Clinical trial NCT03924427: An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis
Official title: An Open-Label, Single-arm, Multi-Center, Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Japanese Subjects With Moderate-to-Severe Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-04-23
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate BMS-986165 given to Japanese participants with moderate-to-severe psoriasis.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

a. For participants with plaque psoriasis: i. Stable plaque psoriasis for at least 6 months ii. Moderate to severe disease iii. Candidate for phototherapy or systemic therapy b. Additional protocol-specified inclusion criteria apply for subjects with psoriatic arthritis, erythrodermic psoriasis, or generalized pustular psoriasis

Exclusion Criteria:

1. Guttate, inverse, or drug-induced psoriasis at Screening or Baseline
2. History of recent infection
3. Prior exposure to BMS-986165

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Static Physician's Global Assessment (sPGA) 0/1 Response as a Number of Participants With a sPGA Score of 0 or 1 at Week 16
timeFrame: Week 16
measure: Psoriasis Area and Severity Index (PASI) 75 Response Assessed as a Number of Participants Who Achieve a 75% Improvement From Baseline in the PASI Score at Week 16
timeFrame: Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Local Institution - 0014
state: Aichi
city: Toon-Shi
country: Japan
facility: Local Institution
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: University of Occupational and Environmental Health, Japan
state: Fukuoka
city: Sapporo
country: Japan
facility: Sapporo Skin Clinic
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Morioka
country: Japan
facility: Local Institution
state: Iwate
city: Isehara City
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: National Hospital Organization Yokohama Medical Center
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Nakoku
country: Japan
facility: Kochi Medical School Hospital
state: Kochi
city: Kyoto-city
country: Japan
facility: University Hospital - Kyoto Preferctural University of Medicine
state: Kyoto
city: Kyoto-City
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Tsu
country: Japan
facility: Mie University Hospital
state: MIE
city: Matsumoto
country: Japan
facility: Local Institution - 0004
state: Nagano
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Itabashi
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Shinagawa
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Shinjuku
country: Japan
facility: Japan Community Health Care Organization Tokyo Yamate Medical Center
state: Tokyo
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Osaka
country: Japan
facility: Local Institution - 0003
city: Osaka
country: Japan
facility: Local Institution - 0012
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: