Trial Outcomes & Findings for A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis (NCT NCT05730725)
NCT ID: NCT05730725
Last Updated: 2025-11-25
Results Overview
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-75 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 75% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
12 Weeks
Results posted on
2025-11-25
Participant Flow
109 Participants Enrolled and Treated
Participant milestones
| Measure |
Placebo
Placebo
|
Treatment 1
BMS-986322 16mg
|
Treatment 2
BMS-986322 32mg
|
Treatment 3
BMS-986322 64mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
27
|
27
|
|
Overall Study
COMPLETED
|
24
|
26
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo
|
Treatment 1
BMS-986322 16mg
|
Treatment 2
BMS-986322 32mg
|
Treatment 3
BMS-986322 64mg
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
1
|
|
Overall Study
Not Reported
|
1
|
1
|
1
|
1
|
Baseline Characteristics
A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.1 Years
STANDARD_DEVIATION 10.77 • n=45 Participants
|
50.2 Years
STANDARD_DEVIATION 14.31 • n=12929 Participants
|
50.8 Years
STANDARD_DEVIATION 10.82 • n=6349 Participants
|
45.9 Years
STANDARD_DEVIATION 12.09 • n=4548 Participants
|
49.5 Years
STANDARD_DEVIATION 12.09 • n=28448 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=45 Participants
|
11 Participants
n=12929 Participants
|
9 Participants
n=6349 Participants
|
7 Participants
n=4548 Participants
|
35 Participants
n=28448 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=45 Participants
|
16 Participants
n=12929 Participants
|
18 Participants
n=6349 Participants
|
20 Participants
n=4548 Participants
|
74 Participants
n=28448 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=45 Participants
|
12 Participants
n=12929 Participants
|
8 Participants
n=6349 Participants
|
8 Participants
n=4548 Participants
|
39 Participants
n=28448 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=45 Participants
|
15 Participants
n=12929 Participants
|
18 Participants
n=6349 Participants
|
19 Participants
n=4548 Participants
|
68 Participants
n=28448 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
2 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
2 Participants
n=4548 Participants
|
6 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=45 Participants
|
7 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
6 Participants
n=4548 Participants
|
24 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
3 Participants
n=4548 Participants
|
5 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=45 Participants
|
18 Participants
n=12929 Participants
|
21 Participants
n=6349 Participants
|
16 Participants
n=4548 Participants
|
73 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
1 Participants
n=28448 Participants
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: Full Analysis Set
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-75 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 75% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Treatment 2
n=26 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=23 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Percentage of Participants Achiving PASI-75 at Week 12
|
80.8 Percentage
Interval 60.6 to 93.4
|
63.0 Percentage
Interval 42.4 to 80.6
|
3.6 Percentage
Interval 0.1 to 18.3
|
47.8 Percentage
Interval 26.8 to 69.4
|
PRIMARY outcome
Timeframe: approximately 85 daysPopulation: All Treated Participants
Treatment related adverse events, serious adverse events and treatment related adverse events leading to treatment discontinuation are considered safety related events.
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Number of Participants With Safety Related Events
TEAEs leading to discontinuation
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Safety Related Events
Any TEAE
|
14 Participants
|
16 Participants
|
16 Participants
|
14 Participants
|
|
Number of Participants With Safety Related Events
Any SAE
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: approximately 5 monthsPopulation: All Treated Participants
Mild TEAE: An event that is easily tolerated by the participant, causing minimal discomfort, and not interfering with everyday activities. Moderate TEAE:An event that causes sufficient discomfort and interferes with normal everyday activities. Severe TEAE: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event, and both AEs and SAEs can be assessed as severe.
