Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04908202




Registration number
NCT04908202
Ethics application status
Date submitted
28/05/2021
Date registered
1/06/2021
Date last updated
31/05/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2020-005097-10
Secondary ID [2] 0 0
IM011-054
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Deucravacitinib
Other interventions - Placebo

Experimental: Deucravacitinib -

Placebo Comparator: Placebo -


Treatment: Drugs: Deucravacitinib
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response
Timepoint [1] 0 0
At week 16
Secondary outcome [1] 0 0
Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score
Timepoint [1] 0 0
At week 16
Secondary outcome [2] 0 0
Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score
Timepoint [2] 0 0
At week 16
Secondary outcome [3] 0 0
Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response
Timepoint [3] 0 0
At week 16
Secondary outcome [4] 0 0
Change from baseline in the Short Form-36 Physical Component Survey (SF-36 PCS) score
Timepoint [4] 0 0
At week 16
Secondary outcome [5] 0 0
Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI)
Timepoint [5] 0 0
At week 16
Secondary outcome [6] 0 0
Proportion of participants meeting achievement of Minimal Disease Activity (MDA)
Timepoint [6] 0 0
At week 16
Secondary outcome [7] 0 0
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
Timepoint [7] 0 0
At week 16
Secondary outcome [8] 0 0
Proportion of participants meeting dactylitis resolution at week 16 among the participants with dactylitis at baseline
Timepoint [8] 0 0
At week 16
Secondary outcome [9] 0 0
Change from baseline in PsA-modified Sharp-van der Heijde (SvdH) score
Timepoint [9] 0 0
At week 16
Secondary outcome [10] 0 0
Proportion of participants meeting ACR 20 response
Timepoint [10] 0 0
Up to 16 weeks
Secondary outcome [11] 0 0
Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response
Timepoint [11] 0 0
Up to 16 weeks
Secondary outcome [12] 0 0
Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response
Timepoint [12] 0 0
Up to 16 weeks
Secondary outcome [13] 0 0
Change from baseline in HAQ-DI score
Timepoint [13] 0 0
Up to 16 weeks
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Up to 16 weeks
Secondary outcome [15] 0 0
Proportion of participants with achievement of PASI 75 response
Timepoint [15] 0 0
Up to 16 weeks
Secondary outcome [16] 0 0
Proportion of participants with achievement of PASI 90 response
Timepoint [16] 0 0
Up to 16 weeks
Secondary outcome [17] 0 0
Proportion of participants with achievement of PASI 100 response
Timepoint [17] 0 0
Up to 16 weeks
Secondary outcome [18] 0 0
Change from baseline in the SF-36 PCS score
Timepoint [18] 0 0
Up to 16 weeks
Secondary outcome [19] 0 0
Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI
Timepoint [19] 0 0
Up to 16 weeeks
Secondary outcome [20] 0 0
Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Timepoint [20] 0 0
Up to 16 weeks
Secondary outcome [21] 0 0
Proportion of participants meeting achievement of MDA
Timepoint [21] 0 0
Up to 16 weeks
Secondary outcome [22] 0 0
Change from baseline in SF-36 Mental Component Summary (MCS) score
Timepoint [22] 0 0
Up to 16 weeks
Secondary outcome [23] 0 0
Change from baseline in FACIT-Fatigue score
Timepoint [23] 0 0
Up to 16 weeks
Secondary outcome [24] 0 0
Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline
Timepoint [24] 0 0
Up to 16 weeks
Secondary outcome [25] 0 0
Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score
Timepoint [25] 0 0
Up to 16 weeks
Secondary outcome [26] 0 0
Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score
Timepoint [26] 0 0
Up to 16 weeks
Secondary outcome [27] 0 0
Proportion of participants with achievement of DAPSA low disease activity response
Timepoint [27] 0 0
Up to 16 weeks
Secondary outcome [28] 0 0
Proportion of participants with achievement of DAPSA disease remission
Timepoint [28] 0 0
Up to 16 weeks
Secondary outcome [29] 0 0
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
Timepoint [29] 0 0
Up to 16 weeks
Secondary outcome [30] 0 0
Change from baseline in DAS28-CRP score
Timepoint [30] 0 0
Up to 16 weeks
Secondary outcome [31] 0 0
Proportion of participants with achievement of a DAS28-CRP low disease activity response
Timepoint [31] 0 0
Up to 16 weeks
Secondary outcome [32] 0 0
Proportion of participants with achievement of a DAS28-CRP disease remission
Timepoint [32] 0 0
Up to 16 weeks
Secondary outcome [33] 0 0
Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
Timepoint [33] 0 0
Up to 16 weeks
Secondary outcome [34] 0 0
Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score
Timepoint [34] 0 0
Up to 16 weeks
Secondary outcome [35] 0 0
Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC)
Timepoint [35] 0 0
Up to 16 weeks
Secondary outcome [36] 0 0
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
Timepoint [36] 0 0
Up to 16 weeks
Secondary outcome [37] 0 0
Proportion of participants meeting achievement of total PsA-modified SvdH score of = 0
Timepoint [37] 0 0
At week 16
Secondary outcome [38] 0 0
Proportion of participants meeting achievement of total PsA-modified SvdH score of = 0.5
Timepoint [38] 0 0
At week 16
Secondary outcome [39] 0 0
Proportion of participants meeting achievement of total PsA-modified SvdH score of = smallest detectable change (SDC)
Timepoint [39] 0 0
At week 16
Secondary outcome [40] 0 0
Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of = 0
Timepoint [40] 0 0
At week 16
Secondary outcome [41] 0 0
Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of = 0.5
Timepoint [41] 0 0
At week 16
Secondary outcome [42] 0 0
Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of = SDC
Timepoint [42] 0 0
At week 16
Secondary outcome [43] 0 0
Proportion of participants meeting achievement of PsA-modified SvdH joint space narrowing (JSN) score change of = 0
Timepoint [43] 0 0
At week 16
Secondary outcome [44] 0 0
Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of = 0.5
Timepoint [44] 0 0
At week 16
Secondary outcome [45] 0 0
Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of = SDC
Timepoint [45] 0 0
At week 16
Secondary outcome [46] 0 0
Change in PsA-modified SvdH erosion score from baseline
Timepoint [46] 0 0
At week 16
Secondary outcome [47] 0 0
Change in PsA-modified SvdH JSN score
Timepoint [47] 0 0
At week 16
Secondary outcome [48] 0 0
Change from baseline in domain scales scores of SF-36
Timepoint [48] 0 0
Up to 16 weeks
Secondary outcome [49] 0 0
Change from baseline in PCS score of SF-36
Timepoint [49] 0 0
Up to 16 weeks
Secondary outcome [50] 0 0
Change from baseline in MCS score of SF-36
Timepoint [50] 0 0
Up to 16 weeks
Secondary outcome [51] 0 0
Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire
Timepoint [51] 0 0
Up to 16 weeks
Secondary outcome [52] 0 0
Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D) utility scores
Timepoint [52] 0 0
Up to 16 weeks
Secondary outcome [53] 0 0
Change from baseline in the 5-level EQ-5D-5L utility score subcomponents
Timepoint [53] 0 0
Up to 16 weeks
Secondary outcome [54] 0 0
Change from baseline in Patient-Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form)
Timepoint [54] 0 0
Up to 16 weeks
Secondary outcome [55] 0 0
Incidence of adverse events (AEs)
Timepoint [55] 0 0
Up to 156 weeks
Secondary outcome [56] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [56] 0 0
Up to 156 weeks

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/05/2027
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Local Institution - 0220 - Phillip
Recruitment hospital [2] 0 0
Local Institution - 0137 - Botany
Recruitment hospital [3] 0 0
Local Institution - 0133 - Westmead
Recruitment hospital [4] 0 0
Local Institution - 0132 - Woolloongabba
Recruitment hospital [5] 0 0
Local Institution - 0211 - Hobart
Recruitment hospital [6] 0 0
Local Institution - 0136 - Camberwell
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2019 - Botany
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3142 - Camberwell
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Maryland
Country [11] 0 0
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Michigan
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Missouri
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Montana
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United States of America
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New Jersey
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United States of America
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Ohio
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United States of America
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Oklahoma
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Oregon
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South Carolina
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Tennessee
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Texas
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Washington
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Cordoba
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Argentina
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Santa Fe
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Argentina
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Tucuman
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Argentina
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Mendoza
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Brazil
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Bahia
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Brazil
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Espirito Santo
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Brazil
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Minas Gerais
Country [32] 0 0
Brazil
State/province [32] 0 0
Paraná
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Brazil
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RIO Grande DO SUL
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Brazil
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São Paulo
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Bulgaria
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Burgas
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
State/province [38] 0 0
Varna
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Chile
State/province [39] 0 0
Metropolitana
Country [40] 0 0
Chile
State/province [40] 0 0
Región Metropolitana De Santiago
Country [41] 0 0
Chile
State/province [41] 0 0
Valparaíso
Country [42] 0 0
China
State/province [42] 0 0
Anhui
Country [43] 0 0
China
State/province [43] 0 0
Beijing
Country [44] 0 0
China
State/province [44] 0 0
Chongqing
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China
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Guangdong
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China
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Liaoning
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China
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Shanghai
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China
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Zhejiang
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Colombia
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Cundinamarca
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Colombia
State/province [50] 0 0
Santander
Country [51] 0 0
Colombia
State/province [51] 0 0
Barranquilla
Country [52] 0 0
Colombia
State/province [52] 0 0
Bogota
Country [53] 0 0
Colombia
State/province [53] 0 0
Cali
Country [54] 0 0
Colombia
State/province [54] 0 0
Medellin
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Colombia
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Zipaquira
Country [56] 0 0
Czechia
State/province [56] 0 0
Praha 5
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Czechia
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Zlínský Kraj
Country [58] 0 0
Czechia
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Ostrava
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Czechia
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Pardubice
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Czechia
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Praha 2
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Czechia
State/province [61] 0 0
Praha
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Finland
State/province [62] 0 0
Helsinki
Country [63] 0 0
Finland
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Kuopio
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Finland
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Turku
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France
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Chambray Les Tours
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France
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Montpellier
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France
State/province [67] 0 0
Paris
Country [68] 0 0
Hungary
State/province [68] 0 0
Békés
Country [69] 0 0
Hungary
State/province [69] 0 0
Fejér
Country [70] 0 0
Hungary
State/province [70] 0 0
Budapest
Country [71] 0 0
Hungary
State/province [71] 0 0
Zalaegerszeg
Country [72] 0 0
Ireland
State/province [72] 0 0
Leitrim
Country [73] 0 0
Ireland
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Dublin
Country [74] 0 0
Ireland
State/province [74] 0 0
Galway
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Italy
State/province [75] 0 0
Genova
Country [76] 0 0
Italy
State/province [76] 0 0
Pavia
Country [77] 0 0
Italy
State/province [77] 0 0
Udine
Country [78] 0 0
Italy
State/province [78] 0 0
Verona
Country [79] 0 0
Mexico
State/province [79] 0 0
Coahuila
Country [80] 0 0
Mexico
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Distrito Federal
Country [81] 0 0
Mexico
State/province [81] 0 0
Jalisco
Country [82] 0 0
Mexico
State/province [82] 0 0
SAN LUIS Potosi
Country [83] 0 0
Mexico
State/province [83] 0 0
Yucatán
Country [84] 0 0
Mexico
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Chihuahua
Country [85] 0 0
Mexico
State/province [85] 0 0
Veracruz
Country [86] 0 0
Poland
State/province [86] 0 0
Dolnoslaskie
Country [87] 0 0
Poland
State/province [87] 0 0
Lubelskie
Country [88] 0 0
Poland
State/province [88] 0 0
Mazowieckie
Country [89] 0 0
Poland
State/province [89] 0 0
Malopolskie
Country [90] 0 0
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Pomorskie
Country [91] 0 0
Poland
State/province [91] 0 0
Wielkopolskie
Country [92] 0 0
Poland
State/province [92] 0 0
Bialystok
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Poland
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Krakow
Country [94] 0 0
Poland
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Kraków
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Poland
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Olsztyn
Country [96] 0 0
Poland
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Poznan
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Poland
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Warszawa
Country [98] 0 0
Poland
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Wroclaw
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Poland
State/province [99] 0 0
Lódzkie
Country [100] 0 0
Poland
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Slaskie
Country [101] 0 0
Romania
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Bucure?ti
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Cluj Napoca
Country [106] 0 0
Romania
State/province [106] 0 0
Craiova
Country [107] 0 0
Romania
State/province [107] 0 0
Iasi
Country [108] 0 0
Romania
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Ia?i
Country [109] 0 0
Romania
State/province [109] 0 0
Râmnicu Vâlcea
Country [110] 0 0
Romania
State/province [110] 0 0
Timisoara
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Kemerovo
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Korolev
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Saint Petersburg
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Russian Federation
State/province [114] 0 0
Yaroslavl
Country [115] 0 0
Spain
State/province [115] 0 0
A Coruña
Country [116] 0 0
Spain
State/province [116] 0 0
Cordoba
Country [117] 0 0
Spain
State/province [117] 0 0
Madrid
Country [118] 0 0
Spain
State/province [118] 0 0
Sabadell
Country [119] 0 0
Taiwan
State/province [119] 0 0
Kaohsiung City
Country [120] 0 0
Taiwan
State/province [120] 0 0
Tainan City
Country [121] 0 0
Taiwan
State/province [121] 0 0
Tainan
Country [122] 0 0
Taiwan
State/province [122] 0 0
Taipei City
Country [123] 0 0
Taiwan
State/province [123] 0 0
Taoyuan
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Hampshire
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Harlow
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04908202
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04908202