Psoriasis
Conditions
Keywords
Moderate-to-Severe Psoriasis, BMS-986322, TYK2 inhibitor
Brief summary
The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.
Interventions
DRUGBMS-986322
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of plaque psoriasis (PsO) for ≥ 6 months * Body mass index 18 to 40 kg/m\^2 and total body weight \> 50 kg (110 lbs) * Deemed by Investigator to be eligible for phototherapy or systemic therapy * Psoriatic plaques must cover ≥ 10% of body surface area at baseline * Psoriasis Area and Severity Index (PASI) score ≥ 12 and static Physician Global Assessment (sPGA) ≥ 3 at baseline
Exclusion criteria
* Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic) * Diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with PsO for which a participant requires current systemic immunosuppressant medical treatment * Any significant acute or chronic medical illness Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achiving PASI-75 at Week 12 | 12 Weeks | 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. |
| Number of Participants With Safety Related Events | approximately 85 days | Treatment related adverse events, serious adverse events and treatment related adverse events leading to treatment discontinuation are considered safety related events. |
| Number of Participants With TEAE by Worst Intensity | approximately 5 months | 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. |
| Number of Participants With AE Indicating Clinical Laboratory Abnormality | approximately 5 months | Number of participants with AE indicating clinical laboratory abnormality |
| Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations. | approximately 5 months | 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 |
| Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations | approximately 5 months | 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 |
| Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations | approximately 5 months | Number of participants with clinically significant changes from baseline in physical examination evaluations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of PASI-50 Scores Overtime | From start of treatment (Week 1) to Week 2, 4, 8 and 12 | 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. |
| Mean Change Frome Baseline of PASI Scores Overtime | From start of treatment (Week 1) to Week 2, 4, 8, and 12 | 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. |
| Ctrough Measurements Overtime | From start of treatment (Week 1) to Week 2, 4, 8 and 12 | trough observed plasma concentration |
| Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12 | 12 Weeks | 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. |
| Tmax at Day 15 | At Day 15 post first dose | time to maximum observed concentration |
| AUC(Tau) at Day 15 | At Day 15 post first dose | area under the plasma concentration-time curve over the dosing interval |
| Cmax at Day 15 | At Day 15 post first dose | maximum observed concentration |
| Percentage of Participants Achiving PASI-50 at Week 12 | 12 Weeks | 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. |
| Percentage of Participants Achiving PASI-90 at Week 12 | 12 Weeks | 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. |
| Percentage of Participants Achiving PASI-100 at Week 12 | 12 Weeks | 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. |
| Change of PASI-75 Scores Overtime | From start of treatment (Week 1) to Week 2, 4, 8 and 12 | 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. |
| Change of PASI-90 Scores Overtime | From start of treatment (Week 1) to Week 2, 4, 8 and 12 | 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. |
| Change of PASI-100 Scores Overtime | From start of treatment (Week 1) to Week 2, 4, 8 and 12 | 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. |
Countries
Australia, Canada, Japan, United Kingdom, United States
Participant flow
Pre-assignment details
109 Participants Enrolled and Treated
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo | 28 |
| Treatment 1 BMS-986322 16mg | 27 |
| Treatment 2 BMS-986322 32mg | 27 |
| Treatment 3 BMS-986322 64mg | 27 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Not Reported | 1 | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Treatment 1 | Treatment 2 | Treatment 3 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51.1 Years STANDARD_DEVIATION 10.77 | 50.2 Years STANDARD_DEVIATION 14.31 | 50.8 Years STANDARD_DEVIATION 10.82 | 45.9 Years STANDARD_DEVIATION 12.09 | 49.5 Years STANDARD_DEVIATION 12.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 12 Participants | 8 Participants | 8 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 15 Participants | 18 Participants | 19 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 7 Participants | 4 Participants | 6 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 18 Participants | 21 Participants | 16 Participants | 73 Participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 9 Participants | 7 Participants | 35 Participants |
| Sex: Female, Male Male | 20 Participants | 16 Participants | 18 Participants | 20 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 27 | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 7 / 28 | 7 / 27 | 10 / 27 | 11 / 27 |
| serious Total, serious adverse events | 1 / 28 | 1 / 27 | 0 / 27 | 0 / 27 |
Outcome results
Primary
Number of Participants With AE Indicating Clinical Laboratory Abnormality
Number of participants with AE indicating clinical laboratory abnormality
Time frame: approximately 5 months
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Thrombocytopenia | 0 Participants |
| Placebo | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Blood creatine phosphokinase increased | 0 Participants |
| Placebo | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hypernatraemia | 0 Participants |
| Placebo | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hypercholesterolaemia | 0 Participants |
| Placebo | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hyertransaminasaemia | 0 Participants |
| Placebo | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Iron Deficiency Anaemia | 0 Participants |
| Placebo | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Anaemia | 0 Participants |
| Treatment 1 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Iron Deficiency Anaemia | 0 Participants |
| Treatment 1 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Thrombocytopenia | 0 Participants |
| Treatment 1 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Blood creatine phosphokinase increased | 1 Participants |
| Treatment 1 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hypernatraemia | 0 Participants |
| Treatment 1 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hypercholesterolaemia | 0 Participants |
| Treatment 1 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Anaemia | 0 Participants |
| Treatment 1 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hyertransaminasaemia | 0 Participants |
| Treatment 2 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Iron Deficiency Anaemia | 0 Participants |
| Treatment 2 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hypercholesterolaemia | 1 Participants |
| Treatment 2 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hypernatraemia | 0 Participants |
| Treatment 2 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Anaemia | 0 Participants |
| Treatment 2 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Thrombocytopenia | 0 Participants |
| Treatment 2 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hyertransaminasaemia | 0 Participants |
| Treatment 2 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Blood creatine phosphokinase increased | 0 Participants |
| Treatment 3 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Anaemia | 1 Participants |
| Treatment 3 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Blood creatine phosphokinase increased | 0 Participants |
| Treatment 3 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hyertransaminasaemia | 1 Participants |
| Treatment 3 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hypernatraemia | 1 Participants |
| Treatment 3 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Hypercholesterolaemia | 0 Participants |
| Treatment 3 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Thrombocytopenia | 1 Participants |
| Treatment 3 | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Iron Deficiency Anaemia | 1 Participants |
Primary
Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations.
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
Time frame: approximately 5 months
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations. | 0 Participants |
| Treatment 1 | Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations. | 0 Participants |
| Treatment 2 | Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations. | 0 Participants |
| Treatment 3 | Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations. | 0 Participants |
Primary
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations
Number of participants with clinically significant changes from baseline in physical examination evaluations
Time frame: approximately 5 months
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations | 0 Participants |
| Treatment 1 | Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations | 0 Participants |
| Treatment 2 | Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations | 0 Participants |
| Treatment 3 | Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations | 0 Participants |
Primary
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations
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
Time frame: approximately 5 months
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations | 0 Participants |
| Treatment 1 | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations | 0 Participants |
| Treatment 2 | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations | 0 Participants |
| Treatment 3 | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations | 0 Participants |
Primary
Number of Participants With Safety Related Events
Treatment related adverse events, serious adverse events and treatment related adverse events leading to treatment discontinuation are considered safety related events.
Time frame: approximately 85 days
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Safety Related Events | Any TEAE | 16 Participants |
| Placebo | Number of Participants With Safety Related Events | TEAEs leading to discontinuation | 2 Participants |
| Placebo | Number of Participants With Safety Related Events | Any SAE | 1 Participants |
| Treatment 1 | Number of Participants With Safety Related Events | Any TEAE | 14 Participants |
| Treatment 1 | Number of Participants With Safety Related Events | TEAEs leading to discontinuation | 0 Participants |
| Treatment 1 | Number of Participants With Safety Related Events | Any SAE | 1 Participants |
| Treatment 2 | Number of Participants With Safety Related Events | Any SAE | 0 Participants |
| Treatment 2 | Number of Participants With Safety Related Events | Any TEAE | 14 Participants |
| Treatment 2 | Number of Participants With Safety Related Events | TEAEs leading to discontinuation | 0 Participants |
| Treatment 3 | Number of Participants With Safety Related Events | Any TEAE | 16 Participants |
| Treatment 3 | Number of Participants With Safety Related Events | TEAEs leading to discontinuation | 1 Participants |
| Treatment 3 | Number of Participants With Safety Related Events | Any SAE | 0 Participants |
Primary
Number of Participants With TEAE by Worst Intensity
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.
