Weeks |
|
|
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication Adverse Events and Serious Adverse Events: (From first dose to last dose + 24 week follow up): Approximately 36 Weeks All-Cause mortality (From randomization to end of study): Approximately 42 Weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo QW | 0 | 39 | 1 | 39 | 17 | 39 |
| EG001 | Treatment 1 | BMS-986263 45mg QW | 0 | 41 | 1 | 41 | 24 | 41 |
| EG002 | Treatment 2 | BMS-986263 90mg QW | 0 | 42 | 2 | 42 | 29 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Aug 9, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Administrative Reasons by Sponsor |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|