Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
3,040
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Lead sponsor
Bristol-Myers Squibb
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Start date
2025-09-22
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Number of sites
402
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Summary
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
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Short title
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
clinicaltrials.gov
Official 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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2031-01-16
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First posted
2025-08-12
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Registry last updated
2026-08-21
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Primary completion date
2031-01-16
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Start date
2025-09-22
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Participants
3,040
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Participant count basis
Estimated
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Planned participants
3,040
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Protocol amendments
0
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Number of sites
402
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Bristol-Myers Squibb
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07116967
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ClinicalTrials.gov ID
NCT07116967
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization

    Timeframe: Up to 5 years

    MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death

  1. Number of participants with non-fatal MI

    Timeframe: Up to 5 years

  2. Number of participants with non-fatal stroke

    Timeframe: Up to 5 years

  3. Death due to cardiovascular events

    Timeframe: Up to 5 years

  4. Number of participants with coronary revascularization

    Timeframe: Up to 5 years

  5. Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death)

    Timeframe: Up to 5 years

  6. Number of participants with pulmonary embolism (PE)

    Timeframe: Up to 5 years

  7. Number of participants with deep vein thrombosis (DVT)

    Timeframe: Up to 5 years

  8. Number of participants with composite venous thromboembolism (VTE)

    Timeframe: Up to 5 years

    PE, DVT and retinal vein occlusion

  9. Number of participants with arterial thromboembolic events (including retinal artery occlusion)

    Timeframe: Up to 5 years

  10. Number of participants with heart failure (HF) requiring hospitalization or urgent visit

    Timeframe: Up to 5 years

  11. Number of participants with Malignancy excluding non-melanoma skin cancer (NMSC)

    Timeframe: Up to 5 years

  12. Number of participants with NMSC

    Timeframe: Up to 5 years

  13. Number of participants with opportunistic infections

    Timeframe: Up to 5 years

    Opportunistic infections include tuberculosis and complicated herpes zoster (eg, disseminated herpes zoster, affecting more than 2 dermatomes, ophthalmic or meningoencephalopathic involvement, and other atypical presentations)

  14. Number of participants with Serious AEs (SAEs)

    Timeframe: Up to 60 days after last dose

  15. All-cause mortality

    Timeframe: Up to 60 days after last dose

  16. AEs leading to permanent treatment discontinuation

    Timeframe: Up to 60 days after last dose

  17. Change from baseline in liver function test

    Timeframe: Up to 60 days after last dose

  18. Change from baseline in fasting lipid panel

    Timeframe: Up to 60 days after last dose

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
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  • Local Institution - 0088Birmingham, United StatesNot yet recruiting
  • Medical Dermatology Specialists - PhoenixPhoenix, United StatesRecruiting
  • Saguaro Dermatology - PhoenixPhoenix, United StatesRecruiting
  • Omni DermatologyPhoenix, United StatesRecruiting
  • Alliance DermatologyPhoenix, United StatesRecruiting
  • Local Institution - 0322Scottsdale, United StatesWithdrawn
  • Local Institution - 0188Scottsdale, United StatesWithdrawn
  • Scottsdale Clinical TrialsScottsdale, United StatesRecruiting
  • Omni DermatologyTempe, United StatesRecruiting
  • Clinical Trials Institute of Northwest ArkansasFayetteville, United StatesRecruiting
  • Northwest Arkansas Clinical Trials Center (NWACTC), PLLCRogers, United StatesRecruiting
  • California Dermatology & Clinical Research InstituteEncinitas, United StatesRecruiting
  • T. Joseph Raoof MD IncEncino, United StatesRecruiting
  • First OC Dermatology - Fountain ValleyFountain Valley, United StatesRecruiting
  • Center For Dermatology Clinical Research, Inc.Fremont, United StatesRecruiting
  • Marvel Clinical ResearchHuntington Beach, United StatesRecruiting
  • Dermatology Research Associates - Howard Sofen, MDLos Angeles, United StatesRecruiting
  • Wallace Skin & Body InstituteLos Angeles, United StatesRecruiting
  • Northridge Clinical Trials - Elite Clinical NetworkNorthridge, United StatesRecruiting
  • Cura Clinical Research - PalmdalePalmdale, United StatesRecruiting
  • Pasadena Clinical TrialsPasadena, United StatesRecruiting
  • Empire Clinical Research - PomonaPomona, United StatesRecruiting
  • Integrative Skin Science and ResearchSacramento, United StatesRecruiting
  • UC Davis Dermatology ClinicSacramento, United StatesRecruiting
  • Local Institution - 0078San Diego, United StatesWithdrawn

And 377 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • U1111-1291-5815
  • 2023-503766-24
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Targets (4)