Clinical trial NCT04908202: A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Biologic-Naive
BMS-986165
Deucravacitinib
Disease-modifying Anti-rheumatic Drugs
DMARDs
Joint Disease
Psoriatic Arthritis
PsA
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-06-01
Enrollment: 670
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 evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.


Eligibility criteria: Inclusion Criteria

* Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.
* Meets the Classification Criteria for Psoriatic Arthritis at Screening.
* Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening.
* Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1.
* Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening.
* ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading.
* Must have completed the week 52 treatment for the optional open-label long-term extension period.

Exclusion Criteria

* Nonplaque psoriasis at screening or day 1.
* Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis.
* History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
* Active fibromyalgia.
* Received an approved or investigational biologic therapy for the treatment of PsA or PsO.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response
timeFrame: At week 16
Secondary outcomes:
measure: Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score
timeFrame: At week 16
measure: Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score
timeFrame: At week 16
measure: Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response
timeFrame: At week 16
measure: Change from baseline in the Short Form-36 Physical Component Survey (SF-36 PCS) score
timeFrame: At week 16
measure: Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI)
timeFrame: At week 16
measure: Proportion of participants meeting achievement of Minimal Disease Activity (MDA)
timeFrame: At week 16
measure: Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
timeFrame: At week 16
measure: Proportion of participants meeting dactylitis resolution at week 16 among the participants with dactylitis at baseline
timeFrame: At week 16
measure: Change from baseline in PsA-modified Sharp-van der Heijde (SvdH) score
timeFrame: At week 16
measure: Proportion of participants meeting ACR 20 response
timeFrame: Up to 16 weeks
measure: Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response
timeFrame: Up to 16 weeks
measure: Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response
timeFrame: Up to 16 weeks
measure: Change from baseline in HAQ-DI score
timeFrame: Up to 16 weeks
measure: Proportion of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score ≥ 0.35 at baseline
timeFrame: Up to 16 weeks
measure: Proportion of participants with achievement of PASI 75 response
timeFrame: Up to 16 weeks
measure: Proportion of participants with achievement of PASI 90 response
timeFrame: Up to 16 weeks
measure: Proportion of participants with achievement of PASI 100 response
timeFrame: Up to 16 weeks
measure: Change from baseline in the SF-36 PCS score
timeFrame: Up to 16 weeks
measure: Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI
timeFrame: Up to 16 weeeks
measure: Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
timeFrame: Up to 16 weeks
measure: Proportion of participants meeting achievement of MDA
timeFrame: Up to 16 weeks
measure: Change from baseline in SF-36 Mental Component Summary (MCS) score
timeFrame: Up to 16 weeks
measure: Change from baseline in FACIT-Fatigue score
timeFrame: Up to 16 weeks
measure: Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline
timeFrame: Up to 16 weeks
measure: Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score
timeFrame: Up to 16 weeks
measure: Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score
timeFrame: Up to 16 weeks
measure: Proportion of participants with achievement of DAPSA low disease activity response
timeFrame: Up to 16 weeks
measure: Proportion of participants with achievement of DAPSA disease remission
timeFrame: Up to 16 weeks
measure: Proportion of participants meeting achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 in participants with a baseline PGA-F score of ≥ 3
timeFrame: Up to 16 weeks
measure: Change from baseline in DAS28-CRP score
timeFrame: Up to 16 weeks
measure: Proportion of participants with achievement of a DAS28-CRP low disease activity response
timeFrame: Up to 16 weeks
measure: Proportion of participants with achievement of a DAS28-CRP disease remission
timeFrame: Up to 16 weeks
measure: Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
timeFrame: Up to 16 weeks
measure: Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score
timeFrame: Up to 16 weeks
measure: Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC)
timeFrame: Up to 16 weeks
measure: Proportion of participants meeting achievement of improvement from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score among participants with spondylitis in addition to peripheral joint involvement as their presentation of PsA
timeFrame: Up to 16 weeks
measure: Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ 0
timeFrame: At week 16
measure: Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ 0.5
timeFrame: At week 16
measure: Proportion of participants meeting achievement of total PsA-modified SvdH score of ≤ smallest detectable change (SDC)
timeFrame: At week 16
measure: Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ 0
timeFrame: At week 16
measure: Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ 0.5
timeFrame: At week 16
measure: Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ SDC
timeFrame: At week 16
measure: Proportion of participants meeting achievement of PsA-modified SvdH joint space narrowing (JSN) score change of ≤ 0
timeFrame: At week 16
measure: Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of ≤ 0.5
timeFrame: At week 16
measure: Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of ≤ SDC
timeFrame: At week 16
measure: Change in PsA-modified SvdH erosion score from baseline
timeFrame: At week 16
measure: Change in PsA-modified SvdH JSN score
timeFrame: At week 16
measure: Change from baseline in domain scales scores of SF-36
timeFrame: Up to 16 weeks
measure: Change from baseline in PCS score of SF-36
timeFrame: Up to 16 weeks
measure: Change from baseline in MCS score of SF-36
timeFrame: Up to 16 weeks
measure: Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire
timeFrame: Up to 16 weeks
measure: Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D) utility scores
timeFrame: Up to 16 weeks
measure: Change from baseline in the 5-level EQ-5D-5L utility score subcomponents
timeFrame: Up to 16 weeks
measure: Change from baseline in Patient-Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form)
timeFrame: Up to 16 weeks
measure: Incidence of adverse events (AEs)
timeFrame: Up to 156 weeks
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 156 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Local Institution - 0197
state: Arizona
city: Jonesboro
country: United States
facility: Local Institution - 0188
state: Arkansas
city: Fontana
country: United States
facility: Local Institution - 0168
state: California
city: Fullerton
country: United States
facility: Local Institution - 0199
state: California
city: Sacramento
country: United States
facility: Local Institution - 0038
state: California
city: Thousand Oaks
country: United States
facility: Cohen Medical Centers
state: California
city: Denver
country: United States
facility: Local Institution - 0170
state: Colorado
city: Clearwater
country: United States
facility: Local Institution - 0195
state: Florida
city: Margate
country: United States
facility: Local Institution - 0272
state: Florida
city: Miami Lakes
country: United States
facility: Local Institution - 0082
state: Florida
city: Gainesville
country: United States
facility: Local Institution - 0171
state: Georgia
city: Boise
country: United States
facility: Local Institution - 0087
state: Idaho
city: Chicago
country: United States
facility: Local Institution - 0080
state: Illinois
city: Orland Park
country: United States
facility: Local Institution - 0177
state: Illinois
city: Schaumburg
country: United States
facility: Local Institution - 0178
state: Illinois
city: Lexington
country: United States
facility: Local Institution - 0083
state: Kentucky
city: Hagerstown
country: United States
facility: Local Institution - 0042
state: Maryland
city: Detroit
country: United States
facility: Local Institution - 0198
state: Michigan
city: Springfield
country: United States
facility: Local Institution - 0201
state: Missouri
city: Kalispell
country: United States
facility: Local Institution - 0268
state: Montana
city: Voorhees
country: United States
facility: Local Institution - 0186
state: New Jersey
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center-Dermatology
state: Ohio
city: Middleburg Heights
country: United States
facility: Local Institution - 0028
state: Ohio
city: Perrysburg
country: United States
facility: Local Institution - 0179
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 0182
state: Oklahoma
city: Corvallis
country: United States
facility: Local Institution - 0185
state: Oregon
city: Greenville
country: United States
facility: Local Institution - 0175
state: South Carolina
city: Jackson
country: United States
facility: Local Institution - 0036
state: Tennessee
city: Allen
country: United States
facility: Local Institution - 0172
state: Texas
city: Amarillo
country: United States
facility: Local Institution - 0189
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0032
state: Texas
city: Bothell
country: United States
facility: Local Institution - 0273
state: Washington
city: Beckley
country: United States
facility: Local Institution - 0181
state: West Virginia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0213
state: Buenos Aires
city: La Plata
country: Argentina
facility: Local Institution - 0054
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Local Institution - 0215
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Local Institution - 0046
state: Cordoba
city: Rosario
country: Argentina
facility: Local Institution - 0196
state: Santa Fe
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution - 0047
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution - 0194
