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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT04167462

Collaborator

(none)

220

Enrollment

Locations

Arms

25.4

Actual Duration (Months)

6.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: BMS-986165 Other: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 25, 2019

Actual Primary Completion Date :

Mar 8, 2021

Actual Study Completion Date :

Jan 7, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

static Physician Global Assessment (sPGA) 0/1 response [Baseline to Week 16]
Psoriasis Area and Severity Index (PASI) 75 response [Baseline to Week 16]

Secondary Outcome Measures

PASI 90,100 [at 16 weeks]
sPGA 0 [at 16 weeks]
scalp specific Physician's Global Assessment (ss-PGA) 0/1 response [at 16 weeks]
Change from baseline in Psoriasis Symptoms and Signs Diary (PSSD) symptom score [at 16 weeks]
PSSD symptom score of 0 assessed as a proportion of participants with a PSSD symptom score of 0 among participants with a baseline PSSD symptom score ≥1 [at 16 weeks]
Change from baseline in PSSD sign score [at 16 weeks]
PSSD sign score of 0 assessed as a proportion of subjects with a PSSD sign score of 0 among subjects with a baseline PSSD sign score ≥1 [at 16 weeks]
Physician Global Assessment- Fingernails (PGA-F) 0/1 [at 16 weeks]
Dermatology Life Quality Index (DLQI) 0/1 assessed as a proportion of participants with a DLQI score of 0 or 1 among participants with a baseline DLQI score ≥2 [at 16 weeks]
Change from baseline in DLQI score [at 16 weeks]
Palmoplantar PGA (pp-PGA) 0/1 assessed as a proportion of participants with a pp-PGA score of 0 or 1 among participants with a baseline pp-PGA score ≥3 [at 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Beijing	Beijing	China	100044
2	Local Institution	Beijing	Beijing	China	100050
3	Local Institution	Beijing	Beijing	China	100069
4	Local Institution	Chongqing	Chongqing	China	630014
5	Local Institution	Wuhan	Hubei	China	430022
6	Local Institution	Wuhan	Hubei	China	430030
7	Local Institution	Changsha	Hunan	China	410011
8	Local Institution	Nanjing	Jiangsu	China	210029
9	Local Institution	Changchun	Jilin	China	130021
10	Local Institution	Dalian	Liaoning	China	116011
11	Local Institution	Taiyuan	Shan1xi	China	030001
12	Local Institution	Jingan	Shanghai	China	200443
13	Local Institution	Chengdu	Sichuan	China	610041
14	Local Institution	Hangzhou	Zhejiang	China	310003
15	Local Institution	Hangzhou	Zhejiang	China	310014
16	Local Institution	Hangzhou	Zhejiang	China	310016
17	Local Institution	Bucheon-si		Korea, Republic of	14584
18	Local Institution	Goyang-si		Korea, Republic of	10380
19	Local Institution	Gwangju		Korea, Republic of	61469
20	Local Institution	Incheon		Korea, Republic of	21565
21	Local Institution	Seongnam-si		Korea, Republic of	13496
22	Local Institution	Seongnam-si		Korea, Republic of	13620
23	Local Institution	Seoul.		Korea, Republic of	06973
24	Local Institution	Seoul		Korea, Republic of	02447
25	Local Institution	Seoul		Korea, Republic of	03722
26	Local Institution	Seoul		Korea, Republic of	05030
27	Local Institution	Seoul		Korea, Republic of	110-774
28	Local Institution	Seoul		Korea, Republic of	137-701
29	Local Institution	Seoul		Korea, Republic of	152-703
30	Local Institution	Suwon		Korea, Republic of	16499
31	Local Institution	Kaohsiung		Taiwan	83301
32	Local Institution	Taipei		Taiwan	10002
33	Local Institution	Taipei		Taiwan	11490
34	Local Institution	Taoyuan		Taiwan	33305

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT04167462

Other Study ID Numbers:

IM011-065

First Posted:

Nov 18, 2019

Last Update Posted:

Mar 8, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Psoriasis

BMS-986165

Study Results

No Results Posted as of Mar 8, 2022