Time frame: approximately 5 months
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With TEAE by Worst Intensity | Mild | 10 Participants |
| Placebo | Number of Participants With TEAE by Worst Intensity | Moderate | 6 Participants |
| Placebo | Number of Participants With TEAE by Worst Intensity | Severe | 0 Participants |
| Placebo | Number of Participants With TEAE by Worst Intensity | Not Reported | 0 Participants |
| Treatment 1 | Number of Participants With TEAE by Worst Intensity | Moderate | 7 Participants |
| Treatment 1 | Number of Participants With TEAE by Worst Intensity | Severe | 0 Participants |
| Treatment 1 | Number of Participants With TEAE by Worst Intensity | Not Reported | 0 Participants |
| Treatment 1 | Number of Participants With TEAE by Worst Intensity | Mild | 7 Participants |
| Treatment 2 | Number of Participants With TEAE by Worst Intensity | Severe | 0 Participants |
| Treatment 2 | Number of Participants With TEAE by Worst Intensity | Moderate | 4 Participants |
| Treatment 2 | Number of Participants With TEAE by Worst Intensity | Not Reported | 0 Participants |
| Treatment 2 | Number of Participants With TEAE by Worst Intensity | Mild | 10 Participants |
| Treatment 3 | Number of Participants With TEAE by Worst Intensity | Not Reported | 0 Participants |
| Treatment 3 | Number of Participants With TEAE by Worst Intensity | Moderate | 6 Participants |
| Treatment 3 | Number of Participants With TEAE by Worst Intensity | Mild | 10 Participants |
| Treatment 3 | Number of Participants With TEAE by Worst Intensity | Severe | 0 Participants |
Primary
Percentage of Participants Achiving PASI-75 at Week 12
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.
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achiving PASI-75 at Week 12 | 3.6 Percentage |
| Treatment 1 | Percentage of Participants Achiving PASI-75 at Week 12 | 47.8 Percentage |
| Treatment 2 | Percentage of Participants Achiving PASI-75 at Week 12 | 80.8 Percentage |
| Treatment 3 | Percentage of Participants Achiving PASI-75 at Week 12 | 63.0 Percentage |
Secondary
AUC(Tau) at Day 15
area under the plasma concentration-time curve over the dosing interval
Time frame: At Day 15 post first dose
Population: All participants who were treated with BMS-986322 and with AUC(Tau) measurements
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | AUC(Tau) at Day 15 | 2576.824 h*ng/mL | Geometric Coefficient of Variation 49.3 |
| Treatment 1 | AUC(Tau) at Day 15 | 5057.790 h*ng/mL | Geometric Coefficient of Variation 53.2 |
| Treatment 2 | AUC(Tau) at Day 15 | 11815.731 h*ng/mL | Geometric Coefficient of Variation 37.1 |
Secondary
Change of PASI-100 Scores Overtime
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.
Time frame: From start of treatment (Week 1) to Week 2, 4, 8 and 12
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change of PASI-100 Scores Overtime | Week 12 | 0.0 Percentage of Participants |
| Placebo | Change of PASI-100 Scores Overtime | Week 8 | 0.0 Percentage of Participants |
| Placebo | Change of PASI-100 Scores Overtime | Week 4 | 0.0 Percentage of Participants |
| Placebo | Change of PASI-100 Scores Overtime | Week 2 | 0.0 Percentage of Participants |
| Placebo | Change of PASI-100 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
| Treatment 1 | Change of PASI-100 Scores Overtime | Week 8 | 0.0 Percentage of Participants |
| Treatment 1 | Change of PASI-100 Scores Overtime | Week 12 | 0.0 Percentage of Participants |
| Treatment 1 | Change of PASI-100 Scores Overtime | Week 2 | 0.0 Percentage of Participants |
| Treatment 1 | Change of PASI-100 Scores Overtime | Week 4 | 0.0 Percentage of Participants |
| Treatment 1 | Change of PASI-100 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
| Treatment 2 | Change of PASI-100 Scores Overtime | Week 8 | 3.7 Percentage of Participants |
| Treatment 2 | Change of PASI-100 Scores Overtime | Week 2 | 0.0 Percentage of Participants |
| Treatment 2 | Change of PASI-100 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
| Treatment 2 | Change of PASI-100 Scores Overtime | Week 4 | 3.7 Percentage of Participants |
| Treatment 2 | Change of PASI-100 Scores Overtime | Week 12 | 15.4 Percentage of Participants |
| Treatment 3 | Change of PASI-100 Scores Overtime | Week 12 | 4.0 Percentage of Participants |
| Treatment 3 | Change of PASI-100 Scores Overtime | Week 4 | 0.0 Percentage of Participants |
| Treatment 3 | Change of PASI-100 Scores Overtime | Week 8 | 0.0 Percentage of Participants |
| Treatment 3 | Change of PASI-100 Scores Overtime | Week 2 | 0.0 Percentage of Participants |
| Treatment 3 | Change of PASI-100 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
Secondary
Change of PASI-50 Scores Overtime
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.
Time frame: From start of treatment (Week 1) to Week 2, 4, 8 and 12
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change of PASI-50 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
| Placebo | Change of PASI-50 Scores Overtime | Week 4 | 10.7 Percentage of Participants |
| Placebo | Change of PASI-50 Scores Overtime | Week 8 | 8.0 Percentage of Participants |
| Placebo | Change of PASI-50 Scores Overtime | Week 12 | 20.8 Percentage of Participants |
| Placebo | Change of PASI-50 Scores Overtime | Week 2 | 12.0 Percentage of Participants |
| Treatment 1 | Change of PASI-50 Scores Overtime | Week 12 | 81.8 Percentage of Participants |
| Treatment 1 | Change of PASI-50 Scores Overtime | Week 8 | 84.0 Percentage of Participants |
| Treatment 1 | Change of PASI-50 Scores Overtime | Week 4 | 48.1 Percentage of Participants |
| Treatment 1 | Change of PASI-50 Scores Overtime | Week 1 | 3.8 Percentage of Participants |
| Treatment 1 | Change of PASI-50 Scores Overtime | Week 2 | 14.8 Percentage of Participants |
| Treatment 2 | Change of PASI-50 Scores Overtime | Week 2 | 34.6 Percentage of Participants |
| Treatment 2 | Change of PASI-50 Scores Overtime | Week 4 | 66.7 Percentage of Participants |
| Treatment 2 | Change of PASI-50 Scores Overtime | Week 8 | 85.2 Percentage of Participants |
| Treatment 2 | Change of PASI-50 Scores Overtime | Week 12 | 92.3 Percentage of Participants |
| Treatment 2 | Change of PASI-50 Scores Overtime | Week 1 | 7.7 Percentage of Participants |
| Treatment 3 | Change of PASI-50 Scores Overtime | Week 12 | 92.0 Percentage of Participants |
| Treatment 3 | Change of PASI-50 Scores Overtime | Week 2 | 24.0 Percentage of Participants |
| Treatment 3 | Change of PASI-50 Scores Overtime | Week 1 | 7.7 Percentage of Participants |
| Treatment 3 | Change of PASI-50 Scores Overtime | Week 8 | 88.5 Percentage of Participants |
| Treatment 3 | Change of PASI-50 Scores Overtime | Week 4 | 65.4 Percentage of Participants |
Secondary
Change of PASI-75 Scores Overtime
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.
Time frame: From start of treatment (Week 1) to Week 2, 4, 8 and 12
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change of PASI-75 Scores Overtime | Week 2 | 0.0 Percentage of Participants |
| Placebo | Change of PASI-75 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
| Placebo | Change of PASI-75 Scores Overtime | Week 4 | 3.6 Percentage of Participants |
| Placebo | Change of PASI-75 Scores Overtime | Week 12 | 4.2 Percentage of Participants |
| Placebo | Change of PASI-75 Scores Overtime | Week 8 | 4.0 Percentage of Participants |
| Treatment 1 | Change of PASI-75 Scores Overtime | Week 8 | 40.0 Percentage of Participants |
| Treatment 1 | Change of PASI-75 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
| Treatment 1 | Change of PASI-75 Scores Overtime | Week 2 | 0.0 Percentage of Participants |
| Treatment 1 | Change of PASI-75 Scores Overtime | Week 4 | 7.4 Percentage of Participants |
| Treatment 1 | Change of PASI-75 Scores Overtime | Week 12 | 54.5 Percentage of Participants |
| Treatment 2 | Change of PASI-75 Scores Overtime | Week 12 | 80.8 Percentage of Participants |
| Treatment 2 | Change of PASI-75 Scores Overtime | Week 4 | 33.3 Percentage of Participants |
| Treatment 2 | Change of PASI-75 Scores Overtime | Week 8 | 66.7 Percentage of Participants |
| Treatment 2 | Change of PASI-75 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
| Treatment 2 | Change of PASI-75 Scores Overtime | Week 2 | 11.5 Percentage of Participants |
| Treatment 3 | Change of PASI-75 Scores Overtime | Week 8 | 57.7 Percentage of Participants |
| Treatment 3 | Change of PASI-75 Scores Overtime | Week 2 | 4.0 Percentage of Participants |
| Treatment 3 | Change of PASI-75 Scores Overtime | Week 4 | 30.8 Percentage of Participants |
| Treatment 3 | Change of PASI-75 Scores Overtime | Week 1 | 3.8 Percentage of Participants |
| Treatment 3 | Change of PASI-75 Scores Overtime | Week 12 | 72.0 Percentage of Participants |
Secondary
Change of PASI-90 Scores Overtime
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.
Time frame: From start of treatment (Week 1) to Week 2, 4, 8 and 12
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Change of PASI-90 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
| Placebo | Change of PASI-90 Scores Overtime | Week 2 | 0.0 Percentage of Participants |
| Placebo | Change of PASI-90 Scores Overtime | Week 4 | 0.0 Percentage of Participants |
| Placebo | Change of PASI-90 Scores Overtime | Week 8 | 4.0 Percentage of Participants |
| Placebo | Change of PASI-90 Scores Overtime | Week 12 | 4.2 Percentage of Participants |
| Treatment 1 | Change of PASI-90 Scores Overtime | Week 12 | 13.6 Percentage of Participants |
| Treatment 1 | Change of PASI-90 Scores Overtime | Week 2 | 0.0 Percentage of Participants |
| Treatment 1 | Change of PASI-90 Scores Overtime | Week 8 | 8.0 Percentage of Participants |
| Treatment 1 | Change of PASI-90 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
| Treatment 1 | Change of PASI-90 Scores Overtime | Week 4 | 0.0 Percentage of Participants |
| Treatment 2 | Change of PASI-90 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
| Treatment 2 | Change of PASI-90 Scores Overtime | Week 2 | 0.0 Percentage of Participants |
| Treatment 2 | Change of PASI-90 Scores Overtime | Week 4 | 18.5 Percentage of Participants |
| Treatment 2 | Change of PASI-90 Scores Overtime | Week 12 | 61.5 Percentage of Participants |
| Treatment 2 | Change of PASI-90 Scores Overtime | Week 8 | 25.9 Percentage of Participants |
| Treatment 3 | Change of PASI-90 Scores Overtime | Week 8 | 30.8 Percentage of Participants |
| Treatment 3 | Change of PASI-90 Scores Overtime | Week 1 | 0.0 Percentage of Participants |
| Treatment 3 | Change of PASI-90 Scores Overtime | Week 2 | 0.0 Percentage of Participants |
| Treatment 3 | Change of PASI-90 Scores Overtime | Week 12 | 48.0 Percentage of Participants |
| Treatment 3 | Change of PASI-90 Scores Overtime | Week 4 | 7.7 Percentage of Participants |
