Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
This research study, called PRAGMATYK, is looking into the long-term safety of a new medication called deucravacitinib for people living with moderate to severe plaque psoriasis. It compares it to an existing treatment, ustekinumab. The study is particularly interested in people who have plaque psoriasis and also some risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes, or a history of smoking. By carefully observing participants over time, the researchers aim to understand how safe deucravacitinib is compared to ustekinumab, helping to provide more information about future treatment options for psoriasis.
At a glance
What is this study about?
This study is designed to learn more about the long-term safety of two medicines used to treat a skin condition called moderate to severe plaque psoriasis. Psoriasis causes red, scaly patches on the skin, and these medicines work by calming down the immune system that causes the problem.
One of the medicines, ustekinumab, is already approved and used by many people with psoriasis. The other, deucravacitinib, is a newer medicine. The main goal is to see how safe deucravacitinib is over a long period, especially when compared to ustekinumab. This is important for doctors and patients to understand if deucravacitinib could be a good long-term option.
The study is particularly looking at people who, on top of having psoriasis, also have certain risk factors for heart disease. This might include things like high blood pressure, high cholesterol, diabetes, or if they smoke. By focusing on this group, researchers can gather important information about how these treatments affect people who might have other health concerns.
Key takeaways
- This study is testing the long-term safety of a new psoriasis medicine, deucravacitinib.
- It's comparing deucravacitinib to an existing psoriasis medicine, ustekinumab.
- The study focuses on people with moderate to severe plaque psoriasis who also have heart disease risk factors.
- It aims to understand if the new treatment is safe for this specific group of patients over time.
- Participation involves regular clinic visits and health monitoring.
Who may be eligible?
To join this study, you need to have moderate to severe plaque psoriasis. Your doctor must think that you would normally be considered for treatments like light therapy or other body-wide medicines for your psoriasis, including ustekinumab.
Crucially, you also need to have at least one risk factor for heart disease. This could include if you currently smoke, have been diagnosed with high blood pressure or high cholesterol, have diabetes (type 1 or type 2), or have a family history of heart disease at a younger age. Having a past heart event like a heart attack or stroke, or obesity, would also qualify.
However, you can't join if you've had a recent heart attack, stroke, or blood clot within the last 3 months, or if you have unstable heart disease that needs immediate attention. You also cannot have had active cancer or certain types of cancer within the last 5 years, unless it was a successfully treated minor skin cancer or early cervical cancer.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have moderate to severe plaque psoriasis?
- Does my doctor think I should consider light therapy or body-wide psoriasis medicines?
- Do I have a risk factor for heart disease (e.g., high blood pressure, diabetes, current smoker, obesity, family history)?
- Have I had a heart attack, stroke, or unstable heart condition in the last 3 months?
- Have I had cancer (other than successfully treated minor skin or cervical cancer) in the last 5 years?
What does participation involve?
The detailed involvement in this study isn't fully described here, but generally, taking part in a clinical trial involves receiving either deucravacitinib or ustekinumab as per the study’s plan. You would have regular visits to the clinic for health checks, blood tests, and to discuss any side effects or changes in your psoriasis. These visits would likely involve physical exams and questions about your health and how you are feeling. Throughout the study, your health will be carefully monitored. The total duration of the study is designed for long-term observation, meaning it could last for an extended period, potentially several years.
Potential risks and benefits
Locations (363)
- Local Institution - 0088Verified postcodeBirmingham, United States· Not yet recruiting
- Medical Dermatology Specialists - PhoenixVerified postcodePhoenix, United States· Recruiting
- Saguaro Dermatology - PhoenixVerified postcodePhoenix, United States· Recruiting
- Omni DermatologyVerified postcodePhoenix, United States· Recruiting
- Alliance DermatologyVerified postcodePhoenix, United States· Recruiting
- Local Institution - 0322Verified postcodeScottsdale, United States· Withdrawn
- Local Institution - 0188Verified postcodeScottsdale, United States· Withdrawn
- Scottsdale Clinical TrialsVerified postcodeScottsdale, United States· Recruiting
- Omni DermatologyVerified postcodeTempe, United States· Recruiting
- Clinical Trials Institute of Northwest ArkansasVerified postcodeFayetteville, United States· Recruiting
- Northwest Arkansas Clinical Trials Center (NWACTC), PLLCVerified postcodeRogers, United States· Recruiting
- California Dermatology & Clinical Research InstituteVerified postcodeEncinitas, United States· Recruiting
Common questions
What is plaque psoriasis?
Plaque psoriasis is a common skin condition that causes red, scaly patches, usually on the elbows, knees, scalp, and lower back.
What are deucravacitinib and ustekinumab?
They are both types of medicine used to treat psoriasis by affecting the immune system. Ustekinumab is an established treatment, while deucravacitinib is newer.
Why are heart disease risk factors important in this study?
Researchers want to understand how these psoriasis treatments affect people who also have risks for heart conditions, to ensure safety for a wider group of patients.
Will I know which medicine I'm getting?
Often in studies like this, you won't know if you're getting the new medicine or the existing one, to ensure fair results. Your doctor will know what treatment you are receiving if this is considered medically necessary.
What does a 'Phase 3' study mean?
Phase 3 means the new medicine has already shown promise in earlier studies, and this is a large study to confirm its safety and effectiveness before it might be approved for wider use.
How to find out more
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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