Clinical trial NCT03624127: Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis
Official title: A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-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: 2018-08-09
Enrollment: 666
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 and a currently available treatment in participants with moderate to severe plaque psoriasis.


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

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 or active comparator

Other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)
timeFrame: Week 16
measure: The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)
timeFrame: Baseline and Week 16
Secondary outcomes:
measure: The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score at Week 16 (PASI 90)
timeFrame: Baseline and Week 16
measure: The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 100)
timeFrame: Baseline and Week 16
measure: The Number of Participants With a Static Physician's Global Assessment Score of 0 at Week 16 (sPGA 0)
timeFrame: Week 16
measure: Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16
timeFrame: Baseline and Week 16
measure: Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score 0 at Week 16
timeFrame: Week 16
measure: The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)
timeFrame: Week 16
measure: Number of Participants With a Physician's Global Assessment-Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16
timeFrame: Week 16
measure: The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)
timeFrame: Baseline and Week 16
measure: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)
timeFrame: Week 16
measure: The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)
timeFrame: Week 16
measure: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (sPGA 0/1)
timeFrame: Week 24
measure: The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 75)
timeFrame: Baseline and Week 24
measure: The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)
timeFrame: Baseline and Week 24
measure: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (sPGA 0/1)
timeFrame: Week 52 and Week 24
measure: The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 75)
timeFrame: Baseline, Week 52 and Week 24
measure: The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 52 and at Week 24 (PASI 90)
timeFrame: Baseline, Week 52 and Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research - Mobile
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Tucson
country: United States
facility: Synexus - Tucson
state: Arizona
city: Rogers
country: United States
facility: Hull Dermatology
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley
state: California
city: Irvine
country: United States
facility: University California at Irvine Dermatology Clinical Research Center
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine
state: California
city: Pomona
country: United States
facility: Dream Team Clinical Research
state: California
city: San Diego
country: United States
facility: University Dermatology Group
state: California
city: Sherman Oaks
country: United States
facility: Unison Clinical Trials
state: California
city: Bridgeport
country: United States
facility: New England Research Associates
state: Connecticut
city: Davie
country: United States
facility: Precision Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami
country: United States
facility: LCC Medical Research
state: Florida
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Dermatology
state: Georgia
city: Flossmoor
country: United States
facility: Healthcare Research Network - Flossmoor
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: New Albany
country: United States
facility: The Dermatology Center
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Dermatology
state: Kansas
city: Louisville
country: United States
facility: Dermatology Specialists Research-Kentucky
state: Kentucky
city: Monroe
country: United States
facility: Clinical Trials of America - Monroe
state: Louisiana
city: New Orleans
country: United States
facility: Etre Cosmetic Dermatology and Laser Center
state: Louisiana
city: Beverly
country: United States
facility: ActivMed Practices and Research - Beverly
state: Massachusetts
city: Quincy
country: United States
facility: DermCare Experts
state: Massachusetts
city: Ann Arbor
country: United States
facility: David Fivenson MD Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: New Brighton
country: United States
facility: Associated Skin Care Specialists - Minnesota Clinical Study Center
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: Mount Sinai - Queens
state: New York
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System - Duke Clinic
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: Synexus - Columbus
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading
state: Pennsylvania
city: Anderson
country: United States
facility: Synexus Clinical Research - Anderson
state: South Carolina
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Murfreesboro
country: United States
facility: Interspond - Stones River Dermatology - Murfreesboro Office
state: Tennessee
city: Austin
country: United States
facility: Westlake Dermatology - Westlake
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research - Pflugerville
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Interspond - Acclaim Dermatology
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies - Webster
state: Texas
city: Seattle
country: United States
facility: Dermatology Associates of Seattle
state: Washington
city: Walla Walla
country: United States
facility: Eastern Washington Dermatology
state: Washington
city: Calgary
country: Canada
facility: Kirk Barber Research
state: Alberta
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research
state: Manitoba
city: London
country: Canada
facility: The Guenther Dermatology Research Centre
state: Ontario
city: Newmarket
country: Canada
facility: Office of Dr. Arnon Moshe Katz
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Oakville
country: Canada
facility: Institute of Cosmetic and Laser Surgery
state: Ontario
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology - Richmond Hill
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research
state: Ontario
city: Montreal
country: Canada
facility: Docteur David Gratton Dermatologue
state: Quebec
city: Montreal
country: Canada
facility: Siena Medical Research
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitain
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Wuhan
country: China
facility: Local Institution
state: Hubei
city: Hangzhou
country: China
facility: Local Institution
state: Zhejiang
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Dresden
country: Germany
facility: Klinische Forschung Dresden GmbH
city: Nagoya
country: Japan
facility: Local Institution - 0165
state: Aichi
city: Toon-Shi
country: Japan
facility: Local Institution - 0181
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: Isehara City
country: Japan
facility: Local Institution - 0182
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: National Hospital Organization Yokohama Medical Center
state: Kanagawa
city: Yokohama
country: Japan
facility: Local Institution - 0169
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: Tsu
country: Japan
facility: Mie University Hospital
state: MIE
city: Matsumoto
country: Japan
facility: Local Institution - 0166
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: Teikyo University Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Shinagawa
country: Japan
facility: Local Institution - 0188
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution - 0175
state: Tokyo
city: Shinjuku
country: Japan
facility: Local Institution - 0108
state: Tokyo
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Osaka
country: Japan
facility: Local Institution - 0167
city: Osaka
country: Japan
facility: Local Institution - 0160
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Hwaseong-si
country: Korea, Republic of
facility: Local Institution - 0187
city: Hwaseong-si
country: Korea, Republic of
facility: Local Institution
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Seongnam-si
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution - 0191
state: MZ
city: Bialystok
country: Poland
facility: Local Institution - 0201
city: Gdynia
country: Poland
facility: Local Institution - 0144
city: Katowice
country: Poland
facility: Synexus - Katowice
city: Krak
country: Poland
facility: Local Institution - 0079
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej
city: Lodz
country: Poland
facility: Centrum Medyczne All-Med
city: Olsztyn
country: Poland
facility: Miejski Szpital Zespolony w Olsztynie
city: Osielsko
country: Poland
facility: DermoDent - Centrum Medyczne Czajkowscy
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne
city: Poznan
country: Poland
facility: Local Institution - 0200
city: Warszawa
country: Poland
facility: Clinical Research Group
city: Wroclaw
country: Poland
facility: Center for Clinical Studies - Texas Medical Center
city: Wroclaw
country: Poland
facility: Lukasz Matusiak 4health
city: Wroclaw
country: Poland
facility: dermMedica Sp. z o.o.
city: Wroclaw
country: Poland
facility: Local Institution - 0203
city: Ekaterinburg
country: Russian Federation
facility: Local Institution - 0131
city: Kazan
country: Russian Federation
facility: Azbuka Zdorovya Medical Center
city: Krasnodar
country: Russian Federation
facility: Local Institution - 0172
city: Moscow
country: Russian Federation
facility: Local Institution - 0140
city: Moscow
country: Russian Federation
facility: Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov
city: Ryazan
country: Russian Federation
facility: State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary
city: Saint Petersburg
country: Russian Federation
facility: Clinic of Skin Diseases of Pierre Wolkenstein
city: Saint Petersburg
country: Russian Federation
facility: Polyclinic of Private Security Personnel
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology
city: Saint Petersburg
country: Russian Federation
facility: Ars Vitae Multidisciplinary Medical Center
city: Saratov
country: Russian Federation
facility: Klinika Kozhnykh I Venericheskikh Bolezney
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University
city: Yaroslavl
country: Russian Federation
facility: MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev
city: Alcorcon
country: Spain
facility: Local Institution - 0121
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
city: Barcelona
country: Spain
facility: Hospital del Mar - Parc de Salut Mar
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Valencia
country: Spain
facility: Local Institution - 0097
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Lancashire
country: United Kingdom
facility: MAC Clinical Research - Blackpool
city: Liverpool
country: United Kingdom
facility: Synexus - Merseyside Clinical Research Centre
city: London
country: United Kingdom
facility: Guys and Saint Thomas NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Synexus - Manchester Clinical Research Centre
city: Manchester
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Prescot
country: United Kingdom
facility: MAC Clinical Research - Liverpool
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: