Clinical trial NCT03611751: An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
Official title: A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study With Randomized Withdrawal and Retreatment 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: 2018-08-02
Enrollment: 1020
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 could 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 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 Score at Week 16 (PASI 100)
timeFrame: Baseline and Week 16
measure: The Number of Participants With a Static Physician 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 at Week 16
timeFrame: Baseline and Week 16
measure: Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16
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 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: The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)
timeFrame: Week 16
measure: The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 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 Apremilast at Week 16 (PASI 75)
timeFrame: Baseline and Week 16
measure: The Number of Participants With a Static Physician 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: Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders
timeFrame: From Week 24 to Week 52 (up to approximately 28 weeks)
measure: The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist 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 Apremalist 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 Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)
timeFrame: Baseline and week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center
state: Alabama
city: Birmingham
country: United States
facility: The Kirklin Clinic of UAB Hospital
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology and Mohs Center - Phoenix
state: Arizona
city: Tempe
country: United States
facility: Clinical Research Consortium - Tempe
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research
state: California
city: Fresno
country: United States
facility: Associates in Research, Inc.
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Long Beach
country: United States
facility: Interspond - Long Beach Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates - Los Angeles
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research - San Diego
state: California
city: San Diego
country: United States
facility: University of California San Diego Health Systems
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Luis Obispo
country: United States
facility: San Luis Dermatology and Laser Clinic
state: California
city: San Marcos
country: United States
facility: Artemis Institute for Clinical Research - San Marcos
state: California
city: San Ramon
country: United States
facility: West Coast Research
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Santa Rosa
country: United States
facility: Synexus - Santa Rosa
state: California
city: Walnut Creek
country: United States
facility: Care Access Research - Walnut Creek
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Boca Raton
country: United States
facility: Skin Care Research
state: Florida
city: DeLand
country: United States
facility: ERN - Accel Research - Avail
state: Florida
city: Miami Lakes
country: United States
facility: Interspond - Savin Medical Group
state: Florida
city: Pinellas Park
country: United States
facility: Synexus Clinical Research - Saint Petersburg
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research - Corporate Office
state: Florida
city: Tamarac
country: United States
facility: Precision Clinical Research - Corporate Office
state: Florida
city: Tampa
country: United States
facility: Moore Clinical Research - South Tampa
state: Florida
city: Tampa
country: United States
facility: University of South Florida/USF Health
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Marietta
country: United States
facility: Marietta Dermatology & The Skin Cancer Center
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research - Idaho
state: Idaho
city: Buffalo Grove
country: United States
facility: Glazer Dermatology
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Crown Point
country: United States
facility: Dermatology Center of Northwest Indiana
state: Indiana
city: Evansville
country: United States
facility: Synexus - Evansville South
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Dermatology Group
state: Indiana
city: Louisville
country: United States
facility: Skin Sciences
state: Kentucky
city: Lacombe
country: United States
facility: Advanced Medical Research
state: Louisiana
city: Lake Charles
country: United States
facility: Shondra L. Smith, M.D.
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research - New Orleans - Prytania Street
state: Louisiana
city: Andover
country: United States
facility: Ora
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham Dermatology Associates
state: Massachusetts
city: Ann Arbor
country: United States
facility: A. Alfred Taubman Health Care Center
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Creve Coeur
country: United States
facility: Washington University School of Medicine - West County Dermatology
state: Missouri
city: Hazelwood
country: United States
facility: Healthcare Research Network - Hazelwood
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Research Consortium - Las Vegas
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices and Research - Portsmouth
state: New Hampshire
city: East Windsor
country: United States
facility: Windsor Dermatology
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Stony Brook
country: United States
facility: DermResearch Center of New York
state: New York
city: Cary
country: United States
facility: PMG Research of Cary
state: North Carolina
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Cincinnati
country: United States
facility: Synexus - Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: ClinOhio Research Services
state: Ohio
city: Fairborn
country: United States
facility: Wright State Research Institute
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Exton
country: United States
facility: Dermatology and Skin Surgery Center - Exton
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Company
state: Pennsylvania
city: Greer
country: United States
facility: Synexus
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center - Mount Pleasant
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Goodlettsville
country: United States
facility: Rivergate Dermatology - Main Office
state: Tennessee
city: Jackson
country: United States
facility: Clinical Research Solutions - Jackson
state: Tennessee
city: Knoxville
country: United States
facility: Dermatology Associates of Knoxville
state: Tennessee
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Austin
country: United States
facility: DermResearch
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Dallas
country: United States
facility: Synexus - Dallas
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research - San Antonio
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Interspond - Houston Center for Clinical Research
state: Texas
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Phillip
country: Australia
facility: Woden Dermatology
state: Australian Capital Territory
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Kogarah
country: Australia
facility: St. George Dermatology & Skin Care Centre
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Hectorville
country: Australia
facility: North Eastern Health Specialists
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Carlton
country: Australia
facility: Skin and Cancer Foundation
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology
state: Western Australia
city: Calgary
country: Canada
facility: Institute for Skin Advancement
state: Alberta
city: Edmonton
country: Canada
facility: Stratica Medical
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: London
country: Canada
facility: Mediprobe Research
state: Ontario
city: London
country: Canada
facility: DermEffects
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge
state: Ontario
city: Mississauga
country: Canada
facility: York Dermatology Clinic and Research Centre
state: Ontario
city: North York
country: Canada
facility: Office of Dr. Niakosari Firouzeh
state: Ontario
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Dermatology Centre
state: Ontario
city: Toronto
country: Canada
facility: Dermatology on Bloor
state: Ontario
city: Waterloo
country: Canada
facility: Kim Papp Clinical Research
state: Ontario
city: Drummondville
country: Canada
facility: Dr. Isabelle Delorme
state: Quebec
city: Montreal
country: Canada
facility: Innovaderm Research
state: Quebec
city: Jihlava 1
country: Czechia
facility: Nemocnice Jihlava
city: Novy Jicin
country: Czechia
facility: Nemocnice Novy Jicin a.s.
