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)

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: BMS-986165; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Local Institution - 0001
    • Beijing, Beijing, China, 100050
      • Local Institution - 0007
    • Beijing, Beijing, China, 100069
      • Local Institution - 0014
  • Chongqing
    • Chongqing, Chongqing, China, 630014
      • Local Institution - 0008
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Local Institution - 0011
    • Wuhan, Hubei, China, 430030
      • Local Institution - 0016
  • Hunan
    • Changsha, Hunan, China, 410011
      • Local Institution
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Local Institution
  • Jilin
    • Changchun, Jilin, China, 130021
      • Local Institution - 0002
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • Local Institution - 0006
  • Shan1xi
    • Taiyuan, Shan1xi, China, 030001
      • Local Institution - 0018
  • Shanghai
    • Jingan, Shanghai, China, 200443
      • Local Institution - 0012
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Local Institution
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Local Institution - 0009
    • Hangzhou, Zhejiang, China, 310014
      • Local Institution - 0003
    • Hangzhou, Zhejiang, China, 310016
      • Local Institution - 0004
• Korea, Republic of
  • Bucheon-si, Korea, Republic of, 14584
    • Local Institution - 0034
  • Goyang-si, Korea, Republic of, 10380
    • Local Institution - 0033
  • Gwangju, Korea, Republic of, 61469
    • Local Institution - 0028
  • Incheon, Korea, Republic of, 21565
    • Local Institution - 0035
  • Seongnam-si, Korea, Republic of, 13496
    • Local Institution - 0022
  • Seongnam-si, Korea, Republic of, 13620
    • Local Institution - 0037
  • Seoul, Korea, Republic of, 02447
    • Local Institution - 0036
  • Seoul, Korea, Republic of, 03080
    • Local Institution - 0026
  • Seoul, Korea, Republic of, 03722
    • Local Institution
  • Seoul, Korea, Republic of, 05030
    • Local Institution - 0021
  • Seoul, Korea, Republic of, 08308
    • Local Institution - 0027
  • Seoul, Korea, Republic of, 137-701
    • Local Institution - 0024
  • Seoul., Korea, Republic of, 06973
    • Local Institution - 0020
  • Suwon, Korea, Republic of, 16499
    • Local Institution - 0023
• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Local Institution - 0029
  • Taipei, Taiwan, 10002
    • Local Institution - 0031
  • Taipei, Taiwan, 11490
    • Local Institution - 0032
  • Taoyuan, Taiwan, 33305
    • Local Institution - 0025

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A:BMS-986165 oral administration	Drug: BMS-986165; Specified dose on Specified Days
Placebo Comparator: Arm B: Placebo oral administration	Other: Placebo; Specified dose on Specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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: 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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Actual): March 8, 2021
• Study Completion (Actual): January 7, 2022

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 15, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; BMS-986165
• Other Study ID Numbers: IM011-065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No