Trial Outcomes & Findings for Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH) (NCT NCT04267393)
NCT ID: NCT04267393
Last Updated: 2024-09-04
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
12 Weeks
Results posted on
2024-09-04
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
|
Treatment 1
BMS-986263 45mg QW
|
Treatment 2
BMS-986263 90mg QW
|
|---|---|---|---|
|
Randomization
STARTED
|
40
|
42
|
42
|
|
Randomization
COMPLETED
|
39
|
41
|
42
|
|
Randomization
NOT COMPLETED
|
1
|
1
|
0
|
|
Treatment Period
STARTED
|
39
|
41
|
42
|
|
Treatment Period
COMPLETED
|
36
|
35
|
35
|
|
Treatment Period
NOT COMPLETED
|
3
|
6
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
|
Treatment 1
BMS-986263 45mg QW
|
Treatment 2
BMS-986263 90mg QW
|
|---|---|---|---|
|
Randomization
Adverse Event
|
1
|
0
|
0
|
|
Randomization
Administrative Reasons by Sponsor
|
0
|
1
|
0
|
|
Treatment Period
Adverse Event
|
0
|
2
|
3
|
|
Treatment Period
Participant Withdrew Consent
|
0
|
0
|
1
|
|
Treatment Period
Administrative Reasons by Sponsor
|
3
|
4
|
3
|
Baseline Characteristics
Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
Baseline characteristics by cohort
| Measure |
Placebo
n=40 Participants
Placebo
|
Treatment 1
n=42 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Age, Continuous
|
58.9 Years
STANDARD_DEVIATION 8.56 • n=99 Participants
|
58.9 Years
STANDARD_DEVIATION 6.76 • n=107 Participants
|
60.0 Years
STANDARD_DEVIATION 8.65 • n=206 Participants
|
59.3 Years
STANDARD_DEVIATION 7.98 • n=7 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
72 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
52 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
97 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Modified Intent to Treat Population (mITT)
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).
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo
|
Treatment 1
n=41 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
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.
|
20.5 Percentage
|
12.2 Percentage
|
7.1 Percentage
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: mITT population
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).
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo
|
Treatment 1
n=41 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
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.
|
20.5 Percentage
|
12.2 Percentage
|
4.8 Percentage
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: mITT Population
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).
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo
|
Treatment 1
n=41 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
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.
|
2.6 Percentage
|
0 Percentage
|
0 Percentage
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: mITT Population
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
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo
|
Treatment 1
n=41 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥ 1 Stage Improvement in Liver Fibrosis (Modified Ishak Score) After 12 Weeks of Treatment.
|
30.8 Percentage
|
26.8 Percentage
|
21.4 Percentage
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: mITT Population
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
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo
|
Treatment 1
n=41 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
Percentage of Participants Who Achieve ≥ 2 Stage Improvement in Liver Fibrosis (Modified Ishak Score) After 12 Weeks of Treatment.
|
10.3 Percentage
|
4.9 Percentage
|
4.8 Percentage
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Total number of evaluable participants are those who have both baseline and Week 12/ETT biopsy available
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.
Outcome measures
| Measure |
Placebo
n=35 Participants
Placebo
|
Treatment 1
n=32 Participants
BMS-986263 45mg QW
|
Treatment 2
n=27 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
Mean Change From Baseline in CPA After 12 Weeks of Treatment
|
-3.67 Percentage
Standard Error 1.861
|
-0.35 Percentage
Standard Error 1.374
|
-3.67 Percentage
Standard Error 1.973
|
SECONDARY outcome
Timeframe: From First Treatment to end of Follow up (36 weeks)Population: All Treated Participants
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.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo
|
Treatment 1
n=41 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Events (TESAE)
TEAE
|
24 Participants
|
33 Participants
|
34 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Events (TESAE)
TESAE
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From First Treatment to end of Follow up (36 weeks)Population: All Treated Participants
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.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo
|
Treatment 1
n=41 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values.
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From First Treatment to end of Follow up (36 weeks)Population: All Treated Participants
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.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo
|
Treatment 1
n=41 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vitals Signs.
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From First Treatment to end of Follow up (36 weeks)Population: All Treated Participants
Physical examination includes body weight, height, and BMI (height and BMI calculation at screening only).
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo
|
Treatment 1
n=41 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Physical Examination Findings.
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From First Treatment to end of Follow up (36 weeks)Population: All Treated Participants
Number of Participants with clinically significant changes in electrocardiogram readings.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo
|
Treatment 1
n=41 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram Readings.
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From First Treatment to end of Follow up (36 weeks)Population: All Treated Participants
Bone Mineral Density(BMD) will be measured by a dual-energy X-ray absorptiometry (DXA) Scan.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo
|
Treatment 1
n=41 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in BMD.
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: All participants who receive at least 1 dose of BMS-986263 and have any available concentration-time data.
Plasma concentrations of BMS-986263 components: siRNA, DPD, HEDC, and S104.
Outcome measures
| Measure |
Placebo
Placebo
|
Treatment 1
n=42 Participants
BMS-986263 45mg QW
|
Treatment 2
n=42 Participants
BMS-986263 90mg QW
|
|---|---|---|---|
|
Plasma Concentration of BMS-986263 Components at the End of 12 Weeks or ETT.
siRNA
|
—
|
38.9 ng/mL
Geometric Coefficient of Variation 151
|
72.9 ng/mL
Geometric Coefficient of Variation 169
|
|
Plasma Concentration of BMS-986263 Components at the End of 12 Weeks or ETT.
DPD
|
—
|
519 ng/mL
Geometric Coefficient of Variation 45.2
|
1138 ng/mL
Geometric Coefficient of Variation 80.7
|
|
Plasma Concentration of BMS-986263 Components at the End of 12 Weeks or ETT.
HEDC
|
—
|
25.1 ng/mL
Geometric Coefficient of Variation 51.8
|
59.0 ng/mL
Geometric Coefficient of Variation 58.8
|
|
Plasma Concentration of BMS-986263 Components at the End of 12 Weeks or ETT.
S104
|
—
|
4.16 ng/mL
Geometric Coefficient of Variation 141
|
3.68 ng/mL
Geometric Coefficient of Variation 50.7
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Treatment 1
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Treatment 2
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=39 participants at risk
Placebo QW
|
Treatment 1
n=41 participants at risk
BMS-986263 45mg QW
|
Treatment 2
n=42 participants at risk
BMS-986263 90mg QW
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/39 • 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.
|
0.00%
0/41 • 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.
|
2.4%
1/42 • 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.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/39 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/42 • 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.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
2.6%
1/39 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/42 • 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.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/39 • 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.
|
0.00%
0/41 • 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.
|
2.4%
1/42 • 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.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/39 • 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.
|
0.00%
0/41 • 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.
|
2.4%
1/42 • 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.
|
Other adverse events
| Measure |
Placebo
n=39 participants at risk
Placebo QW
|
Treatment 1
n=41 participants at risk
BMS-986263 45mg QW
|
Treatment 2
n=42 participants at risk
BMS-986263 90mg QW
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.1%
2/39 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/42 • 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.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39 • 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.
|
4.9%
2/41 • 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.
|
2.4%
1/42 • 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.
|
|
General disorders
Asthenia
|
5.1%
2/39 • 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.
|
0.00%
0/41 • 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.
|
0.00%
0/42 • 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.
|
|
General disorders
Fatigue
|
5.1%
2/39 • 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.
|
2.4%
1/41 • 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.
|
9.5%
4/42 • 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.
|
|
Infections and infestations
COVID-19
|
10.3%
4/39 • 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.
|
9.8%
4/41 • 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.
|
2.4%
1/42 • 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.
|
|
Infections and infestations
Urinary tract infection
|
5.1%
2/39 • 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.
|
0.00%
0/41 • 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.
|
2.4%
1/42 • 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.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/39 • 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.
|
41.5%
17/41 • 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.
|
52.4%
22/42 • 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.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.1%
2/39 • 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.
|
0.00%
0/41 • 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.
|
2.4%
1/42 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
2/39 • 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.
|
4.9%
2/41 • 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.
|
4.8%
2/42 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • 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.
|
4.9%
2/41 • 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.
|
4.8%
2/42 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.7%
3/39 • 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.
|
2.4%
1/41 • 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.
|
2.4%
1/42 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
4/39 • 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.
|
2.4%
1/41 • 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.
|
0.00%
0/42 • 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.
|
|
Nervous system disorders
Headache
|
10.3%
4/39 • 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.
|
9.8%
4/41 • 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.
|
14.3%
6/42 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
2/39 • 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.
|
2.4%
1/41 • 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.
|
2.4%
1/42 • 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.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER