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

NCT04167462 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: IM011-065
• Study Type: interventional
• Target: 220
• Locations: 3 countries
• Sites: 34

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• The Percentage of Participants With PASI 90 Response

  At week 16

• The Percentage of Participants With PASI 100 Response

  At week 16

• The Percentage of Participants With sPGA 0 Response

  At week 16

• Change From Baseline in PSSD Symptom Score

  Baseline and at Week 16

• The Percentage of Participants With Ss-PGA Score of 0 or 1

  At week 16

Study Arms (2)

Arm A:BMS-986165 oral administration

EXPERIMENTAL

Drug: BMS-986165

Arm B: Placebo oral administration

PLACEBO COMPARATOR

Other: Placebo

Interventions

BMS-986165 DRUG

Specified dose on Specified Days

Arm A:BMS-986165 oral administration

Placebo OTHER

Specified dose on Specified days

Arm B: Placebo oral administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Plaque psoriasis for at least 6 months
• Moderate to severe disease
• Candidate for phototherapy or systemic therapy

You may not qualify if:

• Other forms of psoriasis
• History of recent infection
• Prior exposure to BMS-986165

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (34)

Local Institution - 0001

Beijing, Beijing Municipality, 100044, China

Location

Local Institution - 0007

Beijing, Beijing Municipality, 100050, China

Location

Local Institution - 0014

Beijing, Beijing Municipality, 100069, China

Location

Local Institution - 0008

Chongqing, Chongqing Municipality, 630014, China

Location

Local Institution - 0011

Wuhan, Hubei, 430022, China

Location

Local Institution - 0016

Wuhan, Hubei, 430030, China

Location

Local Institution

Changsha, Hunan, 410011, China

Location

Local Institution

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 0002

Changchun, Jilin, 130021, China

Location

Local Institution - 0006

Dalian, Liaoning, 116011, China

Location

Local Institution - 0018

Taiyuan, Shan1xi, 030001, China

Location

Local Institution - 0012

Jingan, Shanghai Municipality, 200443, China

Location

Local Institution

Chengdu, Sichuan, 610041, China

Location

Local Institution - 0009

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0003

Hangzhou, Zhejiang, 310014, China

Location

Local Institution - 0004

Hangzhou, Zhejiang, 310016, China

Location

Local Institution - 0034

Bucheon-si, 14584, South Korea

Location

Local Institution - 0033

Goyang-si, 10380, South Korea

Location

Local Institution - 0028

Gwangju, 61469, South Korea

Location

Local Institution - 0035

Incheon, 21565, South Korea

Location

Local Institution - 0022

Seongnam-si, 13496, South Korea

Location

Local Institution - 0037

Seongnam-si, 13620, South Korea

Location

Local Institution - 0036

Seoul, 02447, South Korea

Location

Local Institution - 0026

Seoul, 03080, South Korea

Location

Local Institution

Seoul, 03722, South Korea

Location

Local Institution - 0021

Seoul, 05030, South Korea

Location

Local Institution - 0020

Seoul, 06973, South Korea

Location

Local Institution - 0027

Seoul, 08308, South Korea

Location

Local Institution - 0024

Seoul, 137-701, South Korea

Location

Local Institution - 0023

Suwon, 16499, South Korea

Location

Local Institution - 0029

Kaohsiung City, 83301, Taiwan

Location

Local Institution - 0031

Taipei, 10002, Taiwan

Location

Local Institution - 0032

Taipei, 11490, Taiwan

Location

Local Institution - 0025

Taoyuan District, 33305, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 40671612 DERIVED

Related Links

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

MeSH Terms

Conditions

Psoriasis

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trails@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 18, 2019
• Study Start: November 25, 2019
• Primary Completion: March 8, 2021
• Study Completion: January 7, 2022
• Last Updated: March 8, 2023
• Results First Posted: November 2, 2022

Record last verified: 2023-02

Locations

KR (14); CN (16); TW (4)