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The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo in participants with moderate to severe plaque psoriasis in mainland China, Taiwan, and South Korea
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A:BMS-986165 oral administration | Experimental |
| |
| Arm B: Placebo oral administration | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Specified dose on Specified Days |
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| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With sPGA Response of 0 or 1 | static Physician Global Assessment (sPGA) 0 or 1 response assessed as a percentage of participants with a sPGA score of 0 or 1 as assessed at week 16 with at least a 2-point improvement from baseline. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score. | At week 16 |
| The Percentage of Participants With PASI 75 Response | Psoriasis Area and Severity Index (PASI) 75 response is an assessment defined as the percentage of participants who experience at least a 75% improvement in PASI score at Week 16 as compared with baseline value. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), 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 includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment. | At week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With PASI 90 Response | Psoriasis Area and Severity Index (PASI) 90 response is an assessment defined as the percentage of participants who experience at least a 90% improvement in PASI score at Week 16 as compared with baseline value. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), 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 includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment. |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Beijing | Beijing Municipality | 100044 | China | ||
| Local Institution - 0007 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40671612 | Derived | Zhang J, Ding Y, Wang P, Li L, Pan W, Lu Y, Cheng H, Jiang X, Ho JC, Guo S, Seo SJ, Gold LS, Blauvelt A, Zhuo J, Zhong Y, Becker B, Liu L, Banerjee S, Thaci D. Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Asian Patients With Moderate to Severe Psoriasis: Improvements in Patient-Reported Outcomes in a Randomized Trial. J Dermatol. 2025 Sep;52(9):1360-1367. doi: 10.1111/1346-8138.17834. Epub 2025 Jul 17. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: BMS-986165 | Participants received a 6 mg tablet of BMS-986165 once daily |
| FG001 | Arm 2: Placebo | Participants received a placebo tablet once daily. After Week 16, participants were transferred to a 6 mg tablet of BMS-986165 once daily |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 11, 2020 | Oct 6, 2022 |
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| Placebo |
| Other |
Specified dose on Specified days |
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| At week 16 |
| The Percentage of Participants With PASI 100 Response | Psoriasis Area and Severity Index (PASI) 100 response is an assessment defined as the percentage of participants who experience at least a 100% improvement in PASI score at Week 16 as compared with baseline value. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), 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 includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment. | At week 16 |
| The Percentage of Participants With sPGA 0 Response | static Physician Global Assessment (sPGA) 0 response is defined as the percentage of participants with a sPGA score of 0 with at least 2-point improvement from baseline as assessed at Week 16. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score. | At week 16 |
| Change From Baseline in PSSD Symptom Score | Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptom score is defined as the percentage of participants with a PSSD score of 0 among participants with a baseline PSSD symptom score ≥ 1. The PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions and multiplying by 10. A sign score will be derived by averaging the 6 questions and multiplying by 10. A total PSSD score with range 0-100 will be derived from taking the average of the symptom and sign scores. | Baseline and at Week 16 |
| The Percentage of Participants With Ss-PGA Score of 0 or 1 | Scalp specific Physician's Global Assessment (ss-PGA) 0 or 1 assessed at Week 16 as a percentage of participants with a ss-PGA score 0 or 1 among participants with a baseline ss-PGA score ≥3. The ss-PGA is assessed at each visit throughout the study in participants that have evidence of scalp psoriasis at baseline. If there is evidence of scalp involvement, scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. | At week 16 |
| The Percentage of Participants With DLQI Score of 0 or 1 | Dermatology Life Quality Index 0 or 1 assessed at Week 16 as a percentage of participants with a DLQI score of 0 or 1 among participants with a baseline DLQI score ≥2. The DLQI is a participant-reported quality of life index 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 scale of 0 to 3 where a higher value signifies higher severity, with 0="not at all", 1="a little", 2="a lot", or 3="very much". The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). Interpretation of DLQI scores is as follows:
| At week 16 |
| The Percentage of Participants With PGA-F Score of 0 or 1 | Physician's Global Assessment of Fingernail Psoriasis (PGA-F) score of 0 or 1 assessed at Week 16 as a percentage of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score ≥3. If a participant shows evidence of psoriatic fingernail involvement, the assessment will be performed at each subsequent visit to assess severity and improvement over time. Only participants with a PGA-F score at baseline will be assessed throughout the study. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe | At week 16 |
| The Percentage of Participants With PSSD Symptom Score of 0 | Psoriasis Symptoms and Signs Diary (PSSD) symptom score of 0 assessed as a percentage of participants with a PSSD symptom score of 0 among participants with a baseline PSSD symptom score ≥1. The PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions included in the symptom score and multiplying by 10. scores range from 0-100, where 0 representing the least severe symptom and 100 the most severe. | At week 16 |
| The Percentage of Participants With Pp-PGA Score of 0 or 1 | Palmoplantar PGA (pp-PGA) 0/1 assessed as a percentage of participants with a pp-PGA score of 0 or 1 among participants with a baseline pp-PGA score ≥3. This measure will be used for participants with palmoplantar (finger and toe surfaces) involvement at baseline. Only participants with baseline palmoplantar involvement will continue to have these assessments at each subsequent visit throughout the study. The pp-PGA uses a 5-point (0-4) overall severity scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. | At week 16 |
| The Percentage of Participants With PASI 75 Response at Week 52 | Psoriasis Area and Severity Index (PASI) 75 response is an assessment defined as the percentage of participants who experience at least a 75% improvement in PASI score at Week 52 as compared with participants that are PASI 75 responders at Week 16. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), 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 includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment. | At week 52 |
| The Percentage of Participants With sPGA Response of 0 or 1 at Week 52 | static Physician Global Assessment (sPGA) 0 or 1 response assessed as a percentage of participants with a sPGA score of 0 or 1 as assessed at week 52 among participants that are sPGA 0 or 1 responders at Week 16. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score. | At week 52 |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Local Institution - 0014 | Beijing | Beijing Municipality | 100069 | China |
| Local Institution - 0008 | Chongqing | Chongqing Municipality | 630014 | China |
| Local Institution - 0011 | Wuhan | Hubei | 430022 | China |
| Local Institution - 0016 | Wuhan | Hubei | 430030 | China |
| Local Institution | Changsha | Hunan | 410011 | China |
| Local Institution | Nanjing | Jiangsu | 210029 | China |
| Local Institution - 0002 | Changchun | Jilin | 130021 | China |
| Local Institution - 0006 | Dalian | Liaoning | 116011 | China |
| Local Institution - 0018 | Taiyuan | Shan1xi | 030001 | China |
| Local Institution - 0012 | Jingan | Shanghai Municipality | 200443 | China |
| Local Institution | Chengdu | Sichuan | 610041 | China |
| Local Institution - 0009 | Hangzhou | Zhejiang | 310003 | China |
| Local Institution - 0003 | Hangzhou | Zhejiang | 310014 | China |
| Local Institution - 0004 | Hangzhou | Zhejiang | 310016 | China |
| Local Institution - 0034 | Bucheon-si | 14584 | South Korea |
| Local Institution - 0033 | Goyang-si | 10380 | South Korea |
| Local Institution - 0028 | Gwangju | 61469 | South Korea |
| Local Institution - 0035 | Incheon | 21565 | South Korea |
| Local Institution - 0022 | Seongnam-si | 13496 | South Korea |
| Local Institution - 0037 | Seongnam-si | 13620 | South Korea |
| Local Institution - 0036 | Seoul | 02447 | South Korea |
| Local Institution - 0026 | Seoul | 03080 | South Korea |
| Local Institution | Seoul | 03722 | South Korea |
| Local Institution - 0021 | Seoul | 05030 | South Korea |
| Local Institution - 0020 | Seoul | 06973 | South Korea |
| Local Institution - 0027 | Seoul | 08308 | South Korea |
| Local Institution - 0024 | Seoul | 137-701 | South Korea |
| Local Institution - 0023 | Suwon | 16499 | South Korea |
| Local Institution - 0029 | Kaohsiung City | 83301 | Taiwan |
| Local Institution - 0031 | Taipei | 10002 | Taiwan |
| Local Institution - 0032 | Taipei | 11490 | Taiwan |
| Local Institution - 0025 | Taoyuan | 33305 | Taiwan |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: BMS-986165 | Participants received a 6 mg tablet of BMS-986165 once daily |
| BG001 | Arm 2: Placebo | Participants received a placebo tablet once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The Percentage of Participants With sPGA Response of 0 or 1 | static Physician Global Assessment (sPGA) 0 or 1 response assessed as a percentage of participants with a sPGA score of 0 or 1 as assessed at week 16 with at least a 2-point improvement from baseline. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score. | All treated participants. Participants missing results at week 16 due to COVID-19 are excluded. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 16 |
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| Primary | The Percentage of Participants With PASI 75 Response | Psoriasis Area and Severity Index (PASI) 75 response is an assessment defined as the percentage of participants who experience at least a 75% improvement in PASI score at Week 16 as compared with baseline value. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), 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 includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment. | All treated participants. Participants missing results at week 16 due to COVID-19 are excluded. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 16 |
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| Secondary | The Percentage of Participants With PASI 90 Response | Psoriasis Area and Severity Index (PASI) 90 response is an assessment defined as the percentage of participants who experience at least a 90% improvement in PASI score at Week 16 as compared with baseline value. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), 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 includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment. | All treated participants. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 16 |
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| Secondary | The Percentage of Participants With PASI 100 Response | Psoriasis Area and Severity Index (PASI) 100 response is an assessment defined as the percentage of participants who experience at least a 100% improvement in PASI score at Week 16 as compared with baseline value. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), 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 includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment. | All treated participants. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 16 |
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| Secondary | The Percentage of Participants With sPGA 0 Response | static Physician Global Assessment (sPGA) 0 response is defined as the percentage of participants with a sPGA score of 0 with at least 2-point improvement from baseline as assessed at Week 16. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score. | All treated participants. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 16 |
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| Secondary | Change From Baseline in PSSD Symptom Score | Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptom score is defined as the percentage of participants with a PSSD score of 0 among participants with a baseline PSSD symptom score ≥ 1. The PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions and multiplying by 10. A sign score will be derived by averaging the 6 questions and multiplying by 10. A total PSSD score with range 0-100 will be derived from taking the average of the symptom and sign scores. | Participants with a baseline PSSD symptom score ≥ 1. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and at Week 16 |
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| Secondary | The Percentage of Participants With Ss-PGA Score of 0 or 1 | Scalp specific Physician's Global Assessment (ss-PGA) 0 or 1 assessed at Week 16 as a percentage of participants with a ss-PGA score 0 or 1 among participants with a baseline ss-PGA score ≥3. The ss-PGA is assessed at each visit throughout the study in participants that have evidence of scalp psoriasis at baseline. If there is evidence of scalp involvement, scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. | Participants with a baseline ss-PGA score ≥3. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 16 |
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| Secondary | The Percentage of Participants With DLQI Score of 0 or 1 | Dermatology Life Quality Index 0 or 1 assessed at Week 16 as a percentage of participants with a DLQI score of 0 or 1 among participants with a baseline DLQI score ≥2. The DLQI is a participant-reported quality of life index 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 scale of 0 to 3 where a higher value signifies higher severity, with 0="not at all", 1="a little", 2="a lot", or 3="very much". The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). Interpretation of DLQI scores is as follows:
| Participants with a baseline DLQI score ≥2. Pre-specified data collected for Arms 1 and 2 at Week 16. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 16 |
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| Secondary | The Percentage of Participants With PGA-F Score of 0 or 1 | Physician's Global Assessment of Fingernail Psoriasis (PGA-F) score of 0 or 1 assessed at Week 16 as a percentage of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score ≥3. If a participant shows evidence of psoriatic fingernail involvement, the assessment will be performed at each subsequent visit to assess severity and improvement over time. Only participants with a PGA-F score at baseline will be assessed throughout the study. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe | Participants with a baseline PGA-F score ≥3. Participants missing results at week 16 due to COVID-19 are excluded. Pre-specified data collected for Arms 1 and 2 at Week 16. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 16 |
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| Secondary | The Percentage of Participants With PSSD Symptom Score of 0 | Psoriasis Symptoms and Signs Diary (PSSD) symptom score of 0 assessed as a percentage of participants with a PSSD symptom score of 0 among participants with a baseline PSSD symptom score ≥1. The PSSD is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0-10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). A symptom score will be derived by averaging the 5 questions included in the symptom score and multiplying by 10. scores range from 0-100, where 0 representing the least severe symptom and 100 the most severe. | Participants with a baseline PSSD symptom score ≥1. Pre-specified data collected for Arms 1 and 2 at Week 16. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 16 |
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| Secondary | The Percentage of Participants With Pp-PGA Score of 0 or 1 | Palmoplantar PGA (pp-PGA) 0/1 assessed as a percentage of participants with a pp-PGA score of 0 or 1 among participants with a baseline pp-PGA score ≥3. This measure will be used for participants with palmoplantar (finger and toe surfaces) involvement at baseline. Only participants with baseline palmoplantar involvement will continue to have these assessments at each subsequent visit throughout the study. The pp-PGA uses a 5-point (0-4) overall severity scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. | Participants with a baseline pp-PGA score ≥3. Pre-specified data collected for Arms 1 and 2 at Week 16. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 16 |
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| Secondary | The Percentage of Participants With PASI 75 Response at Week 52 | Psoriasis Area and Severity Index (PASI) 75 response is an assessment defined as the percentage of participants who experience at least a 75% improvement in PASI score at Week 52 as compared with participants that are PASI 75 responders at Week 16. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), 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 includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment. | All treated participants. Data is represented from participants original randomization arm. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 52 |
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| Secondary | The Percentage of Participants With sPGA Response of 0 or 1 at Week 52 | static Physician Global Assessment (sPGA) 0 or 1 response assessed as a percentage of participants with a sPGA score of 0 or 1 as assessed at week 52 among participants that are sPGA 0 or 1 responders at Week 16. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 52 |
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SAEs and NSAEs: From first dose to 100 days post last dose (up to approximately 15 months). All-Cause Mortality: From first dose through the course of the trial (up to approximately 24 months).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Week 0 up to Week 16 | Participants received a placebo tablet once daily from Week 0 up to Week 16 | 0 | 74 | 3 | 74 | 29 | 74 |
| EG001 | BMS-986165 Week 0 up to Week 52 | Participants received a 6 mg tablet of BMS-986165 once daily from Week 0 up to Week 52 | 0 | 146 | 4 | 146 | 55 | 146 |
| EG002 | BMS-986165 Week 16 up to Week 52 | Participants from the placebo group were switched to receive a 6 mg tablet of BMS-986165 once daily from Week 16 up to Week 52. | 0 | 68 | 0 | 68 | 19 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Gastroenteritis shigella | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Hepatobiliary procedural complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Cyst | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trails@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 22, 2021 | Oct 6, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
Not provided
Not provided
Not provided
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