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 or Had Previously Received TNFα Inhibitor Treatment

This research study is looking into a new medication called deucravacitinib. It's for people who have active psoriatic arthritis, a condition that causes joint pain and skin problems. The main aim is to find out if deucravacitinib is safe and if it works better than a placebo (a dummy pill with no active medicine) in reducing symptoms of psoriatic arthritis. They are also comparing it to another existing medicine called Apremilast. This study is specifically for individuals who haven't tried certain biological treatments before, or who have previously used a type of medicine called a TNF-alpha inhibitor. The study will also gather information on the long-term safety and effectiveness of deucravacitinib.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

729

Start

15 Jul 2021

Estimated completion

12 Nov 2026

Psoriatic Arthritis

Results

Results from this study

Posted April 2025

Results have been published for this study.

Primary outcome

Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16

The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.

Full results on the registry

What is this study about?

This study is trying to find out if a new medicine, deucravacitinib, can help people with active psoriatic arthritis. Psoriatic arthritis is a condition where your immune system mistakenly attacks your joints, causing pain, swelling, and stiffness. It can also affect your skin, causing patches of psoriasis. The researchers want to see if deucravacitinib is safe and effective in reducing these symptoms, especially when compared to a placebo (a dummy pill) or another existing medication called Apremilast.

Taking part in a study like this helps doctors learn more about new treatments. This is important because it can lead to better options for people living with psoriatic arthritis in the future. The study is particularly interested in people who haven't yet tried certain strong medications for their condition, or those who have tried a specific type of treatment for it in the past and are looking for other options.

The study will also follow people for a longer period to understand the effects of deucravacitinib over time. This helps to get a full picture of how well the medicine works and if there are any long-term side effects.

Key takeaways

This study is testing a new medication for active psoriatic arthritis.
It aims to see if deucravacitinib is safe and effective compared to a dummy pill or another medicine.
It's for people either new to certain biological treatments or who have tried specific ones before.
Participation involves regular clinic visits for checks, assessments, and blood tests.
You might receive the new drug, a placebo, or an existing medicine.
You can stop participating at any time if you wish.

Who may be eligible?

To join this study, you would need to have a diagnosis of psoriatic arthritis for at least three months. You should also be experiencing active arthritis, meaning you have at least three swollen joints and three tender joints when checked. Your doctor will also look for signs of inflammation in your blood.

Importantly, this study is for specific groups: either you haven't received certain types of strong biological medicines for your psoriatic arthritis or psoriasis before, or you have tried a TNF-alpha inhibitor in the past. You also need to have current or past psoriasis on your skin.

There are certain reasons you might not be able to join. For example, if you have other autoimmune conditions like lupus, or if your joint pain is caused by a different condition like rheumatoid arthritis or gout. You also can't have received experimental or approved biological (biologic) therapies for your psoriatic arthritis or psoriasis in the past.

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.

Have I been diagnosed with psoriatic arthritis for at least 3 months?
Do I currently have active joint swelling and tenderness?
Do I have current or a history of psoriasis on my skin?
Have I never taken certain strong biological treatments for my condition, or have I only taken TNF-alpha inhibitors before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new study medication called deucravacitinib, a placebo (a dummy pill), or an existing medication called Apremilast. All medications would be provided by the study. You would have regular visits to the clinic for medical check-ups, assessments of your joints and skin, and blood tests. These visits help the study doctors monitor your health and how the medication is affecting you. The study includes an initial treatment period and then a longer-term follow-up period to understand the effects of the medication over time. The exact number and frequency of visits, as well as the total duration, would be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment before it's widely available, which might improve your psoriatic arthritis symptoms. You would also receive close medical attention and monitoring throughout the study. However, there are potential risks, including side effects from the medication (which will be fully explained) or that the treatment might not work for you. You might also receive a placebo, meaning you wouldn't get the active study drug. It's vital to remember that participating is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (138)

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

Local Institution - 0149
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Mountain Brook, United States
Local Institution - 0212
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Sacramento, United States
Local Institution - 0188
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Whittier, United States
Local Institution - 0192
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Skokie, United States
Local Institution - 0203
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Hopkinsville, United States
Local Institution - 0195
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Baton Rouge, United States
Local Institution - 0169
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Cumberland, United States
Local Institution - 0034
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Okemos, United States
Local Institution - 0133
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Eagan, United States
Local Institution - 0109
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Hattiesburg, United States
Local Institution - 0108
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New York, United States
Local Institution - 0186
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Rochester, United States

Common questions

What is psoriatic arthritis?

Psoriatic arthritis is a type of arthritis that affects some people with psoriasis. It causes joint pain, stiffness, and swelling, and can also affect other parts of the body.

What is a placebo?

A placebo is a 'dummy pill' or treatment that looks exactly like the real medicine but contains no active ingredients. It's used in studies to see if the new medicine works better than doing nothing or believing you're getting medicine.

What are 'biological treatments'?

Biological treatments are strong medicines that target specific parts of the immune system to reduce inflammation. They are often used for conditions like psoriatic arthritis when other treatments haven't worked.

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

Usually, in this type of study, neither you nor your doctor will know whether you are receiving the active drug or the placebo. This is called 'blinding' and helps ensure the study results are accurate.

How long will the study last?

The study involves an initial treatment period and then a longer follow-up period to gather more information. The exact duration will be explained by the study team if you express interest.