RECRUITINGPhase 3INTERVENTIONAL
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
About This Trial
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Deucravacitinib
Specified dose on specified days
DRUG
Ustekinumab
Specified dose on specified days
Locations (20)
Local Institution - 0088
Birmingham, Alabama, United States
Medical Dermatology Specialists - Phoenix
Phoenix, Arizona, United States
Saguaro Dermatology - Phoenix
Phoenix, Arizona, United States
Omni Dermatology
Phoenix, Arizona, United States
Alliance Dermatology
Phoenix, Arizona, United States
Local Institution - 0322
Scottsdale, Arizona, United States
Local Institution - 0188
Scottsdale, Arizona, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Omni Dermatology
Tempe, Arizona, United States
Clinical Trials Institute of Northwest Arkansas
Fayetteville, Arkansas, United States
Northwest Arkansas Clinical Trials Center (NWACTC), PLLC
Rogers, Arkansas, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
T. Joseph Raoof MD Inc
Encino, California, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States
Marvel Clinical Research
Huntington Beach, California, United States
Dermatology Research Associates - Howard Sofen, MD
Los Angeles, California, United States
Local Institution - 0192
Los Angeles, California, United States
Northridge Clinical Trials - Elite Clinical Network
Northridge, California, United States
Cura Clinical Research - Palmdale
Palmdale, California, United States
Pasadena Clinical Trials
Pasadena, California, United States