Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)
NCT ID: NCT03881059
Last Updated: 2022-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
203 participants
INTERVENTIONAL
2019-04-01
2021-01-27
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
DOUBLE
Study Groups
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Part A: Placebo
BMS-986165 Placebo
Participants will receive BMS-986165 matching placebo QD
Part A: BMS-986165 Dose A
BMS-986165 Dose A
Participants will receive BMS-986165 Dose A QD.
Part A: BMS-986165 Dose B
BMS-986165 Dose B
Participants will receive BMS-986165 dose B QD.
Part B: Ustekinumab + BMS-986165 Placebo
BMS-986165 Placebo
Participants will receive BMS-986165 matching placebo QD
Ustekinumab
Participants will receive ustekinumab SQ injection QD.
Part B: BMS-986165 Dose A + Ustekinumab Placebo
BMS-986165 Dose A
Participants will receive BMS-986165 Dose A QD.
Ustekinumab Placebo
Participants will receive ustekinumab SQ matching placebo QD
Part B: BMS-986165 Dose B + Ustekinumab Placebo
BMS-986165 Dose B
Participants will receive BMS-986165 dose B QD.
Ustekinumab Placebo
Participants will receive ustekinumab SQ matching placebo QD
Interventions
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BMS-986165 Placebo
Participants will receive BMS-986165 matching placebo QD
BMS-986165 Dose A
Participants will receive BMS-986165 Dose A QD.
BMS-986165 Dose B
Participants will receive BMS-986165 dose B QD.
Ustekinumab
Participants will receive ustekinumab SQ injection QD.
Ustekinumab Placebo
Participants will receive ustekinumab SQ matching placebo QD
Eligibility Criteria
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Inclusion Criteria
* Participants either (i) cannot have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 tumor necrosis factor -inhibitor (TNFi) (TNFi-experienced). Failure is defined as lack of response or loss of response with at least 3 months of therapy with an approved dose of a TNFi, as judged by the investigator. Failure must have occurred at least 2 months prior to Day 1
* Participants have at least 1 confirmed greater than or equal to (\>=) 2 centimeter (cm) lesion of plaque psoriasis at screening
* Participants have active arthritis as shown by a minimum of \>= 3 swollen joints and \>= 3 tender joints (66/68 joint counts) at screening and Day 1
* High sensitivity C-reactive protein (hsCRP) \>= 3milligram per liter (mg/L) at screening
* Women of Childbearing Potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment
Exclusion Criteria
* Has any other autoimmune condition such as rheumatoid arthritis, etc. There are exceptions for inflammatory bowel disease or uveitis as follows: currently active disease is excluded but, a history of no longer active disease for at least 12 months (including not being on medication) is allowed
* Has active (i.e. currently symptomatic) fibromyalgia
* History or evidence of active infection and/or febrile illness within 7 days prior to Day 1 (example, bronchopulmonary, urinary, gastrointestinal, etc.)
* History of recent serious bacterial, fungal, or viral infections requiring hospitalization and intravenous (IV) antimicrobial treatment within 90 days prior to screening, or any infection requiring antimicrobial treatment within 15 days prior to Day 1
* History of active tuberculosis (TB) prior to screening visit, regardless of completion of adequate treatment
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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Rheumatology Associates of North Alabama
Huntsville, Alabama, United States
Medvin Clinical Research - Covina Office
Covina, California, United States
University of California at San Diego Medical Center
La Jolla, California, United States
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States
San Marcus Research Clinic
Miami Lakes, Florida, United States
Omega Research Consultants - Metrowest
Orlando, Florida, United States
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States
BayCare Medical Group
St. Petersburg, Florida, United States
University of South Florida - Morsani College of Medicine
Tampa, Florida, United States
Heartland Research Associates - East Wichita
Wichita, Kansas, United States
Arthritis Center of Lexington
Lexington, Kentucky, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Arthritis Associates
Hattiesburg, Mississippi, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Atlantic Coast Rheumatology
Toms River, New Jersey, United States
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, United States
The Center for Rheumatology-Albany
Albany, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Joint Muscle Medical Care and Research Institute - Lilington Office
Charlotte, North Carolina, United States
DJL Clinical Research
Charlotte, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Paramount Medical Research and Consulting
Middleburg Heights, Ohio, United States
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Low Country Rheumatology
Summerville, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Office of Ramesh C. Gupta, MD
Memphis, Tennessee, United States
Pioneer Research Solutions
Cypress, Texas, United States
Southwest Rheumatology Research
Mesquite, Texas, United States
Seattle Rheumatology Associates
Seattle, Washington, United States
Arthritis Northwest Rheumatology
Spokane, Washington, United States
L.K.N. Arthrocentrum, s.r.o
Hlu?, , Czechia
CCR Ostrava
Ostrava, , Czechia
Revmatologie MUDr. Klara Sirova s.r.o.
Ostrava, , Czechia
Arthrocentrum
Prague, , Czechia
Revmatologicky Ustav
Prague, , Czechia
CCR Prague
Prague, , Czechia
Nuselska Poliklinika
Prague, , Czechia
Affidea Praha
Praha 11 Chodov, , Czechia
PV-Medical Services, s.r.o.
