Active not recruitingPHASE3INTERVENTIONAL

A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

This research study is testing a new drug called deucravacitinib for people suffering from active psoriatic arthritis. The main goal is to find out if this new medicine is effective at reducing symptoms and improving the lives of those with the condition, and to check if it's safe to use. We're especially looking for people who haven't yet tried stronger, newer types of arthritis medicines called 'biologics'. The study compares deucravacitinib to a 'placebo', which is a dummy pill with no active medicine, to clearly see the drug's effects. There will also be a longer-term part of the study to gather more information about its safety and how well it works over time.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

670

Start

13 Jul 2021

Estimated completion

10 Jun 2027

Psoriatic Arthritis

Results

Results from this study

Posted October 2025

Results have been published for this study.

Primary outcome

Percentage of Participants With ACR 20 Response at Week 16

The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.

Full results on the registry

What is this study about?

This study is about a condition called psoriatic arthritis, which affects some people who have psoriasis. It can cause swelling, pain, and stiffness in the joints. Doctors are always looking for better ways to help people manage their symptoms, and this study focuses on a new medicine called deucravacitinib.

Researchers want to see if deucravacitinib can help ease the symptoms of psoriatic arthritis, like joint pain and swelling. They also need to make sure the medicine is safe. To do this, they will compare it to a 'placebo', which looks like the real medicine but contains no active drug. This helps them understand whether any improvements are due to the medicine itself or other factors.

This is a 'Phase 3' study, which means the medicine has already been carefully tested in smaller groups and is now being trialled in a larger number of people to gather more proof before it can potentially be made available to everyone. Participants in this study will be people with active psoriatic arthritis who haven't previously used a particular type of strong medicine called 'biologics'. They will also track people for a longer period to see how the medicine works over time and if there are any long-term effects.

Key takeaways

This study is testing a new medicine for active psoriatic arthritis.
It's for people who haven't used certain stronger arthritis medicines (biologics) before.
The new medicine, deucravacitinib, is compared against a dummy pill (placebo).
It will check both how well the medicine works and if it is safe.
Participation involves regular visits and monitoring over a potentially long period.

Who may be eligible?

To join this study, you would need to have been diagnosed with psoriatic arthritis for at least three months. Your arthritis should still be active, meaning you have noticeable swelling and tenderness in at least three joints. You should also have current or past skin psoriasis.

Crucially, you must not have used any 'biologic' medicines for your psoriatic arthritis or psoriasis in the past. These are specific types of stronger medicines your doctor might discuss with you. The study also looks for certain levels of inflammation in your blood and some evidence of joint damage on an X-ray.

You wouldn't be able to join if you have other conditions like lupus or rheumatoid arthritis, another type of inflammatory joint disease, or active fibromyalgia. Having certain types of psoriasis that aren't 'plaque psoriasis' would also mean you can't join. The research team will go through all the detailed requirements with you.

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 a diagnosis of psoriatic arthritis that's at least 3 months old?
Do I currently have active arthritis with at least 3 swollen and 3 tender joints?
Do I currently have, or have I had in the past, skin psoriasis (plaque type)?
Have I *never* received a 'biologic' medicine for my psoriatic arthritis or psoriasis?
Do I have an active inflammatory condition other than psoriatic arthritis, like lupus or rheumatoid arthritis? (If yes, you may not be eligible.)

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the study medicine, deucravacitinib, or a placebo (a dummy pill). You wouldn't know which one you are getting, and neither would your doctor, until the study is over. You'll have regular hospital or clinic visits where you'll have check-ups, blood tests, and assessments of your joints and skin. You'll need to keep track of your symptoms and any side effects you experience. The main treatment period lasts for about a year, followed by an optional longer period to gather more information. The total amount of time you would be involved could be several years.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new medicine for your psoriatic arthritis that might improve your symptoms, or getting closer monitoring of your condition. However, there are also potential risks, including side effects from the study medicine or the possibility that the medicine may not work for you. There might also be discomfort from tests and procedures. You can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (183)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 0197
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Gilbert, United States
Local Institution - 0188
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Jonesboro, United States
Local Institution - 0168
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Fontana, United States
Local Institution - 0199
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Fullerton, United States
Local Institution - 0038
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Sacramento, United States
Cohen Medical Centers
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Thousand Oaks, United States
Local Institution - 0170
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Denver, United States
Local Institution - 0195
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Clearwater, United States
Local Institution - 0272
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Margate, United States
Local Institution - 0082
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Miami Lakes, United States
Local Institution - 0171
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Gainesville, United States
Local Institution - 0087
Verified postcode
Boise, United States

Common questions

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers see if the real medicine is truly making a difference.

What are 'biologics' and why can't I have taken them?

Biologics are a strong type of medicine for conditions like psoriatic arthritis. This study is specifically for people who haven't tried them yet, to see how deucravacitinib works in that group.

Will I know if I'm getting the real medicine?

No, during the main part of the study, neither you nor your study doctor will know if you're receiving deucravacitinib or the placebo. This is to ensure fair and accurate results.

How long will I be in the study?

The main treatment part of the study lasts around a year, but there's an optional longer follow-up period which means your total involvement could be several years.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, and it will not affect your medical care.