city: Buenos Aires
country: Argentina
facility: Local Institution - 0169
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0192
city: Mendoza
country: Argentina
facility: Local Institution - 0193
city: Phillip
country: Australia
facility: Local Institution - 0220
state: Australian Capital Territory
city: Botany
country: Australia
facility: Local Institution - 0137
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution - 0133
state: New South Wales
city: Woolloongabba
country: Australia
facility: Local Institution - 0132
state: Queensland
city: Hobart
country: Australia
facility: Local Institution - 0211
state: Tasmania
city: Camberwell
country: Australia
facility: Local Institution - 0136
state: Victoria
city: Salvador
country: Brazil
facility: Local Institution - 0001
state: Bahia
city: Vitória
country: Brazil
facility: Local Institution - 0109
state: Espirito Santo
city: Juiz de Fora
country: Brazil
facility: Local Institution - 0002
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution - 0219
state: Paraná
city: Curitiba
country: Brazil
facility: Local Institution - 0214
state: Paraná
city: Porto Alegre
country: Brazil
facility: Local Institution - 0005
state: RIO Grande DO SUL
city: Santo Andre
country: Brazil
facility: Local Institution - 0108
state: São Paulo
city: Пловдив
country: Bulgaria
facility: Local Institution - 0255
state: Plovdiv
city: Sofia
country: Bulgaria
facility: Local Institution - 0248
state: Sofia (stolitsa)
city: Burgas
country: Bulgaria
facility: Local Institution - 0253
city: Plovdiv
country: Bulgaria
facility: Local Institution - 0249
city: Plovdiv
country: Bulgaria
facility: Local Institution - 0267
city: Plovdiv
country: Bulgaria
facility: Local Institution - 0246
city: Plovdiv
country: Bulgaria
facility: Local Institution - 0247
city: Sofia
country: Bulgaria
facility: Local Institution - 0245
city: Sofia
country: Bulgaria
facility: Local Institution - 0259
city: Varna
country: Bulgaria
facility: Local Institution - 0250
city: Santiago
country: Chile
facility: Local Institution - 0073
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0111
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution - 0226
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0099
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0222
state: Región Metropolitana De Santiago
city: Viña del Mar
country: Chile
facility: Local Institution - 0261
state: Valparaiso
city: Hefei
country: China
facility: Local Institution - 0149
state: Anhui
city: Beijing
country: China
facility: Local Institution - 0159
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0190
state: Chongqing
city: Guangzhou
country: China
facility: Local Institution - 0147
state: Guangdong
city: Shenzhen
country: China
facility: Local Institution - 0143
state: Guangdong
city: DaLian
country: China
facility: Local Institution - 0150
state: Liaoning
city: Shanghai
country: China
facility: Local Institution - 0146
state: Shanghai
city: Yiwu
country: China
facility: Local Institution - 0145
state: Zhejiang
city: Bucaramanga
country: Colombia
facility: Local Institution - 0071
state: Santander
city: Barranquilla
country: Colombia
facility: Local Institution - 0072
city: Bogota
country: Colombia
facility: Local Institution - 0063
city: Bogotá
country: Colombia
facility: Local Institution - 0069
city: Cali
country: Colombia
facility: Local Institution - 0070
city: Medellin
country: Colombia
facility: Local Institution - 0094
city: Medellin
country: Colombia
facility: Local Institution - 0064
city: Zipaquira
country: Colombia
facility: Local Institution - 0065
city: Praha
country: Czechia
facility: Local Institution - 0225
state: Praha 5
city: Uherske Hradiste
country: Czechia
facility: Local Institution - 0269
state: Zlínský Kraj
city: Zlín
country: Czechia
facility: Local Institution - 0202
state: Zlínský Kraj
city: Ostrava
country: Czechia
facility: Local Institution - 0018
city: Pardubice
country: Czechia
facility: Local Institution - 0208
city: Praha 2
country: Czechia
facility: Local Institution - 0097
city: Praha
country: Czechia
facility: Local Institution - 0017
city: Kuopio
country: Finland
facility: Local Institution - 0089
state: Pohjois-Savo
city: Helsinki
country: Finland
facility: Local Institution - 0013
city: Turku
country: Finland
facility: Local Institution - 0119
city: Chambray Les Tours
country: France
facility: Local Institution - 0077
city: Montpellier
country: France
facility: Local Institution - 0075
city: Paris
country: France
facility: Local Institution - 0074
city: Gyula
country: Hungary
facility: Local Institution - 0270
state: Békés
city: Székesfehérvár
country: Hungary
facility: Local Institution - 0049
state: Fejér
city: Budapest
country: Hungary
facility: Local Institution - 0023
city: Budapest
country: Hungary
facility: Local Institution - 0142
city: Budapest
country: Hungary
facility: Local Institution - 0026
city: Budapest
country: Hungary
facility: Local Institution - 0025
city: Budapest
country: Hungary
facility: Local Institution - 0203
city: Zalaegerszeg
country: Hungary
facility: Local Institution - 0068
city: Manorhamilton
country: Ireland
facility: Local Institution - 0104