Secondary
Cmax at Day 15
maximum observed concentration
Time frame: At Day 15 post first dose
Population: All participants who were treated with BMS-986322 and with Cmax measurements
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Cmax at Day 15 | 210.410 ng/mL | Geometric Coefficient of Variation 36.1 |
| Treatment 1 | Cmax at Day 15 | 411.027 ng/mL | Geometric Coefficient of Variation 41.9 |
| Treatment 2 | Cmax at Day 15 | 871.064 ng/mL | Geometric Coefficient of Variation 34.9 |
Secondary
Ctrough Measurements Overtime
trough observed plasma concentration
Time frame: From start of treatment (Week 1) to Week 2, 4, 8 and 12
Population: All participants who were treated with BMS-986322 and with PK measurements
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Ctrough Measurements Overtime | Week 2 | 57.595 ng/mL | Geometric Coefficient of Variation 97.7 |
| Placebo | Ctrough Measurements Overtime | Week 1 | 55.463 ng/mL | Geometric Coefficient of Variation 83.8 |
| Placebo | Ctrough Measurements Overtime | Week 12 | 47.321 ng/mL | Geometric Coefficient of Variation 235.6 |
| Placebo | Ctrough Measurements Overtime | Week 4 | 57.728 ng/mL | Geometric Coefficient of Variation 73.7 |
| Placebo | Ctrough Measurements Overtime | Week 8 | 42.370 ng/mL | Geometric Coefficient of Variation 224.9 |
| Treatment 1 | Ctrough Measurements Overtime | Week 1 | 128.971 ng/mL | Geometric Coefficient of Variation 121.6 |
| Treatment 1 | Ctrough Measurements Overtime | Week 2 | 99.871 ng/mL | Geometric Coefficient of Variation 273.3 |
| Treatment 1 | Ctrough Measurements Overtime | Week 8 | 68.035 ng/mL | Geometric Coefficient of Variation 479.9 |
| Treatment 1 | Ctrough Measurements Overtime | Week 12 | 52.295 ng/mL | Geometric Coefficient of Variation 534 |
| Treatment 1 | Ctrough Measurements Overtime | Week 4 | 111.379 ng/mL | Geometric Coefficient of Variation 235.3 |
| Treatment 2 | Ctrough Measurements Overtime | Week 8 | 112.852 ng/mL | Geometric Coefficient of Variation 1125.2 |
| Treatment 2 | Ctrough Measurements Overtime | Week 2 | 191.509 ng/mL | Geometric Coefficient of Variation 349.3 |
| Treatment 2 | Ctrough Measurements Overtime | Week 1 | 138.950 ng/mL | Geometric Coefficient of Variation 735.3 |
| Treatment 2 | Ctrough Measurements Overtime | Week 4 | 153.285 ng/mL | Geometric Coefficient of Variation 618.6 |
| Treatment 2 | Ctrough Measurements Overtime | Week 12 | 82.047 ng/mL | Geometric Coefficient of Variation 3201.7 |
Secondary
Mean Change Frome Baseline of PASI Scores Overtime
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.
Time frame: From start of treatment (Week 1) to Week 2, 4, 8, and 12
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change Frome Baseline of PASI Scores Overtime | Week 8 | -3.73 PASI Score on a Scale | Standard Deviation 7.521 |
| Placebo | Mean Change Frome Baseline of PASI Scores Overtime | Week 4 | -3.97 PASI Score on a Scale | Standard Deviation 7.872 |
| Placebo | Mean Change Frome Baseline of PASI Scores Overtime | Week 1 | -0.50 PASI Score on a Scale | Standard Deviation 5.765 |
| Placebo | Mean Change Frome Baseline of PASI Scores Overtime | Week 2 | -3.30 PASI Score on a Scale | Standard Deviation 5.803 |
| Placebo | Mean Change Frome Baseline of PASI Scores Overtime | Week 12 | -4.43 PASI Score on a Scale | Standard Deviation 8.03 |
| Treatment 1 | Mean Change Frome Baseline of PASI Scores Overtime | Week 8 | -13.34 PASI Score on a Scale | Standard Deviation 5.734 |
| Treatment 1 | Mean Change Frome Baseline of PASI Scores Overtime | Week 2 | -5.16 PASI Score on a Scale | Standard Deviation 4.856 |
| Treatment 1 | Mean Change Frome Baseline of PASI Scores Overtime | Week 4 | -8.53 PASI Score on a Scale | Standard Deviation 6.311 |
| Treatment 1 | Mean Change Frome Baseline of PASI Scores Overtime | Week 1 | -2.85 PASI Score on a Scale | Standard Deviation 3.782 |
