Active not recruitingPHASE3INTERVENTIONAL

Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

This research is a long-term study focusing on a new medicine called deucravacitinib for people living with psoriasis. If you've previously taken part in another study for this medicine, this trial will continue to monitor its safety and how well it works over a longer period. A special part of the study also investigates how deucravacitinib affects your body's response to two common vaccines: one for pneumonia and another for tetanus. This helps researchers understand if the medicine changes how well vaccines protect you. They will also look at how safe it is to give these vaccines to people with psoriasis who are taking deucravacitinib, compared to those taking a dummy medicine (placebo).

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

1,466

Start

12 Aug 2019

Estimated completion

26 Jul 2026

Psoriasis

What is this study about?

This study is really important because it helps us understand the long-term effects of a new medicine, deucravacitinib, for psoriasis. Psoriasis is a condition where your skin cells grow too quickly, leading to red, scaly patches. This particular trial is for people who have already started taking deucravacitinib in an earlier study. This means researchers are continuing to watch how safe the medicine is and how well it helps control psoriasis symptoms over a longer time. They want to make sure it's not only effective but also safe for continued use.

A special part of this study also looks at how your body's immune system, which fights off infections, reacts to vaccines while you're taking deucravacitinib. They're specifically testing two common vaccines: one for pneumonia (Pneumovax 23) and another for tetanus (Boostrix). This is vital because understanding how medicines like deucravacitinib interact with vaccines helps doctors advise patients on how best to stay protected from other illnesses. They'll compare vaccine responses in people taking deucravacitinib versus those on a dummy medicine (placebo).

By carefully studying these things, researchers can gather crucial information. This information helps regulatory bodies decide if the medicine is suitable for broader use and helps doctors understand how to prescribe and manage patients taking deucravacitinib in the future. It’s all about making sure medicines are both effective for your condition and safe for your overall health.

Key takeaways

This study is for people who have already been in another study for the psoriasis medicine deucravacitinib.
It aims to check the medicine's safety and effectiveness over a long period.
A special part of the study looks at how the medicine affects your body's response to common vaccines.
Participation involves ongoing use of the study medicine and regular health check-ups.
You must not be pregnant, breastfeeding, or planning to become pregnant if considering joining.
You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you must have already taken part in a previous study looking at the medicine deucravacitinib for moderate to severe psoriasis. You also need to have finished all the required treatment in that earlier study. Women intending to join must not be pregnant, breastfeeding, or planning to become pregnant.

There's also a specific group within the study, called the 'vaccine group'. To be in this group, you must have moderate to severe psoriasis, be currently taking deucravacitinib in a related study in the UK, Canada, or Poland, and have been taking the medicine for at least one year.

You would not be able to join if you have any other serious health conditions that the study doctor thinks could make the study unsafe for you. You also cannot join if you have active signs of tuberculosis (TB). If you are considering the vaccine group, you cannot have received the Pneumovax 23 vaccine in the last 5 years, or certain other pneumonia vaccines in the last year. You also can't have had the Boostrix vaccine in the last 5 years.

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 you already taken part in a study for deucravacitinib for psoriasis?
Are you able to attend regular appointments for check-ups and blood tests?
If you are female, are you not pregnant, breastfeeding, or planning to become pregnant?
Do you not have active tuberculosis (TB)?
If interested in the vaccine group, have you not had certain pneumonia or tetanus vaccines recently (within 1-5 years depending on vaccine)?
Are you generally healthy, apart from your psoriasis, as determined by the study doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive either deucravacitinib or a placebo (a dummy medicine) as determined by your previous study. The exact schedule of your visits and how long you'll be in the study will depend on your previous participation and if you join the vaccine part of the study. You'll have regular medical check-ups and provide blood samples. For those in the vaccine group, you will receive the pneumococcal and tetanus vaccines, followed by blood tests to check your body's response over a period of time. The total length of your participation will be discussed with you by the study team, but it is considered a long-term follow-up.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is continued access to deucravacitinib, which may continue to help manage your psoriasis. You'll also receive close medical attention and monitoring. Potential risks could include side effects from the study medicine, or reactions to the vaccines if you are in that part of the study. Your health will be carefully monitored throughout. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (302)

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

Total Skin and Beauty Dermatology Center
Verified postcode
Birmingham, United States
Local Institution - 0278
Verified postcode
Birmingham, United States
Alliance Dermatology and Mohs Center - Phoenix
Verified postcode
Phoenix, United States
Arizona Research Center
Verified postcode
Phoenix, United States
Synexus - Orange Grove Family Practice
Verified postcode
Tucson, United States
Johnson Dermatology
Verified postcode
Fort Smith, United States
Burke Pharmaceutical Research
Verified postcode
Hot Springs, United States
Northwest Arkansas Clinical Trials Center, PLLC
Verified postcode
Rogers, United States
Local Institution - 0046
Verified postcode
Fountain Valley, United States
Local Institution - 0206
Verified postcode
Fresno, United States
Local Institution - 0017
Verified postcode
Irvine, United States
Interspond - Long Beach Clinical Trials
Verified postcode
Long Beach, United States

Common questions

What is psoriasis?

Psoriasis is a long-lasting skin condition where your skin cells grow too quickly, leading to red, flaky, crusty patches covered with silvery scales.

What is deucravacitinib?

Deucravacitinib is a new medicine being studied to treat psoriasis. This study is looking at its long-term safety and how well it continues to work.

Why is the study looking at vaccines?

Researchers want to see how taking deucravacitinib affects your body's ability to respond to common vaccines, like those for pneumonia and tetanus. This helps doctors know how best to protect patients from other illnesses.

Will I know if I'm getting the actual medicine or a dummy pill?

Generally, in studies like this, you won't know if you're getting the active medicine or a placebo (dummy pill) to keep the results fair and unbiased. The study team will manage this.

Can I leave the study once I've joined?

Yes, you can leave the study at any time and for any reason. Your decision will not affect your usual medical care.