state: Leitrim
city: Dublin
country: Ireland
facility: Local Institution - 0101
city: Dublin
country: Ireland
facility: Local Institution - 0102
city: Galway
country: Ireland
facility: Local Institution - 0103
city: Genova
country: Italy
facility: Local Institution - 0066
city: Pavia
country: Italy
facility: Local Institution - 0062
city: Udine
country: Italy
facility: Local Institution - 0096
city: Verona
country: Italy
facility: Local Institution - 0058
city: Saltillo
country: Mexico
facility: Local Institution - 0056
state: Coahuila
city: México
country: Mexico
facility: Local Institution - 0057
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution - 0254
state: Jalisco
city: San Luis Potosí
country: Mexico
facility: Local Institution - 0128
state: SAN LUIS Potosi
city: Merida
country: Mexico
facility: Local Institution - 0212
state: Yucatán
city: Mérida
country: Mexico
facility: Local Institution - 0061
state: Yucatán
city: Chihuahua
country: Mexico
facility: Local Institution - 0060
city: Mexico City
country: Mexico
facility: Local Institution - 0209
city: Veracruz
country: Mexico
facility: Local Institution - 0095
city: Wroclaw
country: Poland
facility: Local Institution - 0244
state: Dolnośląskie
city: Lublin
country: Poland
facility: Local Institution - 0232
state: Lubelskie
city: Swidnik
country: Poland
facility: Local Institution - 0230
state: Lubelskie
city: Nadarzyn
country: Poland
facility: Local Institution - 0233
state: Mazowieckie
city: Warszawa
country: Poland
facility: Local Institution - 0235
state: Mazowieckie
city: Warszawa
country: Poland
facility: Local Institution - 0243
state: Mazowieckie
city: Wołomin
country: Poland
facility: Local Institution - 0236
state: Mazowieckie
city: Kraków
country: Poland
facility: Local Institution - 0229
state: Małopolskie
city: Nowy Targ
country: Poland
facility: Local Institution - 0206
state: Małopolskie
city: Gdansk
country: Poland
facility: Local Institution - 0257
state: Pomorskie
city: Gdynia
country: Poland
facility: Local Institution - 0234
state: Pomorskie
city: Dąbrówka
country: Poland
facility: Local Institution - 0231
state: Wielkopolskie
city: Bialystok
country: Poland
facility: Local Institution - 0114
city: Krakow
country: Poland
facility: Local Institution - 0140
city: Kraków
country: Poland
facility: Local Institution - 0126
city: Kraków
country: Poland
facility: Local Institution - 0127
city: Olsztyn
country: Poland
facility: Local Institution - 0162
city: Poznan
country: Poland
facility: Local Institution - 0113
city: Poznan
country: Poland
facility: Local Institution - 0239
city: Poznan
country: Poland
facility: Local Institution - 0112
city: Warszawa
country: Poland
facility: Local Institution - 0204
city: Warszawa
country: Poland
facility: Local Institution - 0205
city: Warszawa
country: Poland
facility: Local Institution - 0125
city: Wroclaw
country: Poland
facility: Local Institution - 0210
city: Lodz
country: Poland
facility: Local Institution - 0238
state: Łódzkie
city: Czestochowa
country: Poland
facility: Local Institution - 0241
state: Śląskie
city: Katowice
country: Poland
facility: Local Institution - 0252
state: Śląskie
city: Bucharest
country: Romania
facility: Local Institution - 0090
state: București
city: Bucuresti
country: Romania
facility: Local Institution - 0266
state: București
city: Râmnicu Vâlcea
country: Romania
facility: Local Institution - 0010
state: Vâlcea
city: Brasov
country: Romania
facility: Local Institution - 0012
city: Bucharest
country: Romania
facility: Local Institution - 0167
city: Bucharest
country: Romania
facility: Local Institution - 0263
city: Bucharest
country: Romania
facility: Local Institution - 0184
city: Bucuresti
country: Romania
facility: Local Institution - 0260
city: Cluj Napoca
country: Romania
facility: Local Institution - 0011
city: Craiova
country: Romania
facility: Local Institution - 0258
city: Iasi
country: Romania
facility: Local Institution - 0264
city: Iași
country: Romania
facility: Local Institution - 0262
city: Iași
country: Romania
facility: Local Institution - 0265
city: Timisoara
country: Romania
facility: Local Institution - 0091
city: Kemerovo
country: Russian Federation
facility: Local Institution
city: Korolev
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: A Coruña
country: Spain
facility: Local Institution - 0021
city: Cordoba
country: Spain
facility: Local Institution - 0022
city: Madrid
country: Spain
facility: Local Institution - 0019
city: Sabadell
country: Spain
facility: Local Institution - 0020
city: Kaohsiung City
country: Taiwan
facility: Local Institution - 0123
city: Tainan City
country: Taiwan
facility: Local Institution - 0121
city: Tainan
country: Taiwan
facility: Local Institution - 0122
city: Taipei City
country: Taiwan
facility: Local Institution - 0120
city: Taoyuan
country: Taiwan
facility: Local Institution - 0124
city: Southampton
country: United Kingdom
facility: Local Institution - 0106
state: Hampshire
city: Harlow
country: United Kingdom
facility: Local Institution - 0116
city: Stoke-on-Trent
country: United Kingdom
facility: Local Institution - 0107
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: