Comparing Deucravacitinib with Ustekinumab for plaque psoriasis
Official title: Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
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
- Phase 3
- 2 groups
- Sites in Québec, Calgary and 22 more cities
- Recruiting
Interventions
- Medication
Deucravacitinib
Specified dose on specified days
- Medication
Ustekinumab
Specified dose on specified days
Canadian Sites (34)
30 of 34 recruiting
- Recruiting
Dermatology Research Institute
Calgary, Alberta
- Recruiting
Beacon Dermatology
Calgary, Alberta
- Recruiting
Laser Rejuvenation Clinics Edmonton D.T. Inc.
Edmonton, Alberta
- Recruiting
Stratica Dermatology
Edmonton, Alberta
- Recruiting
Alberta Dermasurgery Centre
Edmonton, Alberta
- Recruiting
Vida Clinic Research
Edmonton, Alberta
- Recruiting
Interior Dermatology Centre
Kelowna, British Columbia
- Recruiting
Skin Care West
Nanaimo, British Columbia
- Recruiting
Enverus Medical Research
Surrey, British Columbia
- Recruiting
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba
- Recruiting
Dr Tracey Brown-Maher Dermatology Clinic and Research Centre
St. John's, Newfoundland and Labrador
- Recruiting
CCA Medical Research
Ajax, Ontario
- Recruiting
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario
- Recruiting
Centricity Research London Victoria Multispecialty
London, Ontario
- Recruiting
Lovegrove Dermatology
London, Ontario
- Recruiting
DermEffects
London, Ontario
- Recruiting
Lynderm Research Inc.
Markham, Ontario
- Recruiting
DermEdge
Mississauga, Ontario
- Recruiting
Ryan Clinical Research Inc
Newmarket, Ontario
- Recruiting
North Bay Dermatology Centre
North Bay, Ontario
- Recruiting
The Centre for Clinical Trials Inc.
Oakville, Ontario
- Recruiting
JRB Research Inc.
Ottawa, Ontario
- Recruiting
SKiN Centre for Dermatology
Peterborough, Ontario
- Recruiting
The Centre for Dermatology
Richmond Hill, Ontario
- Recruiting
North York Research Inc.
Toronto, Ontario
- Recruiting
Toronto Research Centre
Toronto, Ontario
- Recruiting
Centre de Recherche Saint-Louis
Québec
- Recruiting
Centre de Recherche Saint-Louis
Montreal, Quebec
- Recruiting
Centre de Recherche Saint-Louis
Sherbrooke, Quebec
- Recruiting
Sima Recherche
Verdun, Quebec
- Withdrawn
Local Institution - 0126
Calgary, Alberta
- Not yet recruiting
Local Institution - 0120
Surrey, British Columbia
- Not yet recruiting
Local Institution - 0005
Hamilton, Ontario
- Not yet recruiting
Local Institution - 0506
Toronto, Ontario
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants with moderate-to-severe plaque psoriasis:
- +Deemed by the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
- +Have at least 1 of the following cardiovascular risk factors:
- +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
- +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.
- +Current cigarette smoker
Exclusion
- −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 protocolProtocolThe detailed plan a study must follow.Read more → define inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Deucravacitinib.
Registry label: A: Arm A
Group B, the comparison group, receives Ustekinumab.
Registry label: B: Arm B
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 40 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 3,040 people.
The study is currently expected to finish around January 2031.
The main measurement is taken over: Up to 5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization — measured over Up to 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07116967 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About DeucravacitinibDrug
Specified dose on specified days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About UstekinumabDrug
Specified dose on specified days
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 40 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 40 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 5 years.
The study as a whole is currently expected to finish around 2031-01-16.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 3,040 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 37 locations, including: Québec, Canada; Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Kelowna, British Columbia, Canada; Nanaimo, British Columbia, Canada; Surrey, British Columbia, Canada, and 31 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Other Sites (13)
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States
Somerset Skin Centre
Troy, Michigan, United States
Michigan Dermatology Institute - Waterford
Waterford, Michigan, United States
Minnesota Clinical Study Center (MCSC)
New Brighton, Minnesota, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
The Skin Center Dermatology Group
New City, New York, United States
Local Institution - 0410
New York, New York, United States
Skin Search Rochester
Rochester, New York, United States
Elyse S. Rafal, MD PC - Rafal Center for Dermatology & Cosmetic Surgery
Stony Brook, New York, United States
Equity Medical - New York
The Bronx, New York, United States
Frontier Dermatology
Mill Creek, Washington, United States
Premier Clinical Research
Spokane, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.