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Number of Participants With TEAE by Worst Intensity
Mild
|
10 Participants
|
10 Participants
|
10 Participants
|
7 Participants
|
|
Number of Participants With TEAE by Worst Intensity
Moderate
|
4 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
|
Number of Participants With TEAE by Worst Intensity
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With TEAE by Worst Intensity
Not Reported
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: approximately 5 monthsPopulation: All Treated Participants
Number of participants with AE indicating clinical laboratory abnormality
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Number of Participants With AE Indicating Clinical Laboratory Abnormality
Blood creatine phosphokinase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With AE Indicating Clinical Laboratory Abnormality
Thrombocytopenia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With AE Indicating Clinical Laboratory Abnormality
Hyertransaminasaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With AE Indicating Clinical Laboratory Abnormality
Hypercholesterolaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With AE Indicating Clinical Laboratory Abnormality
Hypernatraemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With AE Indicating Clinical Laboratory Abnormality
Anaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With AE Indicating Clinical Laboratory Abnormality
Iron Deficiency Anaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: approximately 5 monthsPopulation: Safety Population
Number of participants with clinically significant changes from baseline in ECG evaluations. ECG results for participants with any result outside of a pre-specified range and investigator identified abnormalities will be listed for the Safety Population. The following criteria will be used to determine ECG results that are outside of a pre-specified range: * PR (msec): Value \> 200 * QRS (msec): Value \> 120 * QT (msec): Value \> 500 or change from baseline \> 30 * QTcF (msec): Value \> 450 or change from baseline \> 30
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: approximately 5 monthsPopulation: Safety Population
Number of participants with clinically significant changes from baseline in vital signs evaluations. Vital signs for participants with any out-of-range result will be listed for the Safety Population. The following criteria will be used to determine vital sign results that are outside of a prespecified range, where changes from baseline are based on matched postural positions: * Heart Rate (bpm): Value \> 100 and change from baseline \> 30, or Value \< 55 and change from baseline \< -15 * Systolic blood pressure (mmHg): Value \> 140 and change from baseline \> 20, or Value \< 90 and change from baseline \< -20 * Diastolic blood pressure (mmHg): Value \> 90 and change from baseline \> 10, or Value \< 55 and change from baseline \< -10 * Respiration (breaths/min): Value \> 16 or change from baseline \> 10 * Temperature (°C): Value \> 38.3 or change from baseline \> 1.6
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: approximately 5 monthsPopulation: All Treated Participants
Number of participants with clinically significant changes from baseline in physical examination evaluations
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Full Analysis Set
The static Physician's Global Assessment(sPGA) The sPGA is used to assess a participant's psoriasis lesions at a specific time point. Lesions are graded based on three characteristics: Erythema (E) Induration (I) Scaling (S) Each is scored individually, and the average of the three scores, rounded to the nearest whole number, determines the final sPGA score. 0 = No evidence 1= Minimal 2 = Mild 3 = Moderate 4 = Severe. The lower the score the better.
Outcome measures
| Measure |
Treatment 2
n=26 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=24 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12
|
69.2 Percentage
Interval 48.2 to 85.7
|
55.6 Percentage
Interval 35.3 to 74.5
|
3.6 Percentage
Interval 0.1 to 18.3
|
54.2 Percentage
Interval 2.8 to 74.4
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Full Analysis Set
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-50 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 50% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Treatment 2
n=26 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=23 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Percentage of Participants Achiving PASI-50 at Week 12
|
92.3 Percentage of Participants
Interval 74.9 to 99.1
|
81.5 Percentage of Participants
Interval 61.9 to 93.7
|
17.9 Percentage of Participants
Interval 6.1 to 36.9
|
73.9 Percentage of Participants
Interval 51.6 to 89.8
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Full Analysis Set
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-90 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 90% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Treatment 2
n=26 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=23 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Percentage of Participants Achiving PASI-90 at Week 12
|
61.5 Percentage of Participants
Interval 40.6 to 79.8
|
40.7 Percentage of Participants
Interval 22.4 to 61.2
|
3.6 Percentage of Participants
Interval 0.1 to 18.3
|
13.0 Percentage of Participants
Interval 2.8 to 33.6
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: Full Analysis Set
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-100 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 100% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Treatment 2
n=26 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=23 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Percentage of Participants Achiving PASI-100 at Week 12
|
15.4 Percentage of Participants
Interval 4.4 to 34.9
|
3.7 Percentage of Participants
Interval 0.1 to 19.0
|
0 Percentage of Participants
Interval 0.0 to 12.3
|
0 Percentage of Participants
Interval 0.0 to 14.8
|
SECONDARY outcome
Timeframe: From start of treatment (Week 1) to Week 2, 4, 8 and 12Population: Full Analysis Set
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-75 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 75% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Change of PASI-75 Scores Overtime
Week 1
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
3.8 Percentage of Participants
Interval 0.1 to 19.6
|
0.0 Percentage of Participants
Interval 0.0 to 13.7
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
|
Change of PASI-75 Scores Overtime
Week 2
|
11.5 Percentage of Participants
Interval 2.4 to 30.2
|
4.0 Percentage of Participants
Interval 0.1 to 20.4
|
0.0 Percentage of Participants
Interval 0.0 to 13.7
|
0.0 Percentage of Participants
Interval 0.0 to 12.8
|
|
Change of PASI-75 Scores Overtime
Week 4
|
33.3 Percentage of Participants
Interval 16.5 to 54.0
|
30.8 Percentage of Participants
Interval 14.3 to 51.8
|
3.6 Percentage of Participants
Interval 0.1 to 18.3
|
7.4 Percentage of Participants
Interval 0.9 to 24.3
|
|
Change of PASI-75 Scores Overtime
Week 8
|
66.7 Percentage of Participants
Interval 46.0 to 83.5
|
57.7 Percentage of Participants
Interval 36.9 to 76.6
|
4.0 Percentage of Participants
Interval 0.1 to 20.4
|
40.0 Percentage of Participants
Interval 21.1 to 61.3
|
|
Change of PASI-75 Scores Overtime
Week 12
|
80.8 Percentage of Participants
Interval 60.6 to 93.4
|
72.0 Percentage of Participants
Interval 50.6 to 87.9
|
4.2 Percentage of Participants
Interval 0.1 to 21.1
|
54.5 Percentage of Participants
Interval 32.2 to 75.6
|
SECONDARY outcome
Timeframe: From start of treatment (Week 1) to Week 2, 4, 8 and 12Population: Full Analysis Set
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-90 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 90% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Change of PASI-90 Scores Overtime
Week 1
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
0.0 Percentage of Participants
Interval 0.0 to 13.7
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
|
Change of PASI-90 Scores Overtime
Week 2
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
0.0 Percentage of Participants
Interval 0.0 to 13.7
|
0.0 Percentage of Participants
Interval 0.0 to 13.7
|
0.0 Percentage of Participants
Interval 0.0 to 12.8
|
|
Change of PASI-90 Scores Overtime
Week 4
|
18.5 Percentage of Participants
Interval 6.3 to 38.1
|
7.7 Percentage of Participants
Interval 0.9 to 25.1
|
0.0 Percentage of Participants
Interval 0.0 to 12.3
|
0.0 Percentage of Participants
Interval 0.0 to 12.8
|
|
Change of PASI-90 Scores Overtime
Week 8
|
25.9 Percentage of Participants
Interval 11.1 to 46.3
|
30.8 Percentage of Participants
Interval 14.3 to 51.8
|
4.0 Percentage of Participants
Interval 0.1 to 20.4
|
8.0 Percentage of Participants
Interval 1.0 to 26.0
|
|
Change of PASI-90 Scores Overtime
Week 12
|
61.5 Percentage of Participants
Interval 40.6 to 79.8
|
48.0 Percentage of Participants
Interval 27.8 to 68.7
|
4.2 Percentage of Participants
Interval 0.1 to 21.1
|
13.6 Percentage of Participants
Interval 2.9 to 34.9
|
SECONDARY outcome
Timeframe: From start of treatment (Week 1) to Week 2, 4, 8 and 12Population: Full Analysis Set
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-100 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 100% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Change of PASI-100 Scores Overtime
Week 1
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
0.0 Percentage of Participants
Interval 0.0 to 13.7
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
|
Change of PASI-100 Scores Overtime
Week 2
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
0.0 Percentage of Participants
Interval 0.0 to 13.7
|
0.0 Percentage of Participants
Interval 0.0 to 13.7
|
0.0 Percentage of Participants
Interval 0.0 to 12.8
|
|
Change of PASI-100 Scores Overtime
Week 4
|
3.7 Percentage of Participants
Interval 0.1 to 19.0
