Clinical trial NCT03881059: Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)
Official title: A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Multiple Doses of BMS-986165 in Subjects With Active Psoriatic Arthritis (PsA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Active Psoriatic Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-03-19
Enrollment: 203
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 main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A or Dose B once daily \[QD\]) at Week 16 in the treatment of participants with active PsA.

Detailed description: The study is intended to evaluate the safety and efficacy of BMS-986165 Dose A or B once daily (QD) compared with placebo in adults with active PsA. The primary endpoint is american college of rheumatology (ACR) 20 response at Week 16 (Part A).

Eligibility criteria: Inclusion Criteria:

* Diagnosed with PsA for at least 6 months before screening, and who meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
* 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 non-plaque psoriasis (that is (i.e.), guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at screening or Day 1
* 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

Primary outcomes:
measure: Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16
timeFrame: 16 weeks after first dose
Secondary outcomes:
measure: Adjusted Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: From baseline (day of the first dose) to 16 weeks after first dose
measure: Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 75 Response
timeFrame: 16 weeks after first dose
measure: Adjusted Change From Baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire
timeFrame: From baseline (day of the first dose) to 16 weeks after first dose
measure: Percentage of Participants Achieving the American College of Rheumatology (ACR) 50 Response at Week 16
timeFrame: 16 weeks after first dose
measure: Percentage of Participants Achieving the American College of Rheumatology (ACR) 70 Response at Week 16
timeFrame: 16 weeks after first dose
measure: Percentage of Participants Achieving Low Disease Activity According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)
timeFrame: 16 weeks after first dose
measure: Percentage of Participants Achieving Remission According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)
timeFrame: 16 weeks after first dose
measure: Adjusted Change From Baseline in the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) Score
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Adjusted Change From Baseline in Dactylitis Count
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Adjusted Change From Baseline in the Leeds Dactylitis Index (LDI) Basic Score
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Percentage of Participants Achieving Dactylitis Resolution
timeFrame: 16 weeks after first dose
measure: Adjusted Change From Baseline in Enthesitis by the Leeds Enthesitis Index (LEI)
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Adjusted Change From Baseline in Enthesitis by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Percentage of Participants Achieving Enthesitis Resolution by the Leeds Enthesitis Index (LEI)
timeFrame: 16 weeks after first dose
measure: Percentage of Participants Achieving Enthesitis Resolution by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
timeFrame: 16 weeks after first dose
measure: Percentage of Participants Achieving a Physicians Global Assessment-Fingernails (PGA-F) Score of 0 or 1
timeFrame: 16 weeks after first dose
measure: Percentage of Participants Achieving Minimal Disease Activity (MDA) Response
timeFrame: 16 weeks after first dose
measure: Adjusted Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS)
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Adjusted Change From Baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA)
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
timeFrame: 16 weeks after first dose
measure: Adjusted Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Adjusted Change From Baseline in the Mental Component Summary (MCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire
timeFrame: From baseline (day of the first dose) to 16 weeks after first dose
measure: Adjusted Change From Baseline in the Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
timeFrame: From baseline (day of the first dose) to 16 weeks after first dose
measure: Adjusted Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
timeFrame: From baseline (day of the first dose) to 16 weeks after first dose
measure: Adjusted Change From Baseline in the Work Limitation Questionnaire (WLQ) Score
timeFrame: From baseline (day of the first dose) to 16 weeks after first dose
measure: Percentage of Participants Achieving Health Assessment Questionnaire-Disability Index (HAQ-DI) 0.35 Response
timeFrame: 16 weeks after first dose
measure: Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 90 Response
timeFrame: 16 weeks after first dose
measure: Change From Baseline in Electrocardiogram (ECG) Results
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Change From Baseline in Electrocardiogram (ECG) Heart Rate
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Change From Baseline in Vital Signs - Diastolic Blood Pressure
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Change From Baseline in Vital Signs - Heart Rate
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Change From Baseline in Vital Signs - Respiratory Rate
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Change From Baseline in Vital Signs - Systolic Blood Pressure
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Change From Baseline in Vital Signs - Temperature
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
measure: Change From Baseline in Vital Signs - Weight
timeFrame: From baseline (day of first dose) to 16 weeks after first dose
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama
state: Alabama
city: Covina
country: United States
facility: Medvin Clinical Research - Covina Office
state: California
city: La Jolla
country: United States
facility: University of California at San Diego Medical Center
state: California
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants - Metrowest
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology & Immunology Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: BayCare Medical Group
state: Florida
city: Tampa
country: United States
facility: University of South Florida - Morsani College of Medicine
state: Florida
city: Wichita
country: United States
facility: Heartland Research Associates - East Wichita
state: Kansas
city: Lexington
country: United States
facility: Arthritis Center of Lexington
state: Kentucky
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Hattiesburg
country: United States
facility: Arthritis Associates
state: Mississippi
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Toms River
country: United States
facility: Atlantic Coast Rheumatology
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Center for Rheumatology
state: New Mexico
city: Albany
country: United States
facility: The Center for Rheumatology-Albany
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Charlotte
country: United States
facility: Joint Muscle Medical Care and Research Institute - Lilington Office
state: North Carolina
city: Charlotte
country: United States
facility: DJL Clinical Research
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research and Consulting
state: Ohio
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Summerville
country: United States
facility: Low Country Rheumatology
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Office of Ramesh C. Gupta, MD
state: Tennessee
city: Cypress
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research
state: Texas
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest Rheumatology
state: Washington
city: Hlu?
country: Czechia
facility: L.K.N. Arthrocentrum, s.r.o
city: Ostrava
country: Czechia
facility: CCR Ostrava
city: Ostrava
country: Czechia
facility: Revmatologie MUDr. Klara Sirova s.r.o.
city: Praha 10
country: Czechia
facility: Arthrocentrum
city: Praha 11 Chodov
country: Czechia
facility: Affidea Praha
city: Praha 3
country: Czechia
facility: CCR Prague
city: Praha 4
country: Czechia
facility: Nuselska Poliklinika
city: Praha
country: Czechia
facility: Revmatologicky Ustav
city: Zlin
country: Czechia
facility: PV-Medical Services, s.r.o.
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis PD Dr. med. Brandt Jurgens
city: Erlangen
country: Germany
facility: Universitatsklinikum Erlangen
city: Frankfurt am Main
country: Germany
facility: Universitatsklinikum Frankfurt
city: Hamburg
country: Germany
facility: HRF II - Hamburger Rheuma Forschungszentrum II - MVZ fur Rheumatologie und Autoimmunmedizin Hamburg
city: Magdeburg
country: Germany
facility: SMO.MD GmbH
city: Mannheim
country: Germany
facility: Universitatsmedizin Mannheim
city: Munchen
country: Germany
facility: Klinikum der Universitat Munchen
city: Budapest
country: Hungary
facility: Clinexpert Gyogycentrum
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Miskolc
country: Hungary
facility: CRU Hungary Egeszsegugyi es Szolgaltato Korlatolt Felelossegu Tarsasag
city: Szeged
country: Hungary
facility: Aranyklinika
city: Szekesfehervar
country: Hungary
facility: CMed Rehabilitacios es Diagnosztikai Kozpont
city: Szentes
country: Hungary
facility: Csongrad Megyei Dr. Bugyi Istvan Korhaz
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata di Verona
city: Bia?ystok
country: Poland
facility: Osteo-Medic
city: Bialystok
country: Poland
facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
city: Bialystok
country: Poland
facility: ClinicMed Daniluk Nowak Spolka Jawna
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych - Bydgoszcz
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy
city: Elblag
country: Poland
facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
city: Elblag
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
city: Krakow
country: Poland
facility: Malopolskie Badania Kliniczne
city: Krak
country: Poland
facility: Grazyna Pulka Specjalistyczny Osrodek All-med
city: Krak
country: Poland
facility: Pratia MCM Krakow
city: Lodz
country: Poland
facility: AMED Centrum Medyczne
city: Nadarzyn
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Lecznica Mak-Med Spolka Cywilna
city: Poznan
country: Poland
facility: Centrum Badan Klinicznych S.C.
city: Poznan
country: Poland
facility: Ai Centrum Medyczne
city: Torun
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne
city: Warszawa
country: Poland
facility: Rheuma Medicus Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Ars Rheumatica - Reumatika Centrum Reumatologii
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED Warszawa Targowek
city: Wroclaw
country: Poland
facility: WroMedica
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Hospital
city: Kazan
country: Russian Federation
facility: Scientific Research Medical Complex
city: Kemerovo
country: Russian Federation
facility: Medical Center Revma-Med
city: Moscow
country: Russian Federation
facility: Clinic on Maroseyka
city: Novosibirsk
country: Russian Federation
facility: Medical Center Health Family
city: Petrozavodsk
country: Russian Federation
facility: State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova
city: Saint Petersburg
country: Russian Federation
facility: Polyclinic of Private Security Personnel
city: Saint-Petersburg
country: Russian Federation
facility: Clinical Rheumatological Hospital Number 25
city: Yarolavl
country: Russian Federation
facility: LLC Medical Consultation and Research Center-Practice
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital named after NA Semashko
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Santiago de Compostela
country: Spain
facility: Hospital Nuestra Senora de la Esperanza
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
city: Harlow
country: United Kingdom
facility: The Princess Alexandra Hospital NHS Trust
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.