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

NCT ID: NCT04167462

Last Updated: 2023-03-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-25

Study Completion Date

2022-01-07

Brief Summary

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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

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm A:BMS-986165 oral administration

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Specified dose on Specified Days

Arm B: Placebo oral administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Specified dose on Specified days

Interventions

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BMS-986165

Specified dose on Specified Days

Intervention Type DRUG

Placebo

Specified dose on Specified days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Beijing, Beijing Municipality, China

Site Status

Local Institution - 0007

Beijing, Beijing Municipality, China

Site Status

Local Institution - 0014

Beijing, Beijing Municipality, China

Site Status

Local Institution - 0008

Chongqing, Chongqing Municipality, China

Site Status

Local Institution - 0011

Wuhan, Hubei, China

Site Status

Local Institution - 0016

Wuhan, Hubei, China

Site Status

Local Institution

Changsha, Hunan, China

Site Status

Local Institution

Nanjing, Jiangsu, China

Site Status

Local Institution - 0002

Changchun, Jilin, China

Site Status

Local Institution - 0006

Dalian, Liaoning, China

Site Status

Local Institution - 0018

Taiyuan, Shan1xi, China

Site Status

Local Institution - 0012

Jingan, Shanghai Municipality, China

Site Status

Local Institution

Chengdu, Sichuan, China

Site Status

Local Institution - 0009

Hangzhou, Zhejiang, China

Site Status

Local Institution - 0003

Hangzhou, Zhejiang, China

Site Status

Local Institution - 0004

Hangzhou, Zhejiang, China

Site Status

Local Institution - 0034

Bucheon-si, , South Korea

Site Status

Local Institution - 0033

Goyang-si, , South Korea

Site Status

Local Institution - 0028

Gwangju, , South Korea

Site Status

Local Institution - 0035

Incheon, , South Korea

Site Status

Local Institution - 0022

Seongnam-si, , South Korea

Site Status

Local Institution - 0037

Seongnam-si, , South Korea

Site Status

Local Institution - 0036

Seoul, , South Korea

Site Status

Local Institution - 0026

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution - 0021

Seoul, , South Korea

Site Status

Local Institution - 0020

Seoul, , South Korea

Site Status

Local Institution - 0027

Seoul, , South Korea

Site Status

Local Institution - 0024

Seoul, , South Korea

Site Status

Local Institution - 0023

Suwon, , South Korea

Site Status

Local Institution - 0029

Kaohsiung City, , Taiwan

Site Status

Local Institution - 0031

Taipei, , Taiwan

Site Status

Local Institution - 0032

Taipei, , Taiwan

Site Status

Local Institution - 0025

Taoyuan District, , Taiwan

Site Status

Countries

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China South Korea Taiwan

References

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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.

Reference Type DERIVED
PMID: 40671612 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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IM011-065

Identifier Type: -

Identifier Source: org_study_id

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