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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07116967




Registration number
NCT07116967
Ethics application status
Date submitted
4/08/2025
Date registered
12/08/2025
Date last updated
9/09/2025

Titles & IDs
Public title
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Scientific title
A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis
Secondary ID [1] 0 0
U1111-1291-5815
Secondary ID [2] 0 0
IM011-1130
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis 0 0
Condition category
Condition code

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

Experimental: Arm A -

Active comparator: Arm B -


Treatment: Drugs: Deucravacitinib
Specified dose on specified days

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

Outcomes
Primary outcome [1] 0 0
Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Number of participants with non-fatal MI
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Number of participants with non-fatal stroke
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Death due to cardiovascular events
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Number of participants with coronary revascularization
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death)
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Number of participants with pulmonary embolism (PE)
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Number of participants with deep vein thrombosis (DVT)
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Number of participants with composite venous thromboembolism (VTE)
Timepoint [8] 0 0
Up to 5 years
Secondary outcome [9] 0 0
Number of participants with arterial thromboembolic events (including retinal artery occlusion)
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
Number of participants with heart failure (HF) requiring hospitalization or urgent visit
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
Number of participants with Malignancy excluding non-melanoma skin cancer (NMSC)
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
Number of participants with NMSC
Timepoint [12] 0 0
Up to 5 years
Secondary outcome [13] 0 0
Number of participants with opportunistic infections
Timepoint [13] 0 0
Up to 5 years
Secondary outcome [14] 0 0
Number of participants with Serious AEs (SAEs)
Timepoint [14] 0 0
Up to 60 days after last dose
Secondary outcome [15] 0 0
All-cause mortality
Timepoint [15] 0 0
Up to 60 days after last dose
Secondary outcome [16] 0 0
AEs leading to permanent treatment discontinuation
Timepoint [16] 0 0
Up to 60 days after last dose
Secondary outcome [17] 0 0
Change from baseline in liver function test
Timepoint [17] 0 0
Up to 60 days after last dose
Secondary outcome [18] 0 0
Change from baseline in fasting lipid panel
Timepoint [18] 0 0
Up to 60 days after last dose

Eligibility
Key inclusion criteria
* Participants with moderate-to-severe plaque psoriasis:

1. Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
2. Have at least 1 of the following cardiovascular risk factors:
* Current cigarette smoker
* Diagnosis of hypertension
* Diagnosis of hyperlipidemia
* Diabetes mellitus type 1 or 2
* History of one or more of the following cardiovascular events: Coronary intervention (PCI) or coronary artery bypass grafting (CABG), myocardial infarction (heart attack), cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack
* Obesity
* Family history of premature coronary heart disease or sudden death in a first-degree male relative younger than 55 years of age or in a first-degree female relative younger than 65 years of age.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day 1.
* Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a cardiac hospitalization (eg, pacemaker implantation, HF) within 90 days prior to Day 1.
* Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence).
* Other protocol define 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/10/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/01/2031
Actual
Sample size
Target
3040
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - 0271 - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - 0152 - Kogarah
Recruitment hospital [3] 0 0
Local Institution - 0216 - Westmead
Recruitment hospital [4] 0 0
Local Institution - 0285 - Woolloongabba
Recruitment hospital [5] 0 0
Local Institution - 0311 - Woolloongabba
Recruitment hospital [6] 0 0
Local Institution - 0282 - Carlton
Recruitment hospital [7] 0 0
Local Institution - 0345 - Clayton
Recruitment hospital [8] 0 0
Local Institution - 0103 - East Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3002 - East Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Liaoning
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Saint
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Saxony
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Japan
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Shiga
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Japan
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Gifu
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Itabashi-Ku
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Japan
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Kanazawa
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Japan
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Kurume, Fukuoka
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Japan
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Okayama
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Japan
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Sakaishi
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Mexico
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Estado de Baja California
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Mexico
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Jalisco
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Mexico
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Nuevo León
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Chihuahua City
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Lublin Voivodeship
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Podkarpackie Voivodeship
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Silesian Voivodeship
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Warmian-Masurian Voivodeship
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Wielkopolska
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Bialystok
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Gdansk
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Gdynia
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Katowice
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Lodz
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Mikolów
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Warsaw
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Wroclaw
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Swietokrzyskie Voivodeship
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Puerto Rico
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Caguas
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Romania
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Dolj
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Romania
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IS
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Romania
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MS
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Timi? County
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Brasov
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Bucharest
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Romania
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Constan?a
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Romania
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Ia?i
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South Korea
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Gyeonggi-do
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South Korea
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Seongnam-si
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South Korea
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Seoul
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Spain
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Las Palmas
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Spain
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Madrid
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Spain
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SE
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Sweden
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Borås
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Taiwan
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Kaohsiung
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Taiwan
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Taipei
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United Kingdom
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Bucks
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United Kingdom
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FIF
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United Kingdom
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Greater London
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United Kingdom
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Hampshire
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United Kingdom
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LND
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ON
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United Kingdom
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SLF

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
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
8559073286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


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/NCT07116967