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
NCT ID: NCT03611751
Last Updated: 2022-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1020 participants
INTERVENTIONAL
2018-07-26
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMS-986165
BMS-986165 oral administration
BMS-986165
Specified dose on specified days
Placebo
Placebo oral administration
Placebo
Specified dose on specified days
Active comparator
Active comparator oral administration
Apremilast
Specified dose on specified days
Interventions
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BMS-986165
Specified dose on specified days
Placebo
Specified dose on specified days
Apremilast
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe disease
* Candidate for phototherapy or systemic therapy
Exclusion Criteria
* History of recent infection
* Prior exposure to BMS-986165 or active comparator
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Total Skin and Beauty Dermatology Center
Birmingham, Alabama, United States
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States
Alliance Dermatology and Mohs Center - Phoenix
Phoenix, Arizona, United States
Clinical Research Consortium - Tempe
Tempe, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Anaheim Clinical Trials
Anaheim, California, United States
Center for Dermatology Clinical Research
Fremont, California, United States
Associates in Research, Inc.
Fresno, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Interspond - Long Beach Clinical Trials
Long Beach, California, United States
Dermatology Research Associates - Los Angeles
Los Angeles, California, United States
LA Universal Research Center
Los Angeles, California, United States
Artemis Institute for Clinical Research - San Diego
San Diego, California, United States
University of California San Diego Health Systems
San Diego, California, United States
Therapeutics Clinical Research
San Diego, California, United States
San Luis Dermatology and Laser Clinic
San Luis Obispo, California, United States
Artemis Institute for Clinical Research - San Marcos
San Marcos, California, United States
West Coast Research
San Ramon, California, United States
Clinical Science Institute
Santa Monica, California, United States
Synexus - Santa Rosa
Santa Rosa, California, United States
Care Access Research - Walnut Creek
Walnut Creek, California, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Skin Care Research
Boca Raton, Florida, United States
ERN - Accel Research - Avail
DeLand, Florida, United States
Interspond - Savin Medical Group
Miami Lakes, Florida, United States
Synexus Clinical Research - Saint Petersburg
Pinellas Park, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Precision Clinical Research - Corporate Office
Sunrise, Florida, United States
Precision Clinical Research - Corporate Office
Tamarac, Florida, United States
Moore Clinical Research - South Tampa
Tampa, Florida, United States
University of South Florida/USF Health
Tampa, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Marietta Dermatology & The Skin Cancer Center
Marietta, Georgia, United States
Advanced Clinical Research - Idaho
Meridian, Idaho, United States
Glazer Dermatology
Buffalo Grove, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
Dermatology Center of Northwest Indiana
Crown Point, Indiana, United States
Synexus - Evansville South
Evansville, Indiana, United States
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, United States
Skin Sciences
Louisville, Kentucky, United States
Advanced Medical Research
Lacombe, Louisiana, United States
Shondra L. Smith, M.D.
Lake Charles, Louisiana, United States
DelRicht Research - New Orleans - Prytania Street
New Orleans, Louisiana, United States
Ora
Andover, Massachusetts, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham Dermatology Associates
Boston, Massachusetts, United States
A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Washington University School of Medicine - West County Dermatology
Creve Coeur, Missouri, United States
Healthcare Research Network - Hazelwood
Hazelwood, Missouri, United States
Clinical Research Consortium - Las Vegas
Las Vegas, Nevada, United States
ActivMed Practices and Research - Portsmouth
Portsmouth, New Hampshire, United States
Windsor Dermatology
East Windsor, New Jersey, United States
Sadick Research Group
New York, New York, United States
DermResearch Center of New York
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
PMG Research of Cary
Cary, North Carolina, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Synexus - Cincinnati
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
ClinOhio Research Services
Columbus, Ohio, United States
Wright State Research Institute
Fairborn, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Dermatology and Skin Surgery Center - Exton
Exton, Pennsylvania, United States
Paddington Testing Company
Philadelphia, Pennsylvania, United States
Synexus
Greer, South Carolina, United States
Coastal Carolina Research Center - Mount Pleasant
Mt. Pleasant, South Carolina, United States
Health Concepts
Rapid City, South Dakota, United States
Rivergate Dermatology - Main Office
Goodlettsville, Tennessee, United States
Clinical Research Solutions - Jackson
Jackson, Tennessee, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
The Skin Wellness Center
Knoxville, Tennessee, United States
Arlington Center for Dermatology
Arlington, Texas, United States
DermResearch
Austin, Texas, United States
Bellaire Dermatology
Bellaire, Texas, United States
Modern Research Associates
Dallas, Texas, United States
Synexus - Dallas
Dallas, Texas, United States
Progressive Clinical Research - San Antonio
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Interspond - Houston Center for Clinical Research
Sugar Land, Texas, United States
West Virginia University
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Woden Dermatology
Phillip, Australian Capital Territory, Australia
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia
St. George Dermatology & Skin Care Centre
Kogarah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
North Eastern Health Specialists
Hectorville, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Skin and Cancer Foundation
Carlton, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
Institute for Skin Advancement
Calgary, Alberta, Canada
Stratica Medical
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
CCA Medical Research
Ajax, Ontario, Canada
Mediprobe Research
London, Ontario, Canada
DermEffects
London, Ontario, Canada
Lynderm Research
Markham, Ontario, Canada
DermEdge
Mississauga, Ontario, Canada
York Dermatology Clinic and Research Centre
Mississauga, Ontario, Canada
Office of Dr. Niakosari Firouzeh
North York, Ontario, Canada
Dermatology Ottawa Research Centre
Ottawa, Ontario, Canada
Toronto Dermatology Centre
Toronto, Ontario, Canada
Dermatology on Bloor
Toronto, Ontario, Canada
Kim Papp Clinical Research
Waterloo, Ontario, Canada
Dr. Isabelle Delorme
Drummondville, Quebec, Canada
Innovaderm Research
Montreal, Quebec, Canada
Nemocnice Jihlava
Jihlava, , Czechia
Nemocnice Novy Jicin a.s.
Nový Jičín, , Czechia
MUDr. Helena Korandova
Olomouc, , Czechia
Fakultni Nemocnice Ostrava
Ostrava, , Czechia
Clintrial
Prague, , Czechia
Sanatorium profesora Arenbergera
Prague, , Czechia
Kozni a zilni ambulance
Ústí nad Labem, , Czechia
Krajska zdravotni - Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, , Czechia
Terveystalo Tampere
Tampere, , Finland
Mehilainen Turku
Turku, , Finland
Local Institution - 0197
Vaasa, , Finland
Hopital Prive dAntony
Antony, , France
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
Brest, , France
Centre Hospitalier Universitaire de Nice Hopital lArchet
Nice, , France
Centre Hospitalier Universitaire de Toulouse- Hopital Larrey
Toulouse, , France
Local Institution - 0128
Augsburg, , Germany
Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus
Bochum, , Germany
Hautarztpraxis Dr. Beatrice Gerlach
Dresden, , Germany
Local Institution - 0246
Frankfurt am Main, , Germany
Local Institution - 0119
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Dermakiel - Allergie Und Haut Centrum
Kiel, , Germany
Praxis Dr. Beate Schwarz
Langenau, , Germany
Universitatsklinikum Schleswig-Holstein - Campus Lubeck
Lübeck, , Germany
Klinikum rechts der Isar der Technischen Universitat Munchen Klinik und Poliklinik fur Dermatolog
München, , Germany
Harzklinikum Dorothea Christiane Erxleben
Quedlinburg, , Germany
Praxis Dr. med. Wilfried Steinborn
Straubing, , Germany
CentroDerm GmbH
Wuppertal, , Germany
Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.