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
0.0 Percentage of Participants
Interval 0.0 to 12.3
|
0.0 Percentage of Participants
Interval 0.0 to 12.8
|
|
Change of PASI-100 Scores Overtime
Week 8
|
3.7 Percentage of Participants
Interval 0.1 to 19.0
|
0.0 Percentage of Participants
Interval 0.0 to 13.2
|
0.0 Percentage of Participants
Interval 0.0 to 13.7
|
0.0 Percentage of Participants
Interval 0.0 to 13.7
|
|
Change of PASI-100 Scores Overtime
Week 12
|
15.4 Percentage of Participants
Interval 4.4 to 34.9
|
4.0 Percentage of Participants
Interval 0.1 to 20.4
|
0.0 Percentage of Participants
Interval 0.0 to 14.2
|
0.0 Percentage of Participants
Interval 0.0 to 15.4
|
SECONDARY outcome
Timeframe: From start of treatment (Week 1) to Week 2, 4, 8 and 12Population: Full Analysis Set
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-50 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 50% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Change of PASI-50 Scores Overtime
Week 1
|
7.7 Percentage of Participants
Interval 0.9 to 25.1
|
7.7 Percentage of Participants
Interval 0.9 to 25.1
|
0.0 Percentage of Participants
Interval 0.0 to 13.7
|
3.8 Percentage of Participants
Interval 0.1 to 19.6
|
|
Change of PASI-50 Scores Overtime
Week 2
|
34.6 Percentage of Participants
Interval 17.2 to 55.7
|
24.0 Percentage of Participants
Interval 9.4 to 45.1
|
12.0 Percentage of Participants
Interval 2.5 to 31.2
|
14.8 Percentage of Participants
Interval 4.2 to 33.7
|
|
Change of PASI-50 Scores Overtime
Week 4
|
66.7 Percentage of Participants
Interval 46.0 to 83.5
|
65.4 Percentage of Participants
Interval 44.3 to 82.8
|
10.7 Percentage of Participants
Interval 2.3 to 28.2
|
48.1 Percentage of Participants
Interval 28.7 to 68.1
|
|
Change of PASI-50 Scores Overtime
Week 8
|
85.2 Percentage of Participants
Interval 66.3 to 95.8
|
88.5 Percentage of Participants
Interval 69.8 to 97.6
|
8.0 Percentage of Participants
Interval 1.0 to 26.0
|
84.0 Percentage of Participants
Interval 63.9 to 95.5
|
|
Change of PASI-50 Scores Overtime
Week 12
|
92.3 Percentage of Participants
Interval 74.9 to 99.1
|
92.0 Percentage of Participants
Interval 74.0 to 99.0
|
20.8 Percentage of Participants
Interval 7.1 to 42.2
|
81.8 Percentage of Participants
Interval 59.7 to 94.8
|
SECONDARY outcome
Timeframe: From start of treatment (Week 1) to Week 2, 4, 8, and 12Population: Full Analysis Set
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
n=27 Participants
BMS-986322 64mg
|
Placebo
n=28 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Mean Change Frome Baseline of PASI Scores Overtime
Week 2
|
-7.13 PASI Score on a Scale
Standard Deviation 6.699
|
-6.27 PASI Score on a Scale
Standard Deviation 5.421
|
-3.30 PASI Score on a Scale
Standard Deviation 5.803
|
-5.16 PASI Score on a Scale
Standard Deviation 4.856
|
|
Mean Change Frome Baseline of PASI Scores Overtime
Week 4
|
-10.63 PASI Score on a Scale
Standard Deviation 7.512
|
-10.05 PASI Score on a Scale
Standard Deviation 6.629
|
-3.97 PASI Score on a Scale
Standard Deviation 7.872
|
-8.53 PASI Score on a Scale
Standard Deviation 6.311
|
|
Mean Change Frome Baseline of PASI Scores Overtime
Week 8
|
-13.66 PASI Score on a Scale
Standard Deviation 8.265
|
-14.06 PASI Score on a Scale
Standard Deviation 6.452
|
-3.73 PASI Score on a Scale
Standard Deviation 7.521
|
-13.34 PASI Score on a Scale
Standard Deviation 5.734
|
|
Mean Change Frome Baseline of PASI Scores Overtime
Week 1
|
-2.95 PASI Score on a Scale
Standard Deviation 4.525
|
-3.36 PASI Score on a Scale
Standard Deviation 4.047
|
-0.50 PASI Score on a Scale
Standard Deviation 5.765
|
-2.85 PASI Score on a Scale
Standard Deviation 3.782
|
|
Mean Change Frome Baseline of PASI Scores Overtime
Week 12
|
-15.39 PASI Score on a Scale
Standard Deviation 8.971
|
-15.44 PASI Score on a Scale
Standard Deviation 6.429
|
-4.43 PASI Score on a Scale
Standard Deviation 8.030
|
-14.55 PASI Score on a Scale
Standard Deviation 6.644
|
SECONDARY outcome
Timeframe: From start of treatment (Week 1) to Week 2, 4, 8 and 12Population: All participants who were treated with BMS-986322 and with PK measurements
trough observed plasma concentration
Outcome measures
| Measure |
Treatment 2
n=27 Participants
BMS-986322 32mg
|
Treatment 3
BMS-986322 64mg
|
Placebo
n=27 Participants
Placebo
|
Treatment 1
n=27 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Ctrough Measurements Overtime
Week 1
|
138.950 ng/mL
Geometric Coefficient of Variation 735.3
|
—
|
55.463 ng/mL
Geometric Coefficient of Variation 83.8
|
128.971 ng/mL
Geometric Coefficient of Variation 121.6
|
|
Ctrough Measurements Overtime
Week 2
|
191.509 ng/mL
Geometric Coefficient of Variation 349.3
|
—
|
57.595 ng/mL
Geometric Coefficient of Variation 97.7
|
99.871 ng/mL
Geometric Coefficient of Variation 273.3
|
|
Ctrough Measurements Overtime
Week 4
|
153.285 ng/mL
Geometric Coefficient of Variation 618.6
|
—
|
57.728 ng/mL
Geometric Coefficient of Variation 73.7
|
111.379 ng/mL
Geometric Coefficient of Variation 235.3
|
|
Ctrough Measurements Overtime
Week 8
|
112.852 ng/mL
Geometric Coefficient of Variation 1125.2
|
—
|
42.370 ng/mL
Geometric Coefficient of Variation 224.9
|
68.035 ng/mL
Geometric Coefficient of Variation 479.9
|
|
Ctrough Measurements Overtime
Week 12
|
82.047 ng/mL
Geometric Coefficient of Variation 3201.7
|
—
|
47.321 ng/mL
Geometric Coefficient of Variation 235.6
|
52.295 ng/mL
Geometric Coefficient of Variation 534.0
|
SECONDARY outcome
Timeframe: At Day 15 post first dosePopulation: All participants who were treated with BMS-986322 and with Cmax measurements
maximum observed concentration
Outcome measures
| Measure |
Treatment 2
n=23 Participants
BMS-986322 32mg
|
Treatment 3
BMS-986322 64mg
|
Placebo
n=25 Participants
Placebo
|
Treatment 1
n=24 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Cmax at Day 15
|
871.064 ng/mL
Geometric Coefficient of Variation 34.9
|
—
|
210.410 ng/mL
Geometric Coefficient of Variation 36.1
|
411.027 ng/mL
Geometric Coefficient of Variation 41.9
|
SECONDARY outcome
Timeframe: At Day 15 post first dosePopulation: All participants who were treated with BMS-986322 and with Tmax measurements
time to maximum observed concentration
Outcome measures
| Measure |
Treatment 2
n=23 Participants
BMS-986322 32mg
|
Treatment 3
BMS-986322 64mg
|
Placebo
n=25 Participants
Placebo
|
Treatment 1
n=24 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
Tmax at Day 15
|
2.000 hours
Interval 0.917 to 4.75
|
—
|
1.0830 hours
Interval 0.5 to 5.0
|
1.0415 hours
Interval 0.0 to 5.05
|
SECONDARY outcome
Timeframe: At Day 15 post first dosePopulation: All participants who were treated with BMS-986322 and with AUC(Tau) measurements
area under the plasma concentration-time curve over the dosing interval
Outcome measures
| Measure |
Treatment 2
n=22 Participants
BMS-986322 32mg
|
Treatment 3
BMS-986322 64mg
|
Placebo
n=25 Participants
Placebo
|
Treatment 1
n=24 Participants
BMS-986322 16mg
|
|---|---|---|---|---|
|
AUC(Tau) at Day 15
|
11815.731 h*ng/mL
Geometric Coefficient of Variation 37.1
|
—
|
2576.824 h*ng/mL
Geometric Coefficient of Variation 49.3
|
5057.790 h*ng/mL
Geometric Coefficient of Variation 53.2
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment 1
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Treatment 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Treatment 3
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=28 participants at risk
Placebo
|
Treatment 1
n=27 participants at risk
BMS-986322 16 mg
|
Treatment 2
n=27 participants at risk
BMS-986322 32 mg
|
Treatment 3
n=27 participants at risk
BMS-986322 64 mg
|
|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
3.6%
1/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
3.7%
1/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Placebo
|
Treatment 1
n=27 participants at risk
BMS-986322 16 mg
|
Treatment 2
n=27 participants at risk
BMS-986322 32 mg
|
Treatment 3
n=27 participants at risk
BMS-986322 64 mg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
7.4%
2/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
3.7%
1/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
3.7%
1/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
11.1%
3/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Infections and infestations
COVID-19
|
0.00%
0/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
3.7%
1/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
11.1%
3/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Infections and infestations
Folliculitis
|
0.00%
0/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
11.1%
3/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Infections and infestations
Herpes zoster
|
7.1%
2/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Infections and infestations
Influenza
|
3.6%
1/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
7.4%
2/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
3.7%
1/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
7.4%
2/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
3.7%
1/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
7.4%
2/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
3.7%
1/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
7.4%
2/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
3.7%
1/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
7.4%
2/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Nervous system disorders
Headache
|
0.00%
0/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
7.4%
2/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
3.7%
1/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
14.8%
4/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
7.4%
2/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
14.3%
4/28 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
3.7%
1/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
0.00%
0/27 • Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
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
|
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