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
Long-term safety study of Deucravacitinib vs Ustekinumab for psoriasis
Plain English Summary
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK) is a Phase 3 clinical trial sponsored by Bristol-Myers Squibb studying Plaque Psoriasis. Tests the long-term safety of Deucravacitinib compared to Ustekinumab for moderate-to-severe plaque psoriasis. For adults with moderate-to-severe plaque psoriasis who need phototherapy or systemic treatment. Participation involves taking study medication as directed and attending regular check-ups. Alternative treatments include other psoriasis medications or phototherapy. The trial aims to enroll 3040 participants.
Official Summary
A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis
Who Can Participate
Here is what you need to know about eligibility for this trial. Eligible participants have moderate-to-severe plaque psoriasis and at least one cardiovascular risk factor. Excluded are those with recent cardiovascular events, unstable cardiovascular conditions, or active cancer. Age range: 18 years and older. Health requirements: Must have moderate-to-severe plaque psoriasis and at least one cardiovascular risk factor. This trial is studying Plaque Psoriasis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures the risk of major adverse cardiovascular events, helping patients understand the potential long-term safety of the treatment. The specific primary outcome measures are: Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization (Up to 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses the long-term safety of Deucravacitinib compared to Ustekinumab, filling a gap in understanding the cardiovascular safety of these treatments over extended periods. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Plaque Psoriasis, where improved treatment options are needed.
Investor Insight
Market size is significant, with a large patient population needing long-term treatment for psoriasis. Competitive landscape includes other biologics, and approval probability is high given the sponso Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 3040 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if you have any cardiovascular risk factors and if you are a candidate for phototherapy or systemic treatment. Participation involves taking study medication as directed and attending regular check-ups. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 3,040 participants
Interventions
- DRUG: Deucravacitinib — Specified dose on specified days
- DRUG: Ustekinumab — Specified dose on specified days
Primary Outcomes
- Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization (Up to 5 years)
Secondary Outcomes
- Number of participants with non-fatal MI (Up to 5 years)
- Number of participants with non-fatal stroke (Up to 5 years)
- Death due to cardiovascular events (Up to 5 years)
- Number of participants with coronary revascularization (Up to 5 years)
- Number of participants with 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) (Up to 5 years)
Full Eligibility Criteria
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.
Trial Locations
- 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
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT07116967?
NCT07116967 is a Phase 3 INTERVENTIONAL study titled "Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)." It is currently recruiting and is sponsored by Bristol-Myers Squibb. The trial targets enrollment of 3040 participants.
What conditions does NCT07116967 study?
This trial investigates treatments for Plaque Psoriasis. The primary condition under study is Plaque Psoriasis.
What treatments are being tested in NCT07116967?
The interventions being studied include: Deucravacitinib (DRUG), Ustekinumab (DRUG). Specified dose on specified days
What does Phase 3 mean for NCT07116967?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07116967?
This trial is currently "Recruiting." It started on 2025-09-22. The estimated completion date is 2031-01-16.
Who is sponsoring NCT07116967?
NCT07116967 is sponsored by Bristol-Myers Squibb. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07116967?
The trial aims to enroll 3040 participants. The trial is currently recruiting and accepting new participants.
How is NCT07116967 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07116967?
The primary outcome measures are: Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization (Up to 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07116967 being conducted?
This trial is being conducted at 20 sites, including Birmingham, Alabama; Phoenix, Arizona; Scottsdale, Arizona; Tempe, Arizona and 16 more sites (United States).
Where can I find official information about NCT07116967?
The official record for NCT07116967 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07116967. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07116967 testing in simple terms?
Tests the long-term safety of Deucravacitinib compared to Ustekinumab for moderate-to-severe plaque psoriasis. For adults with moderate-to-severe plaque psoriasis who need phototherapy or systemic treatment.
Why is this trial significant?
This trial addresses the long-term safety of Deucravacitinib compared to Ustekinumab, filling a gap in understanding the cardiovascular safety of these treatments over extended periods. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07116967?
Key risks include potential cardiovascular events, though the study aims to identify these. Side effects may include injection site reactions, upper respiratory infections, and headache. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07116967?
Ask your doctor if you have any cardiovascular risk factors and if you are a candidate for phototherapy or systemic treatment. Participation involves taking study medication as directed and attending regular check-ups. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07116967 signal from an investment perspective?
Market size is significant, with a large patient population needing long-term treatment for psoriasis. Competitive landscape includes other biologics, and approval probability is high given the sponso This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves taking study medication as directed and attending regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.