Clinical trial NCT04908189: 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 or Had Previously Received TNFα Inhibitor Treatment
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Psoriatic arthritis
PsA
Deucravacitinib
BMS-986165
Apremilast
Otezla
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-06-01
Enrollment: 729
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 safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy 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 (CASPAR) criteria 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
* 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: Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
timeFrame: Week 16
measure: Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16
timeFrame: Week 16
measure: Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16
timeFrame: Week 16
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants Meeting Dactylitis Resolution at Week 16
timeFrame: Week 16
measure: Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16
timeFrame: Week 16
measure: Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16
timeFrame: Week 16
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16
measure: Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16
timeFrame: Week 16
measure: Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)
timeFrame: Weeks 4, 8, 12, 16
measure: Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)
timeFrame: Weeks 4, 8, 12, 16
measure: Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)
timeFrame: Weeks 4, 8, 12, 16
measure: Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score
timeFrame: Baseline, Weeks 4, 12, 16
measure: Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)
timeFrame: Weeks 4, 8, 12, 16
measure: Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
timeFrame: Weeks 4, 8, 12, 16
measure: Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)
timeFrame: Weeks 4, 8, 12, 16
measure: Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score
timeFrame: Baseline, Weeks 4, 12, 16
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16
measure: Number of Participants Meeting Dactylitis Resolution
timeFrame: Weeks 4, 8, 12, 16
measure: Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16
measure: Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16
measure: Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
timeFrame: Weeks 2, 4, 8, 12, 16
measure: Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
timeFrame: Weeks 2, 4, 8, 12, 16
measure: Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1
timeFrame: Weeks 4, 8, 12, 16
measure: Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16
measure: Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
timeFrame: Weeks 2, 4, 8, 12, 16
measure: Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
timeFrame: Weeks 2, 4, 8, 12, 16
measure: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
timeFrame: Baseline, Weeks 4, 12, 16
measure: Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)
timeFrame: Baseline, Weeks 4, 8, 12, 16
measure: Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
timeFrame: Weeks 2, 4, 8, 12, 16
measure: Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
timeFrame: Weeks 2, 4, 8, 12, 16
measure: Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
timeFrame: Baseline, Weeks 4, 16
measure: Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)
timeFrame: Baseline, Weeks 4, 12, 16
Other outcomes:
Locations:
city: Mountain Brook
country: United States
facility: Local Institution - 0149
state: Alabama
city: Sacramento
country: United States
facility: Local Institution - 0212
state: California
city: Whittier
country: United States
facility: Local Institution - 0188
state: California
city: Skokie
country: United States
facility: Local Institution - 0192
state: Illinois
city: Hopkinsville
country: United States
facility: Local Institution - 0203
state: Kentucky
city: Baton Rouge
country: United States
facility: Local Institution - 0195
state: Louisiana
city: Cumberland
country: United States
facility: Local Institution - 0169
state: Maryland
city: Okemos
country: United States
facility: Local Institution - 0034
state: Michigan
city: Eagan
country: United States
facility: Local Institution - 0133
state: Minnesota
city: Hattiesburg
country: United States
facility: Local Institution - 0109
state: Mississippi
city: New York
country: United States
facility: Local Institution - 0108
state: New York
city: Rochester
country: United States
facility: Local Institution - 0186
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0196
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution - 0180
state: Ohio
city: Oklahoma City
country: United States
facility: Local Institution - 0189
state: Oklahoma
city: Portland
country: United States
facility: Local Institution - 0147
state: Oregon
city: Duncansville
country: United States
facility: Local Institution - 0016
state: Pennsylvania
city: Summerville
country: United States
facility: Local Institution - 0182
state: South Carolina
city: Lubbock
country: United States
facility: Local Institution - 0167
state: Texas
city: Mesquite
country: United States
facility: Local Institution - 0070
state: Texas
city: Plano
country: United States
facility: Local Institution - 0184
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0187
state: Washington
city: Franklin
country: United States
facility: Local Institution - 0190
state: Wisconsin
city: Milwaukee
country: United States
facility: Local Institution - 0175
state: Wisconsin
city: La Plata
country: Argentina
facility: Local Institution - 0048
state: Buenos Aires
city: San Isidro
country: Argentina
facility: Local Institution - 0038
state: Buenos Aires
city: Caba
country: Argentina
facility: Local Institution - 0039
state: Distrito Federal
city: San Miguel de Tucumán
country: Argentina
facility: Local Institution - 0171
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution - 0200
city: Botany
country: Australia
facility: Local Institution - 0003
state: New South Wales
city: Paramatta
country: Australia
facility: Local Institution - 0018
state: New South Wales
city: Maroochydore
country: Australia
facility: Local Institution - 0004
state: Queensland
city: Woodville
country: Australia
facility: Local Institution - 0099
state: South Australia
city: Camberwell
country: Australia
facility: Local Institution - 0002
state: Victoria
city: Geelong
country: Australia
facility: Local Institution - 0017
state: Victoria
city: Brussels
country: Belgium
facility: Local Institution - 0078
city: Gent
country: Belgium
facility: Local Institution - 0058
city: Liège
country: Belgium
facility: Local Institution - 0061
city: Vancouver
country: Canada
facility: Local Institution - 0111
state: British Columbia
city: Hamilton
country: Canada
facility: Local Institution - 0006
state: Ontario
city: Markham
country: Canada
facility: Local Institution - 0030
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0036
state: Ontario
city: Quebec
country: Canada
facility: Local Institution - 0001
city: Bengbu
country: China
facility: Local Institution - 0126
state: Anhui
city: Beijing
country: China
facility: Local Institution - 0152
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0146
state: Beijing
city: Guangzhou
country: China
facility: Local Institution - 0153
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0135
state: Guangdong
city: Shenzhen
country: China
facility: Local Institution - 0206
state: Guangdong
city: Zhengzhou
country: China
facility: Local Institution - 0127
state: Henan
city: Changsha
country: China
facility: Local Institution - 0170
state: Hunan
city: Changsha
country: China
facility: Local Institution - 0161
state: Hunan
city: Changzhou
country: China
facility: Local Institution - 0125
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution - 0138
state: Jiangsu
city: Nantong
country: China
facility: Local Institution - 0139
state: Jiangsu
city: Wuxi
country: China
facility: Local Institution - 0163
state: Jiangsu
city: Jiujiang
country: China
facility: Local Institution - 0148
state: Jiangxi
city: Nanchang
country: China
facility: Local Institution - 0131
state: Jiangxi
city: Nanchang
country: China
facility: Local Institution - 0156
state: Jiangxi
city: Pingxiang
country: China
facility: Local Institution - 0140
state: Jiangxi
city: Baotou
country: China
facility: Local Institution - 0158
state: Neimeng
city: Hohhot
country: China
facility: Local Institution - 0157
state: Neimeng
city: Xi'An
country: China
facility: Local Institution - 0154
state: Shan3xi
city: Shanghai
country: China
facility: Local Institution - 0207
state: Shanghai
city: Chengdu
country: China
facility: Local Institution - 0164
state: Sichuan
city: Urumqi
country: China
facility: Local Institution - 0117
state: Xinjiang
city: Kunming
country: China
facility: Local Institution - 0134
state: Yunnan
city: Wenzhou
country: China
facility: Local Institution - 0129
state: Zhejiang
city: Barranquilla
country: Colombia
facility: Local Institution - 0072
state: Atlántico
city: Bogotá
country: Colombia
facility: Local Institution - 0015
city: Cali
country: Colombia
facility: Local Institution - 0020
city: Chía
country: Colombia
facility: Local Institution - 0022
city: Medellin
country: Colombia
facility: Local Institution - 0019