| Treatment 1 | Mean Change Frome Baseline of PASI Scores Overtime | Week 12 | -14.55 PASI Score on a Scale | Standard Deviation 6.644 |
| Treatment 2 | Mean Change Frome Baseline of PASI Scores Overtime | Week 2 | -7.13 PASI Score on a Scale | Standard Deviation 6.699 |
| Treatment 2 | Mean Change Frome Baseline of PASI Scores Overtime | Week 8 | -13.66 PASI Score on a Scale | Standard Deviation 8.265 |
| Treatment 2 | Mean Change Frome Baseline of PASI Scores Overtime | Week 1 | -2.95 PASI Score on a Scale | Standard Deviation 4.525 |
| Treatment 2 | Mean Change Frome Baseline of PASI Scores Overtime | Week 4 | -10.63 PASI Score on a Scale | Standard Deviation 7.512 |
| Treatment 2 | Mean Change Frome Baseline of PASI Scores Overtime | Week 12 | -15.39 PASI Score on a Scale | Standard Deviation 8.971 |
| Treatment 3 | Mean Change Frome Baseline of PASI Scores Overtime | Week 2 | -6.27 PASI Score on a Scale | Standard Deviation 5.421 |
| Treatment 3 | Mean Change Frome Baseline of PASI Scores Overtime | Week 8 | -14.06 PASI Score on a Scale | Standard Deviation 6.452 |
| Treatment 3 | Mean Change Frome Baseline of PASI Scores Overtime | Week 4 | -10.05 PASI Score on a Scale | Standard Deviation 6.629 |
| Treatment 3 | Mean Change Frome Baseline of PASI Scores Overtime | Week 12 | -15.44 PASI Score on a Scale | Standard Deviation 6.429 |
| Treatment 3 | Mean Change Frome Baseline of PASI Scores Overtime | Week 1 | -3.36 PASI Score on a Scale | Standard Deviation 4.047 |
Secondary
Percentage of Participants Achiving PASI-100 at Week 12
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.
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achiving PASI-100 at Week 12 | 0 Percentage of Participants |
| Treatment 1 | Percentage of Participants Achiving PASI-100 at Week 12 | 0 Percentage of Participants |
| Treatment 2 | Percentage of Participants Achiving PASI-100 at Week 12 | 15.4 Percentage of Participants |
| Treatment 3 | Percentage of Participants Achiving PASI-100 at Week 12 | 3.7 Percentage of Participants |
Secondary
Percentage of Participants Achiving PASI-50 at Week 12
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.
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achiving PASI-50 at Week 12 | 17.9 Percentage of Participants |
| Treatment 1 | Percentage of Participants Achiving PASI-50 at Week 12 | 73.9 Percentage of Participants |
| Treatment 2 | Percentage of Participants Achiving PASI-50 at Week 12 | 92.3 Percentage of Participants |
| Treatment 3 | Percentage of Participants Achiving PASI-50 at Week 12 | 81.5 Percentage of Participants |
Secondary
Percentage of Participants Achiving PASI-90 at Week 12
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.
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achiving PASI-90 at Week 12 | 3.6 Percentage of Participants |
| Treatment 1 | Percentage of Participants Achiving PASI-90 at Week 12 | 13.0 Percentage of Participants |
| Treatment 2 | Percentage of Participants Achiving PASI-90 at Week 12 | 61.5 Percentage of Participants |
| Treatment 3 | Percentage of Participants Achiving PASI-90 at Week 12 | 40.7 Percentage of Participants |
Secondary
Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12
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.
Time frame: 12 Weeks
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12 | 3.6 Percentage |
| Treatment 1 | Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12 | 54.2 Percentage |
| Treatment 2 | Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12 | 69.2 Percentage |
| Treatment 3 | Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12 | 55.6 Percentage |
Secondary
Tmax at Day 15
time to maximum observed concentration
Time frame: At Day 15 post first dose
Population: All participants who were treated with BMS-986322 and with Tmax measurements
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Tmax at Day 15 | 1.0830 hours |
| Treatment 1 | Tmax at Day 15 | 1.0415 hours |
| Treatment 2 | Tmax at Day 15 | 2.000 hours |