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/study/NCT04908189




Registration number
NCT04908189
Ethics application status
Date submitted
28/05/2021
Date registered
1/06/2021
Date last updated
1/03/2024

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 or Had Previously Received TNFa Inhibitor Treatment
Scientific 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 TNFa Inhibitor Treatment
Secondary ID [1] 0 0
2020-005099-36
Secondary ID [2] 0 0
IM011-055
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
Treatment: Drugs - Apremilast

Experimental: Deucravacitinib -

Placebo comparator: Placebo -

Other: Apremilast -


Treatment: Drugs: Deucravacitinib
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days

Treatment: Drugs: Apremilast
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% (ACR20)
Timepoint [1] 0 0
At week 16
Secondary outcome [1] 0 0
Change from baseline Disease Activity Score 28 with C-Reactive Protein (DAS28-CRP)
Timepoint [1] 0 0
At week 16
Secondary outcome [2] 0 0
Change from baseline Health Assessment Questionnaire - Disability Index (HAQ-DI)
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 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 among the participants with dactylitis at baseline
Timepoint [8] 0 0
At week 16
Secondary outcome [9] 0 0
Proportion of participants meeting ACR 20 response
Timepoint [9] 0 0
Up to 16 weeks
Secondary outcome [10] 0 0
Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response
Timepoint [10] 0 0
Up to 16 weeks
Secondary outcome [11] 0 0
Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response
Timepoint [11] 0 0
Up to 16 weeks
Secondary outcome [12] 0 0
Change from baseline in HAQ-DI score
Timepoint [12] 0 0
Up to 16 weeks
Secondary outcome [13] 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 [13] 0 0
Up to 16 weeks
Secondary outcome [14] 0 0
Proportion of participants meeting PASI 75 response
Timepoint [14] 0 0
Up to 16 weeks
Secondary outcome [15] 0 0
Proportion of participants meeting PASI 90 response
Timepoint [15] 0 0
Up to 16 weeks
Secondary outcome [16] 0 0
Proportion of participants meeting PASI 100 response
Timepoint [16] 0 0
Up to 16 weeks
Secondary outcome [17] 0 0
Change from baseline in the SF-36 PCS score
Timepoint [17] 0 0
Up to 16 weeks
Secondary outcome [18] 0 0
Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI
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 Spondyloarthritis Research Consortium of Canada (SPARCC)
Timepoint [19] 0 0
Up to 16 weeks
Secondary outcome [20] 0 0
Proportion of participants meeting achievement of MDA
Timepoint [20] 0 0
Up to 16 weeks
Secondary outcome [21] 0 0
Change from baseline in SF-36 Mental Component Summary (MCS) score
Timepoint [21] 0 0
Up to 16 weeks
Secondary outcome [22] 0 0
Change from baseline in FACIT-Fatigue score
Timepoint [22] 0 0
Up to 16 weeks
Secondary outcome [23] 0 0
Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline
Timepoint [23] 0 0
Up to 16 weeks
Secondary outcome [24] 0 0
Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score
Timepoint [24] 0 0
Up to 16 weeks
Secondary outcome [25] 0 0
Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score
Timepoint [25] 0 0
Up to 16 weeks
Secondary outcome [26] 0 0
Proportion of participants with achievement of DAPSA low disease activity response
Timepoint [26] 0 0
Up to 16 weeks
Secondary outcome [27] 0 0
Proportion of participants with achievement of DAPSA disease remission
Timepoint [27] 0 0
Up to 16 weeks
Secondary outcome [28] 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 [28] 0 0
Up to 16 weeks
Secondary outcome [29] 0 0
Change from baseline in DAS28-CRP score
Timepoint [29] 0 0
Up to 16 weeks
Secondary outcome [30] 0 0
Proportion of participants with achievement of a DAS28-CRP low disease activity response
Timepoint [30] 0 0
Up to 16 weeks
Secondary outcome [31] 0 0
Proportion of participants with achievement of a DAS28-CRP disease remission
Timepoint [31] 0 0
Up to 16 weeks
Secondary outcome [32] 0 0
Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
Timepoint [32] 0 0
Up to 16 weeks
Secondary outcome [33] 0 0
Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score
Timepoint [33] 0 0
Up to 16 weeks
Secondary outcome [34] 0 0
Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC)
Timepoint [34] 0 0
Up to 16 weeks
Secondary outcome [35] 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 [35] 0 0
Up to 16 weeks
Secondary outcome [36] 0 0
Change from baseline in domain scales scores of SF-36
Timepoint [36] 0 0
Up to 16 weeks
Secondary outcome [37] 0 0
Change from baseline in PCS score of SF-36
Timepoint [37] 0 0
Up to 16 weeks
Secondary outcome [38] 0 0
Change from baseline in MCS score of SF- 36
Timepoint [38] 0 0
Up to 16 weeks
Secondary outcome [39] 0 0
Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire
Timepoint [39] 0 0
Up to 16 weeks
Secondary outcome [40] 0 0
Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D-5L) utility scores
Timepoint [40] 0 0
Up to 16 weeks
Secondary outcome [41] 0 0
Change from baseline in the 5-level EQ-5D utility score subcomponents
Timepoint [41] 0 0
Up to 16 weeks
Secondary outcome [42] 0 0
Change from baseline in Patient- Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form)
Timepoint [42] 0 0
Up to 16 weeks
Secondary outcome [43] 0 0
Incidence of Adverse Events (AEs)
Timepoint [43] 0 0
Up to week 156
Secondary outcome [44] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [44] 0 0
Up to week 156

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
15/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/11/2026
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0003 - Botany
Recruitment hospital [2] 0 0
BJC Health - Paramatta
Recruitment hospital [3] 0 0
Local Institution - 0004 - Maroochydore
Recruitment hospital [4] 0 0
Local Institution - 0099 - Woodville
Recruitment hospital [5] 0 0
Emeritus Research - Camberwell
Recruitment hospital [6] 0 0
Local Institution - 0017 - Geelong
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2150 - Paramatta
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3124 - Camberwell
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Distrito Federal
Country [23] 0 0
Argentina
State/province [23] 0 0
Tucuman
Country [24] 0 0
Argentina
State/province [24] 0 0
Cordoba
Country [25] 0 0
Belgium
State/province [25] 0 0
Brussels
Country [26] 0 0
Belgium
State/province [26] 0 0
Gent
Country [27] 0 0
Belgium
State/province [27] 0 0
Leuven
Country [28] 0 0
Belgium
State/province [28] 0 0
Liège
Country [29] 0 0
Canada
State/province [29] 0 0
British Columbia
Country [30] 0 0
Canada
State/province [30] 0 0
Ontario
Country [31] 0 0
Canada
State/province [31] 0 0
Quebec
Country [32] 0 0
China
State/province [32] 0 0
Anhui
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
China
State/province [34] 0 0
Guangdong
Country [35] 0 0
China
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Henan
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Liaoning
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China
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Neimeng
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China
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Shan3xi
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China
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Shanghai
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China
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Sichuan
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China
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Xinjiang
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China
State/province [45] 0 0
Yunnan
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China
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Zhejiang
Country [47] 0 0
Colombia
State/province [47] 0 0
Atlántico
Country [48] 0 0
Colombia
State/province [48] 0 0
Valle Del Cauca
Country [49] 0 0
Colombia
State/province [49] 0 0
Bogotá
Country [50] 0 0
Colombia
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Chía
Country [51] 0 0
Colombia
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Medellin
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Czechia
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Brno
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Czechia
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Ostrava
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Czechia
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Praha 2
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Czechia
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Uherske Hradiste
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Germany
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Nordrhein-Westfalen
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Germany
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Düsseldorf
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Germany
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Erlangen
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Germany
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Hamburg
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Germany
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Köln
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Germany
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Magdeburg
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Germany
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Minden
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Germany
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Tübingen
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Hungary
State/province [64] 0 0
Budapest
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Hungary
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Debrecen
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Hungary
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Gyula
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Hungary
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Kistarcsa
Country [68] 0 0
Hungary
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Szarvas
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Hungary
State/province [69] 0 0
Veszprem
Country [70] 0 0
Italy
State/province [70] 0 0
Firenze
Country [71] 0 0
Italy
State/province [71] 0 0
Potenza
Country [72] 0 0
Italy
State/province [72] 0 0
Roma
Country [73] 0 0
Japan
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Aichi
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Japan
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Hokkaido
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Japan
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MIE
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Fukuoka
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Mexico
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Distrito Federal
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Mexico
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Guanajuato
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Mexico
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Jalisco
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Mexico
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Yucatan
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Mexico
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Chihuahua
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Poland
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Kujawsko-pomorskie
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Poland
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Mazowieckie
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Poland
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Pomorskie
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Poland
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Elblag
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Poland
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Torun
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Poland
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Wroclaw
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Santander
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Spain
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València
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Taiwan
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Taichung City
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Taiwan
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Taichung
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Taiwan
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Taipei
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United Kingdom
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England
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United Kingdom
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Bradford
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United Kingdom
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Hull
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United Kingdom
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Liverpool
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United Kingdom
State/province [104] 0 0
London
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Manchester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04908189