Budapest, , Hungary
Synexus Magyarorszag
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft. - Affiliated Site Gyula
Gyula, , Hungary
Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat
Nyíregyháza, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
Szegedi Tudomanyegyetem
Szeged, , Hungary
Allergo-Derm Bakos
Szolnok, , Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg
Zalaegerszeg, , Hungary
Local Institution
Haifa, , Israel
Local Institution
Kfar Saba, , Israel
Local Institution
Petah Tikva, , Israel
Local Institution
Ramat Gan, , Israel
Azienda Ospedaliero Universitaria di Bologna Policlinico SantOrsola-Malpighi
Bologna, , Italy
Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
Pisa, , Italy
Local Institution
Hamilton, , New Zealand
Local Institution
Mount Cook, , New Zealand
Local Institution
Tauranga, , New Zealand
ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, , Poland
ClinicMed Daniluk Nowak Spolka Jawna
Bialystok, , Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Synexus Polska Oddzial w Gdansk
Gda?sk, , Poland
Zespol Naukowo-Leczniczy Iwolang
Iwonicz-Zdrój, , Poland
Krakowskie Centrum Medyczne
Krakow, , Poland
Dermed Centrum Medyczne
Lodz, , Poland
Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak
Lodz, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER
Lublin, , Poland
ETG - Siedlce
Siedlce, , Poland
ETG - Skierniewice
Skierniewice, , Poland
Local Institution - 0142
Torun, , Poland
High-Med Przychodnia Specjalistyczna
Warsaw, , Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, , Poland
ETG - Warszawa
Warsaw, , Poland
Klinika Ambroziak
Warsaw, , Poland
Local Institution - 0183
Wroclaw, , Poland
GCM Medical Group
San Juan, , Puerto Rico
Local Institution - 0156
Córdoba, , Spain
Hospital Universitario de Vinalopo
Elche, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital de Manises
Manises, , Spain
Hospital Universitario Virgen de la Victoria
Mߧa, , Spain
Local Institution - 0137
Pozuelo de Alarcón, , Spain
Burbage Surgery
Santiago de Compostela, , Spain
Consorci Hospital General Universitari de Valencia
Valencia, , Spain
Ladulaas Kliniska Studier
Borås, , Sweden
Pharmasite - Helsingborg
Helsingborg, , Sweden
ProbarE i Lund
Lund, , Sweden
PharmaSite - Malmo
Malmo, , Sweden
Karolinska Universitetssjukhuset
Solna, , Sweden
MAC Clinical Research - Cannock
Cannock, , United Kingdom
Ashgate Medical Practice
Chesterfield, , United Kingdom
Local Institution - 0189
Chorley, , United Kingdom
Mounts Bay Medical
Cornwall, , United Kingdom
The Dudley Group NHS Foundation Trust
Dudley, , United Kingdom
MAC Clinical Research - Stockton
Durham, , United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
MAC Clinical Research - Manchester
Manchester, , United Kingdom
Countries
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References
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Merola JF, Mease PJ, Armstrong AW, Strand V, Lehman T, Varga S, Choi JC, Becker B, Zhong Y, Colombo MJ, Thaci D, Bili A, Gottlieb AB. Deucravacitinib in Patients with Plaque Psoriasis Who Screened Positive for Psoriatic Arthritis: Improvements in Joint Pain and the Impact of Musculoskeletal Symptoms. Dermatol Ther (Heidelb). 2025 Aug;15(8):2281-2293. doi: 10.1007/s13555-025-01428-9. Epub 2025 May 30.
Armstrong AW, Kircik L, Stein Gold L, Strober B, De Oliveira CHMC, Vaile J, Jou YM, Daamen C, Scharnitz T, Lebwohl M. Deucravacitinib: Laboratory Parameters Across Phase 3 Plaque Psoriasis Trials. Dermatol Ther (Heidelb). 2025 Apr;15(4):1025-1035. doi: 10.1007/s13555-025-01362-w. Epub 2025 Mar 20.
Armstrong AW, Lebwohl M, Warren RB, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp KA, Kisa RM, Vaile J, Berger V, Vritzali E, Hoyt K, Colombo MJ, Scotto J, Banerjee S, Strober B, Thaci D, Blauvelt A. Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials. JAMA Dermatol. 2025 Jan 1;161(1):56-66. doi: 10.1001/jamadermatol.2024.4688.
Armstrong AW, Augustin M, Beaumont JL, Pham TP, Hudgens S, Gordon KB, Zhuo J, Becker B, Zhong Y, Kisa RM, Banerjee S, Papp KA. Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials. Dermatol Ther (Heidelb). 2024 Aug;14(8):2235-2248. doi: 10.1007/s13555-024-01224-x. Epub 2024 Jul 30.
Strober B, Thaci D, Sofen H, Kircik L, Gordon KB, Foley P, Rich P, Paul C, Bagel J, Colston E, Throup J, Kundu S, Sekaran C, Linaberry M, Banerjee S, Papp KA. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-2 study): a plain language summary. Immunotherapy. 2023 Aug;15(11):787-797. doi: 10.2217/imt-2023-0062. Epub 2023 May 7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2018-001925-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM011-047
Identifier Type: -
Identifier Source: org_study_id