Clinical trial NCT04167462: 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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-11-18
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The Percentage of Participants With sPGA Response of 0 or 1
timeFrame: At week 16
measure: The Percentage of Participants With PASI 75 Response
timeFrame: At week 16
Secondary outcomes:
measure: The Percentage of Participants With PASI 90 Response
timeFrame: At week 16
measure: The Percentage of Participants With PASI 100 Response
timeFrame: At week 16
measure: The Percentage of Participants With sPGA 0 Response
timeFrame: At week 16
measure: Change From Baseline in PSSD Symptom Score
timeFrame: Baseline and at Week 16
measure: The Percentage of Participants With Ss-PGA Score of 0 or 1
timeFrame: At week 16
measure: The Percentage of Participants With DLQI Score of 0 or 1
timeFrame: At week 16
measure: The Percentage of Participants With PGA-F Score of 0 or 1
timeFrame: At week 16
measure: The Percentage of Participants With PSSD Symptom Score of 0
timeFrame: At week 16
measure: The Percentage of Participants With Pp-PGA Score of 0 or 1
timeFrame: At week 16
measure: The Percentage of Participants With PASI 75 Response at Week 52
timeFrame: At week 52
measure: The Percentage of Participants With sPGA Response of 0 or 1 at Week 52
timeFrame: At week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution - 0001
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0007
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0014
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0008
state: Chongqing
city: Wuhan
country: China
facility: Local Institution - 0011
state: Hubei
city: Wuhan
country: China
facility: Local Institution - 0016
state: Hubei
city: Changsha
country: China
facility: Local Institution
state: Hunan
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Changchun
country: China
facility: Local Institution - 0002
state: Jilin
city: Dalian
country: China
facility: Local Institution - 0006
state: Liaoning
city: Taiyuan
country: China
facility: Local Institution - 0018
state: Shan1xi
city: Jingan
country: China
facility: Local Institution - 0012
state: Shanghai
city: Chengdu
country: China
facility: Local Institution
state: Sichuan
city: Hangzhou
country: China
facility: Local Institution - 0009
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0003
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0004
state: Zhejiang
city: Bucheon-si
country: Korea, Republic of
facility: Local Institution - 0034
city: Goyang-si
country: Korea, Republic of
facility: Local Institution - 0033
city: Gwangju
country: Korea, Republic of
facility: Local Institution - 0028
city: Incheon
country: Korea, Republic of
facility: Local Institution - 0035
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0022
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution - 0037
city: Seoul.
country: Korea, Republic of
facility: Local Institution - 0020
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0036
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0026
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0021
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0027
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0024
city: Suwon
country: Korea, Republic of
facility: Local Institution - 0023
city: Kaohsiung
country: Taiwan
facility: Local Institution - 0029
city: Taipei
country: Taiwan
facility: Local Institution - 0031
city: Taipei
country: Taiwan
facility: Local Institution - 0032
city: Taoyuan
country: Taiwan
facility: Local Institution - 0025
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: