Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Plaque PsoriasisA study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
40 and up
Participation Criteria
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.
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 Location
Local Institution - 0126
Local Institution - 0126Calgary, Alberta
Canada
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Site 0126
Skin Care West
Skin Care WestNanaimo, British Columbia
Canada
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Gabriele Weichert, Site 0431
250-740-2125Local Institution - 0098
Local Institution - 0098St. John's, Newfoundland and Labrador
Canada
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Site 0098
Centricity Research London Victoria Multispecialty
Centricity Research London Victoria MultispecialtyLondon, Ontario
Canada
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Jeffery Cowger, Site 0004
5198731654DermEdge
DermEdgeMississauga, Ontario
Canada
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Mark Lomaga, Site 0141
9052749996Local Institution - 0003
Local Institution - 0003Ottawa, Ontario
Canada
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Site 0003
Toronto Research Centre
Toronto Research CentreToronto, Ontario
Canada
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Maxwell Sauder, Site 0173
6478689944Local Institution - 0491
Local Institution - 0491Edmonton, Alberta
Canada
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Site 0491
Enverus Medical Research
Enverus Medical ResearchSurrey, British Columbia
Canada
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Lorne Albrecht, Site 0006
6044958278SimcoDerm Medical and Surgical Dermatology Center
SimcoDerm Medical and Surgical Dermatology CenterBarrie, Ontario
Canada
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Maryam Alam, Site 0007
7055036331DermEffects
DermEffectsLondon, Ontario
Canada
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Wei Jing Loo, Site 0137
2269197887North Bay Dermatology Centre
North Bay Dermatology CentreNorth Bay, Ontario
Canada
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Leslie Rosoph, Site 0489
17054763967The Centre for Dermatology
The Centre for DermatologyRichmond Hill, Ontario
Canada
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Mani Raman, Site 0488
905-889-2005Local Institution - 0477
Local Institution - 0477Sherbrooke, Quebec
Canada
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Site 0477
Local Institution - 0013
Local Institution - 0013Calgary, Alberta
Canada
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Interior Dermatology Centre
Interior Dermatology CentreKelowna, British Columbia
Canada
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Wiseman Dermatology Research Inc.
Wiseman Dermatology Research Inc.Winnipeg, Manitoba
Canada
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Local Institution - 0005
Local Institution - 0005Hamilton, Ontario
Canada
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Local Institution - 0300
Local Institution - 0300Markham, Ontario
Canada
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Local Institution - 0498
Local Institution - 0498Oakville, Ontario
Canada
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North York Research Inc.
North York Research Inc.Toronto, Ontario
Canada
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Local Institution - 0142
Local Institution - 0142Verdun, Quebec
Canada
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Local Institution - 0014
Local Institution - 0014Edmonton, Alberta
Canada
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Local Institution - 0120
Local Institution - 0120Surrey, British Columbia
Canada
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CCA Medical Research
CCA Medical ResearchAjax, Ontario
Canada
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Lovegrove Dermatology
Lovegrove DermatologyLondon, Ontario
Canada
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Ryan Clinical Research Inc
Ryan Clinical Research IncNewmarket, Ontario
Canada
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SKiN Centre for Dermatology
SKiN Centre for DermatologyPeterborough, Ontario
Canada
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Centre de Recherche Saint-Louis
Centre de Recherche Saint-LouisMontreal, Quebec
Canada
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- Study Sponsored By
- Bristol-Myers Squibb
- Participants Required
- More Information
- Study ID:
NCT07116967