city: Olomouc
country: Czechia
facility: MUDr. Helena Korandova
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Praha 10
country: Czechia
facility: Clintrial
city: Praha 1
country: Czechia
facility: Sanatorium profesora Arenbergera
city: Usti nad Labem
country: Czechia
facility: Kozni a zilni ambulance
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
city: Tampere
country: Finland
facility: Terveystalo Tampere
city: Turku
country: Finland
facility: Mehilainen Turku
city: Vaasa
country: Finland
facility: Local Institution - 0197
city: Antony
country: France
facility: Hopital Prive dAntony
city: Brest Cedex
country: France
facility: Centre Hospitalier Regional Universitaire Brest Hopital Morvan
city: Nice Cedex 3
country: France
facility: Centre Hospitalier Universitaire de Nice Hopital lArchet
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse- Hopital Larrey
city: Augsburg
country: Germany
facility: Local Institution - 0128
city: Bochum
country: Germany
facility: Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
city: Dresden
country: Germany
facility: Hautarztpraxis Dr. Beatrice Gerlach
city: Frankfurt am Main
country: Germany
facility: Local Institution - 0246
city: Hamburg
country: Germany
facility: Local Institution - 0119
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Dermakiel - Allergie Und Haut Centrum
city: Langenau
country: Germany
facility: Praxis Dr. Beate Schwarz
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein - Campus Lubeck
city: Munchen
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog
city: Quedlinburg
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben
city: Straubing
country: Germany
facility: Praxis Dr. med. Wilfried Steinborn
city: Wuppertal
country: Germany
facility: CentroDerm GmbH
city: Budapest
country: Hungary
facility: Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
city: Budapest
country: Hungary
facility: Synexus Magyarorszag
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyula
country: Hungary
facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos
city: Zalaegerszeg
country: Hungary
facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg
city: Haifa
country: Israel
facility: Local Institution
city: Kfar Saba
country: Israel
facility: Local Institution
city: Petah Tikva
country: Israel
facility: Local Institution
city: Ramat Gan
country: Israel
facility: Local Institution
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
city: Hamilton
country: New Zealand
facility: Local Institution
city: Mount Cook
country: New Zealand
facility: Local Institution
city: Tauranga
country: New Zealand
facility: Local Institution
city: Bialystok
country: Poland
facility: ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
city: Bialystok
country: Poland
facility: ClinicMed Daniluk Nowak Spolka Jawna
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
city: Gda?sk
country: Poland
facility: Synexus Polska Oddzial w Gdansk
city: Iwonicz-Zdroj
country: Poland
facility: Zespol Naukowo-Leczniczy Iwolang
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne
city: Lodz
country: Poland
facility: Dermed Centrum Medyczne
city: Lodz
country: Poland
facility: Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
city: Lublin
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER
city: Siedlce
country: Poland
facility: ETG - Siedlce
city: Skierniewice
country: Poland
facility: ETG - Skierniewice
city: Torun
country: Poland
facility: Local Institution - 0142
city: Warsaw
country: Poland
facility: Klinika Ambroziak
city: Warszawa
country: Poland
facility: High-Med Przychodnia Specjalistyczna
city: Warszawa
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
city: Warszawa
country: Poland
facility: ETG - Warszawa
city: Wroclaw
country: Poland
facility: Local Institution - 0183
city: San Juan
country: Puerto Rico
facility: GCM Medical Group
city: Cordoba
country: Spain
facility: Local Institution - 0156
city: Elche
country: Spain
facility: Hospital Universitario de Vinalopo
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrin
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Manises
country: Spain
facility: Hospital de Manises
city: Mߧa
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Pozuelo de Alarcon
country: Spain
facility: Local Institution - 0137
city: Santiago de Compostela
country: Spain
facility: Burbage Surgery
city: Valencia
country: Spain
facility: Consorci Hospital General Universitari de Valencia
city: Boras
country: Sweden
facility: Ladulaas Kliniska Studier
city: Helsingborg
country: Sweden
facility: Pharmasite - Helsingborg
city: Lund
country: Sweden
facility: ProbarE i Lund
city: Malmo
country: Sweden
facility: PharmaSite - Malmo
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Cannock
country: United Kingdom
facility: MAC Clinical Research - Cannock
city: Chesterfield
country: United Kingdom
facility: Ashgate Medical Practice
city: Chorley
country: United Kingdom
facility: Local Institution - 0189
city: Cornwall
country: United Kingdom
facility: Mounts Bay Medical
city: Dudley
country: United Kingdom
facility: The Dudley Group NHS Foundation Trust
city: Durham
country: United Kingdom
facility: MAC Clinical Research - Stockton
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust
city: Manchester
country: United Kingdom
facility: MAC Clinical Research - Manchester
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: