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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
13/04/2025

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
Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16
Timepoint [1] 0 0
Baseline, Week 16
Secondary outcome [2] 0 0
Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16
Timepoint [2] 0 0
Baseline, Week 16
Secondary outcome [3] 0 0
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16
Timepoint [4] 0 0
Baseline, Week 16
Secondary outcome [5] 0 0
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16
Timepoint [7] 0 0
Baseline, Week 16
Secondary outcome [8] 0 0
Number of Participants Meeting Dactylitis Resolution at Week 16
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16
Timepoint [10] 0 0
Week 16
Secondary outcome [11] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Timepoint [11] 0 0
Baseline, Weeks 2, 4, 8, 12, 16
Secondary outcome [12] 0 0
Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16
Timepoint [12] 0 0
Week 16
Secondary outcome [13] 0 0
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)
Timepoint [13] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [14] 0 0
Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)
Timepoint [14] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [15] 0 0
Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)
Timepoint [15] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [16] 0 0
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score
Timepoint [16] 0 0
Baseline, Weeks 4, 12, 16
Secondary outcome [17] 0 0
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)
Timepoint [17] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [18] 0 0
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Timepoint [18] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [19] 0 0
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)
Timepoint [19] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [20] 0 0
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score
Timepoint [20] 0 0
Baseline, Weeks 4, 12, 16
Secondary outcome [21] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
Timepoint [21] 0 0
Baseline, Weeks 2, 4, 8, 12, 16
Secondary outcome [22] 0 0
Number of Participants Meeting Dactylitis Resolution
Timepoint [22] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [23] 0 0
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
Timepoint [23] 0 0
Baseline, Weeks 2, 4, 8, 12, 16
Secondary outcome [24] 0 0
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
Timepoint [24] 0 0
Baseline, Weeks 2, 4, 8, 12, 16
Secondary outcome [25] 0 0
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
Timepoint [25] 0 0
Weeks 2, 4, 8, 12, 16
Secondary outcome [26] 0 0
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
Timepoint [26] 0 0
Weeks 2, 4, 8, 12, 16
Secondary outcome [27] 0 0
Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1
Timepoint [27] 0 0
Weeks 4, 8, 12, 16
Secondary outcome [28] 0 0
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
Timepoint [28] 0 0
Baseline, Weeks 2, 4, 8, 12, 16
Secondary outcome [29] 0 0
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
Timepoint [29] 0 0
Weeks 2, 4, 8, 12, 16
Secondary outcome [30] 0 0
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
Timepoint [30] 0 0
Weeks 2, 4, 8, 12, 16
Secondary outcome [31] 0 0
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
Timepoint [31] 0 0
Baseline, Weeks 4, 12, 16
Secondary outcome [32] 0 0
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)
Timepoint [32] 0 0
Baseline, Weeks 4, 8, 12, 16
Secondary outcome [33] 0 0
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
Timepoint [33] 0 0
Weeks 2, 4, 8, 12, 16
Secondary outcome [34] 0 0
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
Timepoint [34] 0 0
Weeks 2, 4, 8, 12, 16
Secondary outcome [35] 0 0
Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16
Timepoint [35] 0 0
Baseline, Week 16
Secondary outcome [36] 0 0
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
Timepoint [36] 0 0
Baseline, Weeks 4, 16
Secondary outcome [37] 0 0
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)
Timepoint [37] 0 0
Baseline, Weeks 4, 12, 16

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
Accrual to date
Final
729
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - 0003 - Botany
Recruitment hospital [2] 0 0
Local Institution - 0018 - Paramatta
Recruitment hospital [3] 0 0
Local Institution - 0004 - Maroochydore
Recruitment hospital [4] 0 0
Local Institution - 0099 - Woodville
Recruitment hospital [5] 0 0
Local Institution - 0002 - 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
State/province [35] 0 0
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
Country [40] 0 0
China
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Neimeng
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China
State/province [41] 0 0
Shan3xi
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China
State/province [42] 0 0
Shanghai
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China
State/province [43] 0 0
Sichuan
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China
State/province [44] 0 0
Xinjiang
Country [45] 0 0
China
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Yunnan
Country [46] 0 0
China
State/province [46] 0 0
Zhejiang
Country [47] 0 0
Colombia
State/province [47] 0 0
Atlántico
Country [48] 0 0
Colombia
State/province [48] 0 0
Bogotá
Country [49] 0 0
Colombia
State/province [49] 0 0
Cali
Country [50] 0 0
Colombia
State/province [50] 0 0
Chía
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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
Country [57] 0 0
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
Country [61] 0 0
Germany
State/province [61] 0 0
Magdeburg
Country [62] 0 0
Germany
State/province [62] 0 0
Minden
Country [63] 0 0
Germany
State/province [63] 0 0
Tübingen
Country [64] 0 0
Hungary
State/province [64] 0 0
Veszprém City
Country [65] 0 0
Hungary
State/province [65] 0 0
Budapest
Country [66] 0 0
Hungary
State/province [66] 0 0
Debrecen
Country [67] 0 0
Hungary
State/province [67] 0 0
Gyula
Country [68] 0 0
Hungary
State/province [68] 0 0
Hódmezovásárhely
Country [69] 0 0
Hungary
State/province [69] 0 0
Kistarcsa
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
State/province [73] 0 0
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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Pomorskie
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Poland
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Elblag
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Poland
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Torun
Country [89] 0 0
Poland
State/province [89] 0 0
Wroclaw
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Sankt-Peterburg
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Moscow
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Russian Federation
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Saint Petersburg
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Spain
State/province [93] 0 0
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
Country [104] 0 0
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04908189