An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea (POETYK-PSO-3)
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BMS-986165
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Plaque psoriasis for at least 6 months
- Moderate to severe disease
- Candidate for phototherapy or systemic therapy
Exclusion Criteria:
- Other forms of psoriasis
- History of recent infection
- Prior exposure to BMS-986165
Other inclusion/exclusion criteria may apply.
Sites / Locations
- Local Institution - 0001
- Local Institution - 0007
- Local Institution - 0014
- Local Institution - 0008
- Local Institution - 0011
- Local Institution - 0016
- Local Institution
- Local Institution
- Local Institution - 0002
- Local Institution - 0006
- Local Institution - 0018
- Local Institution - 0012
- Local Institution
- Local Institution - 0009
- Local Institution - 0003
- Local Institution - 0004
- Local Institution - 0034
- Local Institution - 0033
- Local Institution - 0028
- Local Institution - 0035
- Local Institution - 0022
- Local Institution - 0037
- Local Institution - 0020
- Local Institution - 0036
- Local Institution - 0026
- Local Institution
- Local Institution - 0021
- Local Institution - 0027
- Local Institution - 0024
- Local Institution - 0023
- Local Institution - 0029
- Local Institution - 0031
- Local Institution - 0032
- Local Institution - 0025
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm A:BMS-986165 oral administration
Arm B: Placebo oral administration
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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:
0-1 = no effect at all on participant's life
2-5 = small effect on participant's life
6-10 = moderate effect on participant's life
11-20 = very large effect on participant's life
21-30 = extremely large effect on participant's life
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
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.
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.
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.
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.
Full Information
NCT ID
NCT04167462
First Posted
November 15, 2019
Last Updated
February 8, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT04167462
Brief Title
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea
Acronym
POETYK-PSO-3
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 25, 2019 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
January 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A:BMS-986165 oral administration
Arm Type
Experimental
Arm Title
Arm B: Placebo oral administration
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Description
Specified dose on Specified Days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on Specified days
Primary Outcome Measure Information:
Title
The Percentage of Participants With sPGA Response of 0 or 1
Description
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.
Time Frame
At week 16
Title
The Percentage of Participants With PASI 75 Response
Description
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.
Time Frame
At week 16
Secondary Outcome Measure Information:
Title
The Percentage of Participants With PASI 90 Response
Description
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.
Time Frame
At week 16
Title
The Percentage of Participants With PASI 100 Response
Description
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.
Time Frame
At week 16
Title
The Percentage of Participants With sPGA 0 Response
Description
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.
Time Frame
At week 16
Title
Change From Baseline in PSSD Symptom Score
Description
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.
Time Frame
Baseline and at Week 16
Title
The Percentage of Participants With Ss-PGA Score of 0 or 1
Description
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.
Time Frame
At week 16
Title
The Percentage of Participants With DLQI Score of 0 or 1
Description
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:
0-1 = no effect at all on participant's life
2-5 = small effect on participant's life
6-10 = moderate effect on participant's life
11-20 = very large effect on participant's life
21-30 = extremely large effect on participant's life
Time Frame
At week 16
Title
The Percentage of Participants With PGA-F Score of 0 or 1
Description
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
Time Frame
At week 16
Title
The Percentage of Participants With PSSD Symptom Score of 0
Description
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.
Time Frame
At week 16
Title
The Percentage of Participants With Pp-PGA Score of 0 or 1
Description
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.
Time Frame
At week 16
Title
The Percentage of Participants With PASI 75 Response at Week 52
Description
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.
Time Frame
At week 52
Title
The Percentage of Participants With sPGA Response of 0 or 1 at Week 52
Description
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.
Time Frame
At week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Plaque psoriasis for at least 6 months
Moderate to severe disease
Candidate for phototherapy or systemic therapy
Exclusion Criteria:
Other forms of psoriasis
History of recent infection
Prior exposure to BMS-986165
Other inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0001
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Local Institution - 0007
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Local Institution - 0014
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Facility Name
Local Institution - 0008
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
630014
Country
China
Facility Name
Local Institution - 0011
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Local Institution - 0016
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Local Institution
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Local Institution - 0002
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution - 0006
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Facility Name
Local Institution - 0018
City
Taiyuan
State/Province
Shan1xi
ZIP/Postal Code
030001
Country
China
Facility Name
Local Institution - 0012
City
Jingan
State/Province
Shanghai
ZIP/Postal Code
200443
Country
China
Facility Name
Local Institution
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution - 0009
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Local Institution - 0003
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Facility Name
Local Institution - 0004
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Facility Name
Local Institution - 0034
City
Bucheon-si
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Local Institution - 0033
City
Goyang-si
ZIP/Postal Code
10380
Country
Korea, Republic of
Facility Name
Local Institution - 0028
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Local Institution - 0035
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Local Institution - 0022
City
Seongnam-si
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Local Institution - 0037
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Local Institution - 0020
City
Seoul.
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Local Institution - 0036
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Local Institution - 0026
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution - 0021
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Local Institution - 0027
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Local Institution - 0024
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution - 0023
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Local Institution - 0029
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Local Institution - 0031
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Local Institution - 0032
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Local Institution - 0025
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea
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