Zlín, , Czechia
Charite Universitatsmedizin Berlin
Berlin, , Germany
Rheumatologische Schwerpunktpraxis PD Dr. med. Brandt Jurgens
Berlin, , Germany
Universitatsklinikum Erlangen
Erlangen, , Germany
Universitatsklinikum Frankfurt
Frankfurt am Main, , Germany
HRF II - Hamburger Rheuma Forschungszentrum II - MVZ fur Rheumatologie und Autoimmunmedizin Hamburg
Hamburg, , Germany
SMO.MD GmbH
Magdeburg, , Germany
Universitatsmedizin Mannheim
Mannheim, , Germany
Klinikum der Universitat Munchen
München, , Germany
Clinexpert Gyogycentrum
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
CRU Hungary Egeszsegugyi es Szolgaltato Korlatolt Felelossegu Tarsasag
Miskolc, , Hungary
Aranyklinika
Szeged, , Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes, , Hungary
CMed Rehabilitacios es Diagnosztikai Kozpont
Székesfehérvár, , Hungary
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, , Italy
Osteo-Medic
Bia?ystok, , Poland
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, , Poland
ClinicMed Daniluk Nowak Spolka Jawna
Bialystok, , Poland
Nasz Lekarz Osrodek Badan Klinicznych - Bydgoszcz
Bydgoszcz, , Poland
Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
Elblag, , Poland
Malopolskie Badania Kliniczne
Krakow, , Poland
Grazyna Pulka Specjalistyczny Osrodek All-med
Krak, , Poland
Pratia MCM Krakow
Krak, , Poland
AMED Centrum Medyczne
Lodz, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej Lecznica Mak-Med Spolka Cywilna
Nadarzyn, , Poland
Centrum Badan Klinicznych S.C.
Poznan, , Poland
Ai Centrum Medyczne
Poznan, , Poland
Nasz Lekarz Przychodnie Medyczne
Torun, , Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, , Poland
Ars Rheumatica - Reumatika Centrum Reumatologii
Warsaw, , Poland
Centrum Medyczne AMED Warszawa Targowek
Warsaw, , Poland
WroMedica
Wroclaw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, , Russia
Scientific Research Medical Complex
Kazan', , Russia
Medical Center Revma-Med
Kemerovo, , Russia
Clinic on Maroseyka
Moscow, , Russia
Medical Center Health Family
Novosibirsk, , Russia
State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova
Petrozavodsk, , Russia
Clinical Rheumatological Hospital Number 25
Saint Petersburg, , Russia
Polyclinic of Private Security Personnel
Saint Petersburg, , Russia
LLC Medical Consultation and Research Center-Practice
Yarolavl, , Russia
Clinical Hospital named after NA Semashko
Yaroslavl, , Russia
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Corporacio Sanitaria Parc Tauli
Sabadell, , Spain
Hospital Nuestra Senora de la Esperanza
Santiago de Compostela, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, , United Kingdom
The Princess Alexandra Hospital NHS Trust
Harlow, , United Kingdom
Countries
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References
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Deodhar A, Nowak M, Ye JY, Lehman T, Banerjee S, Mease PJ. Efficacy and Safety of Deucravacitinib, a Selective, Allosteric TYK2 Inhibitor, by Baseline DMARD Use in a Phase 2 Psoriatic Arthritis Study: A Post Hoc Analysis. Rheumatol Ther. 2025 Oct;12(5):873-887. doi: 10.1007/s40744-025-00776-4. Epub 2025 Jul 5.
FitzGerald O, Gladman DD, Mease PJ, Ritchlin C, Smolen JS, Gao L, Hu Y, Nowak M, Banerjee S, Catlett I. Phase 2 Trial of Deucravacitinib in Psoriatic Arthritis: Biomarkers Associated With Disease Activity, Pharmacodynamics, and Clinical Responses. Arthritis Rheumatol. 2024 Sep;76(9):1397-1407. doi: 10.1002/art.42921. Epub 2024 Jul 1.
Strand V, Gossec L, Coates LC, Ogdie A, Choi J, Becker B, Zhuo J, Lehman T, Nowak M, Elegbe A, Mease PJ, Deodhar A. Improvements in Patient-Reported Outcomes After Treatment With Deucravacitinib in Patients With Psoriatic Arthritis: Results From a Randomized Phase 2 Trial. Arthritis Care Res (Hoboken). 2024 Aug;76(8):1139-1148. doi: 10.1002/acr.25333. Epub 2024 May 7.
Mease PJ, Deodhar AA, van der Heijde D, Behrens F, Kivitz AJ, Neal J, Kim J, Singhal S, Nowak M, Banerjee S. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. Ann Rheum Dis. 2022 Jun;81(6):815-822. doi: 10.1136/annrheumdis-2021-221664. Epub 2022 Mar 3.
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
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2018-004293-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM011-084
Identifier Type: -
Identifier Source: org_study_id
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