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

Psoriasis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04167462
• Other study ID #: IM011-065
• Status: Completed
• Phase: Phase 3
• Start date: November 25, 2019
• Est. completion date: January 7, 2022

Study information

• Verified date: February 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 7, 2022
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BMS-986165
Specified dose on Specified Days

Other:
• Placebo
Specified dose on Specified days

Locations

Country	Name	City	State
China	Local Institution - 0001	Beijing	Beijing
China	Local Institution - 0007	Beijing	Beijing
China	Local Institution - 0014	Beijing	Beijing
China	Local Institution - 0002	Changchun	Jilin
China	Local Institution	Changsha	Hunan
China	Local Institution	Chengdu	Sichuan
China	Local Institution - 0008	Chongqing	Chongqing
China	Local Institution - 0006	Dalian	Liaoning
China	Local Institution - 0003	Hangzhou	Zhejiang
China	Local Institution - 0004	Hangzhou	Zhejiang
China	Local Institution - 0009	Hangzhou	Zhejiang
China	Local Institution - 0012	Jingan	Shanghai
China	Local Institution	Nanjing	Jiangsu
China	Local Institution - 0018	Taiyuan	Shan1xi
China	Local Institution - 0011	Wuhan	Hubei
China	Local Institution - 0016	Wuhan	Hubei
Korea, Republic of	Local Institution - 0034	Bucheon-si
Korea, Republic of	Local Institution - 0033	Goyang-si
Korea, Republic of	Local Institution - 0028	Gwangju
Korea, Republic of	Local Institution - 0035	Incheon
Korea, Republic of	Local Institution - 0022	Seongnam-si
Korea, Republic of	Local Institution - 0037	Seongnam-si
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution - 0021	Seoul
Korea, Republic of	Local Institution - 0024	Seoul
Korea, Republic of	Local Institution - 0026	Seoul
Korea, Republic of	Local Institution - 0027	Seoul
Korea, Republic of	Local Institution - 0036	Seoul
Korea, Republic of	Local Institution - 0020	Seoul.
Korea, Republic of	Local Institution - 0023	Suwon
Taiwan	Local Institution - 0029	Kaohsiung
Taiwan	Local Institution - 0031	Taipei
Taiwan	Local Institution - 0032	Taipei
Taiwan	Local Institution - 0025	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	At week 16
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.	At week 16
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.	At week 16
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.	At week 16
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.	At week 16
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.	Baseline and at Week 16
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.	At week 16
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: 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	At week 16
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	At week 16
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.	At week 16
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.	At week 16
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.	At week 52
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.	At week 52

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