This study involves people with moderate to severe plaque psoriasis, which is a skin condition that causes red, scaly patches on the skin. The treatments being compared in this study are deucravacitinib, which is taken as a tablet by mouth, and ustekinumab, which is given as an injection under the skin. The purpose of this study is to assess the cardiovascular safety of long-term use of deucravacitinib in comparison to ustekinumab in adults with moderate to severe plaque psoriasis. Cardiovascular safety refers to how these medications may affect the heart and blood vessels over time.
People taking part in this study will be adults aged 40 years or older who have moderate to severe plaque psoriasis and who have at least one risk factor that may affect heart health, such as smoking, high blood pressure, high cholesterol, diabetes, obesity, or a family history of heart disease. During the study, participants will receive either deucravacitinib or ustekinumab for up to 60 months. The study will monitor for various heart and blood vessel problems, including heart attacks, strokes, procedures to open blocked blood vessels in the heart, blood clots in the legs or lungs, and heart failure requiring hospital care.
Throughout the study, participants will have regular check-ups that include blood tests to check liver function and cholesterol levels. The study will also track other safety concerns such as serious side effects, infections, and skin cancers. Information will be collected about any side effects that lead to stopping the medication and about deaths from any cause. This study is designed to run for several years to understand the long-term safety of these treatments in people with psoriasis who have risk factors for heart disease.
1Treatment assignment
At the start of the study, you will be randomly assigned to receive one of two treatment options. This process is called randomization and ensures fair distribution of participants.
You will receive either deucravacitinib tablets taken by mouth or ustekinumab injections given under the skin.
2Treatment with deucravacitinib
If you are assigned to deucravacitinib, you will take this medication in the form of film-coated tablets by mouth.
The specific dosage, frequency, and exact timing of taking the tablets will be provided to you by the study staff.
You will continue taking this medication for the duration of the study as directed.
3Treatment with ustekinumab
If you are assigned to ustekinumab, you will receive this medication through injections under the skin.
The specific dosage and schedule of injections will be provided to you by the study staff.
You will continue receiving this medication for the duration of the study as directed.
4Regular monitoring visits
Throughout the study, you will attend regular monitoring visits.
At baseline and then every 26 weeks, you will have laboratory tests performed. These tests will include a complete metabolic panel, which checks how your body is processing nutrients and how your organs are functioning.
Your liver function will be tested to ensure your liver is working properly.
A fasting lipid panel will be performed to measure cholesterol and fat levels in your blood. You will need to fast before this test, meaning you should not eat for a certain period before the blood is drawn.
5Safety monitoring
During the study, you will be monitored for any adverse events, which are unwanted or harmful effects that may occur during treatment.
Particular attention will be given to monitoring for heart and blood vessel problems, including heart attacks, strokes, blood clots, and heart failure requiring urgent medical care.
You will also be monitored for infections, including tuberculosis and certain types of herpes zoster infections.
Any new cancers, excluding a specific type of skin cancer called non-melanoma skin cancer, will be recorded.
The study staff will track any serious adverse events and any side effects that might lead to stopping your treatment permanently.
6Long-term participation
This is a long-term safety study, meaning you will participate for an extended period.
The study is expected to continue until January 2031, though your individual participation time may vary.
You will continue with your assigned treatment and attend all scheduled visits as instructed by the study staff.
Who Can Join the Study?
You must be 40 years of age or older
You must have moderate to severe plaque psoriasis, which is a skin condition that causes red, scaly patches on the skin
Your psoriasis must meet specific measurements: a PASI score of 12 or higher (PASI is a scoring system that measures how severe your psoriasis is based on redness, thickness, and scaling), BSA of 10% or more (BSA means body surface area, which is the percentage of your body covered by psoriasis), and an sPGA score of 3 or higher (sPGA is a doctor’s rating of your overall psoriasis severity)
You must be a suitable candidate for phototherapy (treatment using special light) or systemic treatment (medicines that work throughout your whole body) for your psoriasis
You must have at least one of the following heart and blood vessel risk factors: you currently smoke cigarettes, you have been diagnosed with high blood pressure or take medicines to lower blood pressure, you have been diagnosed with dyslipidemia (abnormal levels of fats in your blood such as cholesterol), you have diabetes type 1 or type 2 (a condition affecting blood sugar levels), you have had a history of heart problems such as procedures to open blocked arteries (PCI or CABG), heart attack, cardiac arrest (when the heart stops beating), hospitalization for severe chest pain or heart-related chest pain, stroke (when blood flow to the brain is blocked), or transient ischemic attack (a temporary blockage of blood flow to the brain, sometimes called a mini-stroke), you have obesity with a body mass index of 30 or higher (BMI is a measure of body fat based on your height and weight), or you have a family history of early heart disease in close relatives
Who Cannot Join the Study?
The study has not provided specific exclusion criteria, which are reasons why a patient cannot participate in the clinical trial
You should contact the study team directly to learn about any conditions or situations that would prevent you from joining this study
Common reasons for not being able to participate in studies like this may include having certain other health conditions, taking specific medications, or having had recent treatments, but these have not been specified for this particular trial
Deucravacitinib is a medication being tested for the treatment of moderate-to-severe plaque psoriasis, which is a skin condition that causes red, scaly patches on the skin. This medicine works by affecting certain processes in the immune system that contribute to inflammation and skin symptoms. In this study, researchers want to learn more about how safe this medication is for the heart and blood vessels when used for a long time.
Ustekinumab is an approved medication used to treat moderate-to-severe plaque psoriasis. It works by blocking certain proteins in the body that cause inflammation and lead to psoriasis symptoms. This medication is already used by doctors to help patients with psoriasis, and it serves as a comparison treatment in this study to evaluate the safety of the other medication being tested.
Plaque Psoriasis – Plaque psoriasis is a chronic skin condition that causes red, raised patches covered with silvery-white scales to appear on the skin. These patches, called plaques, most commonly develop on the elbows, knees, scalp, and lower back, but can occur anywhere on the body. The affected skin is often itchy and sometimes painful, and the plaques may crack and bleed. The condition occurs when the immune system mistakenly speeds up the growth cycle of skin cells, causing them to build up rapidly on the surface. Plaque psoriasis typically follows a pattern of flare-ups, when symptoms worsen, followed by periods of improvement or remission. The severity can range from a few small patches to extensive areas of affected skin covering large portions of the body.
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