Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Long-term safety study of deucravacitinib compared to ustekinumab in adults with moderate to severe plaque psoriasis

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment 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.

  2. Step 2

    Treatment 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.

  3. Step 3

    Treatment 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.

  4. Step 4

    Regular 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.

  5. Step 5

    Safety 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.

  6. Step 6

    Long-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 trial?

5 criteria

  • 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 trial?

3 criteria

  • 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
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • 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.

What is already known about the treatment

  • Deucravacitinib

    Deucravacitinib is an oral medication taken by mouth that is currently being studied in clinical trials for the treatment of moderate to severe plaque psoriasis, a chronic skin condition that causes raised, red, scaly patches on the skin. This drug works by selectively blocking a specific enzyme called TYK2, which is part of the body's immune system and plays a key role in causing inflammation and abnormal skin cell growth in psoriasis. Deucravacitinib belongs to a class of medications known as TYK2 inhibitors, which help reduce the overactive immune response that leads to psoriasis symptoms.

  • Ustekinumab

    Ustekinumab is an injectable medication given under the skin or into a vein that is already approved and widely used for treating moderate to severe plaque psoriasis and other inflammatory conditions. This medication works by blocking two specific proteins in the immune system called interleukin-12 and interleukin-23, which are responsible for triggering inflammation and the rapid skin cell turnover seen in psoriasis. Ustekinumab is classified as a monoclonal antibody, a type of biologic therapy that targets specific parts of the immune system to reduce disease activity and improve skin symptoms.

Investigated diseases

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.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503766-24-00Protocol codeIM011-1130Estimated enrolment3 041 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).