Psoriasis
Conditions
Keywords
plaque psoriasis, deucravacitinib, BMS-986165, Health related quality of life (HrQoL), QoL (quality of life), SOTYKTU
Brief summary
The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.
Interventions
DRUGDeucravacitinib
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
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women diagnosed with stable plaque psoriasis for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator. * Deemed by the investigator to be a candidate for phototherapy or systemic therapy. * ≥ 3% of Body Surface Area (BSA) involvement at the Screening Visit and Day 1 * Dermatology Life Quality Index (DLQI) score \> 5 at the Screening Visit and Day 1 * Moderate-to-severe plaque psoriasis as defined by static Physician Global Assessment (s-PGA) ≥ 3 at the Screening Visit and Day 1
Exclusion criteria
Target Disease Exceptions: * Non-plaque psoriasis (that is, guttate, pustular, erythrodermic, palmoplantar only involvement or drug-induced psoriasis) at Screening Visit or Day 1 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | At Week 16 | Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a 4-point scale: 0=not at all 1. a little 2. a lot 3. very much The scores are added up to give a total score between 0 and 30. A lower total score means a better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 | At Week 16 | The Dermatology Life Quality Index (DLQI) is a simple, 10-question survey used to measure the impact of skin conditions on a patient's quality of life. It assesses how much a skin condition affects various aspects of daily life, including symptoms, feelings, daily activities, work or school, personal relationships, and treatment. The DLQI is scored by summing the responses to its 10 questions. Each question is scored on a scale from 0 to 3: 0 = Not at all 1. = A little 2. = A lot 3. = Very much The total score ranges from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life. |
| Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16 | Baseline and at Week 16 | The whole-body itch Numerical Rating Scale (NRS) is a survey that participants fill out themselves. It uses an 11-point scale from 0 to 10, where 0 means 'no itch' and 10 means 'worst itch imaginable.' Participants indicate the severity of their itching from psoriasis by selecting the number that best describes the worst level of itching they experienced in the past 24 hours. A lower score means better outcomes, indicating less severe itching. |
| Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16 | At Week 16 | The Static Physician's Global Assessment (s-PGA) is a 5-point scale to evaluate the average severity of all psoriatic lesions based on redness, scaling, and thickness. The s-PGA measures psoriasis severity at a single point in time, without considering the initial condition. The scale rates the severity as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A lower score means better outcomes, indicating less severe psoriasis. |
| Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16 | From Week 0 through Week 16 | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. |
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16 | From Week 0 through Week 16 | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. |
| Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 | From Week 0 through Week 16 | Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper limit of normal |
| Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 | From Week 0 through Week 16 | Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening. |
| Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | From Week 0 through Week 16 | Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure. |
| Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16 | From Week 0 through Week 16 | Vital Sign Measurements include: Body Temperature (C), Respiratory Rate (breaths/min), Seated Blood Pressure (mmHg) and Heart Rate (beats/min). Clinically significant changes in these measurements may need medical attention as they could indicate a potential health concern. |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Participant flow
Pre-assignment details
A total of 180 participants were randomized and of these 178 received at least one dose of study treatment.
Participants by arm
| Arm | Count |
|---|---|
| BMS-986165 6mg QD Participants received deucravacitinib at a dose of 6 mg daily (QD) | 120 |
| Placebo Participants received placebo daily (QD) | 60 |
| Total | 180 |
Baseline characteristics
| Characteristic | Placebo | Total | BMS-986165 6mg QD |
|---|---|---|---|
| Age, Continuous | 47.5 Years STANDARD_DEVIATION 13.55 | 48.6 Years STANDARD_DEVIATION 14.46 | 49.1 Years STANDARD_DEVIATION 14.92 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 56 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 122 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 6 Participants | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 9 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 50 Participants | 158 Participants | 108 Participants |
| Sex: Female, Male Female | 20 Participants | 68 Participants | 48 Participants |
| Sex: Female, Male Male | 40 Participants | 112 Participants | 72 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 | 1 / 119 | 0 / 59 | 1 / 103 | 0 / 49 |
| other Total, other adverse events | 32 / 119 | 13 / 59 | 26 / 103 | 10 / 49 |
| serious Total, serious adverse events | 3 / 119 | 1 / 59 | 5 / 103 | 3 / 49 |
Outcome results
Primary
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16
Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a 4-point scale: 0=not at all 1. a little 2. a lot 3. very much The scores are added up to give a total score between 0 and 30. A lower total score means a better quality of life.
Time frame: At Week 16
Population: Full Analysis Set: All Randomized Participants Full Analysis Set Sub-Population: All Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BMS-986165 6mg QD | Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | Full Analysis Set | 33.3 Percentage of Participants |
| BMS-986165 6mg QD | Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | Full Analysis Set Sub-population | 32.7 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | Full Analysis Set | 6.7 Percentage of Participants |
| Placebo | Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | Full Analysis Set Sub-population | 6.1 Percentage of Participants |
Comparison: Full Analysis Setp-value: 0.000195% CI: [2.5, 23.6]Stratified Cochran-Mantel-Haenszel (CMH)
Comparison: Full Analysis Set Sub-populationp-value: 0.000395% CI: [2.4, 30.4]Stratified Cochran-Mantel-Haenszel (CMH)
Secondary
Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16
The whole-body itch Numerical Rating Scale (NRS) is a survey that participants fill out themselves. It uses an 11-point scale from 0 to 10, where 0 means 'no itch' and 10 means 'worst itch imaginable.' Participants indicate the severity of their itching from psoriasis by selecting the number that best describes the worst level of itching they experienced in the past 24 hours. A lower score means better outcomes, indicating less severe itching.
Time frame: Baseline and at Week 16
Population: Full Analysis Set: Randomized Participants Full Analysis Set Sub-Population: Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BMS-986165 6mg QD | Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16 | Full Analysis Set | -3.8 Score on a Scale | Standard Deviation 2.86 |
| BMS-986165 6mg QD | Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16 | Full Analysis Set Sub-population | -3.8 Score on a Scale | Standard Deviation 2.73 |
| Placebo | Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16 | Full Analysis Set | -1.8 Score on a Scale | Standard Deviation 2.78 |
| Placebo | Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16 | Full Analysis Set Sub-population | -1.8 Score on a Scale | Standard Deviation 2.7 |
Comparison: Full Analysis Setp-value: <0.000195% CI: [-2.9, -1.2]Covariance model
Comparison: Full Analysis Set Sub-populationp-value: <0.000195% CI: [-3, -1.3]Covariance model
Secondary
Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16
Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure.
Time frame: From Week 0 through Week 16
Population: As-treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-986165 6mg QD | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Heart Rate (Beats/Min): Value > 100 And Change From Baseline > 30 | 0 Participants |
| BMS-986165 6mg QD | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Systolic Blood Pressure (Mmhg): Not Reported | 0 Participants |
| BMS-986165 6mg QD | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Heart Rate (Beats/Min): Not Reported | 0 Participants |
| BMS-986165 6mg QD | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Diastolic Blood Pressure (Mmhg): Value > 90 And Change From Baseline > 10 | 19 Participants |
| BMS-986165 6mg QD | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Heart Rate (Beats/Min): Value < 55 And Change From Baseline < -15 | 0 Participants |
| BMS-986165 6mg QD | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Diastolic Blood Pressure (Mmhg): Value < 55 And Change From Baseline < -10 | 0 Participants |
| BMS-986165 6mg QD | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Systolic Blood Pressure (Mmhg): Value > 140 And Change From Baseline > 20 | 5 Participants |
| BMS-986165 6mg QD | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Diastolic Blood Pressure (Mmhg): Not Reported | 0 Participants |
| BMS-986165 6mg QD | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Systolic Blood Pressure (Mmhg): Value < 90 And Change From Baseline < -20 | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Diastolic Blood Pressure (Mmhg): Not Reported | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Systolic Blood Pressure (Mmhg): Value < 90 And Change From Baseline < -20 | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Heart Rate (Beats/Min): Value > 100 And Change From Baseline > 30 | 1 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Heart Rate (Beats/Min): Value < 55 And Change From Baseline < -15 | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Heart Rate (Beats/Min): Not Reported | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Systolic Blood Pressure (Mmhg): Value > 140 And Change From Baseline > 20 | 4 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Systolic Blood Pressure (Mmhg): Not Reported | 0 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Diastolic Blood Pressure (Mmhg): Value > 90 And Change From Baseline > 10 | 6 Participants |
| Placebo | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Diastolic Blood Pressure (Mmhg): Value < 55 And Change From Baseline < -10 | 1 Participants |
Secondary
Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16
Vital Sign Measurements include: Body Temperature (C), Respiratory Rate (breaths/min), Seated Blood Pressure (mmHg) and Heart Rate (beats/min). Clinically significant changes in these measurements may need medical attention as they could indicate a potential health concern.
Time frame: From Week 0 through Week 16
Population: As-treated Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BMS-986165 6mg QD | Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16 | 0 Participants |
| Placebo | Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16 | 0 Participants |
Secondary
Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16
Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening.
Time frame: From Week 0 through Week 16
Population: As-treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-986165 6mg QD | Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 | Hematology: Leukocytes (Grade 3) | 1 Participants |
| BMS-986165 6mg QD | Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 | Hematology: Platelets (Grade 4) | 1 Participants |
| BMS-986165 6mg QD | Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 | Chemistry: Potassium (Grade 3) | 1 Participants |
| Placebo | Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 | Hematology: Leukocytes (Grade 3) | 0 Participants |
| Placebo | Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 | Hematology: Platelets (Grade 4) | 0 Participants |
| Placebo | Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 | Chemistry: Potassium (Grade 3) | 0 Participants |
Secondary
Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16
Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper limit of normal
Time frame: From Week 0 through Week 16
Population: As-treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BMS-986165 6mg QD | Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 | Total Bilirubin > 2 X ULN | 0 Participants |
| BMS-986165 6mg QD | Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 | ALT or AST > 3 X ULN and Total Bilirubin > 2 X ULN on the same day | 0 Participants |
| BMS-986165 6mg QD | Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 | ALT or AST > 3 X ULN | 1 Participants |
| BMS-986165 6mg QD | Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 | ALT or AST > 5 X ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 | ALT or AST > 5 X ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 | Total Bilirubin > 2 X ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 | ALT or AST > 3 X ULN | 0 Participants |
| Placebo | Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 | ALT or AST > 3 X ULN and Total Bilirubin > 2 X ULN on the same day | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
Time frame: From Week 0 through Week 16
Population: As-treated Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BMS-986165 6mg QD | Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16 | 63 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16 | 25 Participants |
Secondary
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
Time frame: From Week 0 through Week 16
Population: As-treated Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BMS-986165 6mg QD | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16 | 3 Participants |
| Placebo | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16 | 1 Participants |
Secondary
Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
The Dermatology Life Quality Index (DLQI) is a simple, 10-question survey used to measure the impact of skin conditions on a patient's quality of life. It assesses how much a skin condition affects various aspects of daily life, including symptoms, feelings, daily activities, work or school, personal relationships, and treatment. The DLQI is scored by summing the responses to its 10 questions. Each question is scored on a scale from 0 to 3: 0 = Not at all 1. = A little 2. = A lot 3. = Very much The total score ranges from 0 to 30, with higher scores indicating a greater impact on the patient's quality of life.
Time frame: At Week 16
Population: Full Analysis Set: All Randomized Participants Full Analysis Set Sub-Population: All Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BMS-986165 6mg QD | Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 | Full Analysis Set | 72.5 Percentage of Participants |
| BMS-986165 6mg QD | Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 | Full Analysis Set Sub-population | 72.9 Percentage of Participants |
| Placebo | Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 | Full Analysis Set Sub-population | 53.1 Percentage of Participants |
| Placebo | Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 | Full Analysis Set | 53.3 Percentage of Participants |
Comparison: Full Analysis Setp-value: 0.010795% CI: [1.2, 4.4]Stratified Cochran-Mantel-Haenszel (CMH)
Comparison: Full Analysis Set Sub-populationp-value: 0.017595% CI: [1.2, 4.7]Stratified Cochran-Mantel-Haenszel (CMH)
Secondary
Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16
The Static Physician's Global Assessment (s-PGA) is a 5-point scale to evaluate the average severity of all psoriatic lesions based on redness, scaling, and thickness. The s-PGA measures psoriasis severity at a single point in time, without considering the initial condition. The scale rates the severity as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A lower score means better outcomes, indicating less severe psoriasis.
Time frame: At Week 16
Population: All randomized participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BMS-986165 6mg QD | Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16 | 35.5 Percentage of Participants |
| Placebo | Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16 | 8.2 Percentage of Participants |
Comparison: Full Analysis Set Sub-populationp-value: 0.000495% CI: [2, 17.4]Stratified Cochran-Mantel-Haenszel (CMH)