city: Brno
country: Czechia
facility: Local Institution - 0010
city: Ostrava
country: Czechia
facility: Local Institution - 0009
city: Ostrava
country: Czechia
facility: Local Institution - 0035
city: Praha 2
country: Czechia
facility: Local Institution - 0011
city: Uherske Hradiste
country: Czechia
facility: Local Institution - 0023
city: Ratingen
country: Germany
facility: Local Institution - 0176
state: Nordrhein-Westfalen
city: Erlangen
country: Germany
facility: Local Institution - 0199
city: Hamburg
country: Germany
facility: Local Institution - 0046
city: Köln
country: Germany
facility: Local Institution - 0101
city: Magdeburg
country: Germany
facility: Local Institution - 0075
city: Minden
country: Germany
facility: Local Institution - 0201
city: Tübingen
country: Germany
facility: Local Institution - 0074
city: Veszprem
country: Hungary
facility: Local Institution - 0025
state: Veszprém City
city: Budapest
country: Hungary
facility: Local Institution - 0197
city: Debrecen
country: Hungary
facility: Local Institution - 0066
city: Gyula
country: Hungary
facility: Local Institution - 0028
city: Hódmezővásárhely
country: Hungary
facility: Local Institution - 0024
city: Kistarcsa
country: Hungary
facility: Local Institution - 0027
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi-Reumatologia
city: Potenza
country: Italy
facility: AOR San Carlo di Potenza-UOC Reumatologia
city: Roma
country: Italy
facility: Local Institution - 0097
city: Nagoya-shi
country: Japan
facility: Local Institution - 0106
state: Aichi
city: Nagoya
country: Japan
facility: Local Institution - 0202
state: Aichi
city: Sapporo
country: Japan
facility: Local Institution - 0151
state: Hokkaido
city: Tsu
country: Japan
facility: Local Institution - 0179
state: MIE
city: Kawachinagano
country: Japan
facility: Local Institution - 0123
state: Osaka
city: Bunkyō
country: Japan
facility: Local Institution - 0205
state: Tokyo
city: Chuo-ku
country: Japan
facility: Local Institution - 0121
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Local Institution - 0067
state: Tokyo
city: Meguro-ku
country: Japan
facility: Local Institution - 0178
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution - 0122
state: Tokyo
city: Mitaka
country: Japan
facility: Local Institution - 0174
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution - 0065
state: Tokyo
city: Fukuoka
country: Japan
facility: Local Institution - 0155
city: Osaka
country: Japan
facility: Local Institution - 0166
city: Osaka
country: Japan
facility: Local Institution - 0204
city: Mexico City
country: Mexico
facility: Local Institution - 0198
state: Distrito Federal
city: Leon
country: Mexico
facility: Local Institution - 0052
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Local Institution - 0051
state: Jalisco
city: Zapopan
country: Mexico
facility: Local Institution - 0057
state: Jalisco
city: Merida
country: Mexico
facility: Local Institution - 0056
state: Yucatan
city: Chihuahua
country: Mexico
facility: Local Institution - 0053
city: Bydgoszcz
country: Poland
facility: Local Institution - 0082
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Local Institution - 0177
state: Mazowieckie
city: Gdansk
country: Poland
facility: Local Institution - 0079
state: Pomorskie
city: Elblag
country: Poland
facility: Local Institution - 0080
city: Torun
country: Poland
facility: Local Institution - 0081
city: Wrocław
country: Poland
facility: Local Institution - 0112
city: Moscow
country: Russian Federation
facility: Local Institution
city: Novosibirsk
country: Russian Federation
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution - 0014
city: Madrid
country: Spain
facility: Local Institution - 0012
city: Santander
country: Spain
facility: Local Institution - 0045
city: València
country: Spain
facility: Local Institution - 0013
city: Taichung City
country: Taiwan
facility: Local Institution - 0090
city: Taichung
country: Taiwan
facility: Local Institution - 0088
city: Taichung
country: Taiwan
facility: Local Institution - 0089
city: Taipei
country: Taiwan
facility: Local Institution - 0091
city: Taipei
country: Taiwan
facility: Local Institution - 0087
city: London
country: United Kingdom
facility: Local Institution - 0185
state: England
city: Bradford
country: United Kingdom
facility: Local Institution - 0060
city: Hull
country: United Kingdom
facility: Local Institution - 0064
city: Liverpool
country: United Kingdom
facility: Local Institution - 0077
city: London
country: United Kingdom
facility: Local Institution - 0062
city: Manchester
country: United Kingdom
facility: Local Institution - 0105
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: